xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06028243</url>
    </required_header>
    <id_info>
      <org_study_id>2021-12</org_study_id>
      <nct_id>NCT06028243</nct_id>
    </id_info>
    <brief_title>Awareness Model in Prevention of Osteoporosis</brief_title>
    <official_title>Assessment of the Effectiveness of the Healthy Living Awareness Program for the Prevention of Osteoporosis Based on the Information- Motivation- Behavioral Skills Model in University Students: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara Yildirim Beyazıt University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara Yildirim Beyazıt University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study investigated the effectiveness of a Healthy Living Awareness Program for the&#xD;
        Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model&#xD;
        (HLAPPO-IMB) in university students. The study adopted a randomized controlled trial&#xD;
        intervention pretest, posttest, and follow-up research design. Participants were randomized&#xD;
        into intervention (n=43) and control groups (n=44). Data were collected using a personal&#xD;
        information form, the Osteoporosis Knowledge Test, the Osteoporosis Health Belief Scale, the&#xD;
        Osteoporosis Self-Effective Scale, and the International Physical Activity Questionnaire&#xD;
        Short Form.&#xD;
  &#xD;
        The primary outcome measure was the participants' knowledge and health beliefs about&#xD;
        osteoporosis. The secondary outcome measure was the participants' healthy lifestyle behavior&#xD;
        skills (self-efficacy in weight-bearing exercises, taking calcium, and engaging in physical&#xD;
        activity).&#xD;
  &#xD;
        Research questions (RQ) RQ1: Does &quot;Healthy Living Awareness Program for the Prevention of&#xD;
        Osteoporosis based on the Information-Motivation-Behavioral Skills Model&quot; expand&#xD;
        participants' knowledge of osteoporosis? RQ2: Does &quot;Healthy Living Awareness Program for the&#xD;
        Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model&quot;&#xD;
        enhance participants' health beliefs? RQ3: Does &quot;Healthy Living Awareness Program for the&#xD;
        Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model&quot;&#xD;
        improve participants' self-efficacy in doing weight-bearing exercises and taking calcium?&#xD;
        RQ4: Does &quot;Healthy Living Awareness Program for the Prevention of Osteoporosis based on the&#xD;
        Information-Motivation-Behavioral Skills Model&quot; improve participants' self-efficacy in&#xD;
        engaging in physical activity?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study adopted a randomized controlled trial pretest, posttest, and follow-up research&#xD;
        design. The study was conducted between March and August 2021 at a public university in&#xD;
        Türkiye. The study adhered to the CONSORT (Consolidated Standards of Reporting Trials)&#xD;
        guidelines. Participants were randomized into intervention and control groups. Eligible&#xD;
        students were randomized to intervention group or control group using block randomization&#xD;
        technique. Blinding in the study was not feasible. Blinding could not be performed because&#xD;
        the researchers were aware of the interventions and carried out the implementation. The&#xD;
        intervention group attended the HLAPPO-IMB, which had three stages: information, motivation,&#xD;
        and behavioral skills development. The control group did not undergo the intervention.&#xD;
  &#xD;
        The study population consisted of 125 fifth-semester nursing students in the fall term of the&#xD;
        2020-2021 academic year. The undergraduate nursing programs in Türkiye are eight-semester&#xD;
        programs. The mean Osteoporosis Knowledge Test (OKT) scores were used to determine the sample&#xD;
        size. Power analyses were performed based on the difference between two independent means by&#xD;
        G*Power 3.1.9.7. A power analysis was performed to determine the sample size in line with the&#xD;
        literature [OKT: experimental group X̅±SD: 18.95±4.98 and control group X̅±SD: 15.18±3.88].&#xD;
        The results showed that a sample of 76 would be large enough to detect significant&#xD;
        differences (0.84 effect size, 0.05 level of error, and 95% power). All students who met the&#xD;
        inclusion criteria were recruited to avoid missing data. The first sample consisted of 87&#xD;
        participants, who were randomized to intervention (n=43) and control (n=44) groups. However,&#xD;
        one student from the intervention group declined to participate. Therefore, the final sample&#xD;
        consisted of 86 participants.&#xD;
  &#xD;
        The data were collected using a personal information form, the Osteoporosis Knowledge Test&#xD;
        (OKT), the Osteoporosis Health Belief Scale (OHSB), the Osteoporosis Self-Effective Scale&#xD;
        (OSES), and the International Physical Activity Questionnaire Short Form (IPAQ-SF).&#xD;
  &#xD;
        The personal information form: This form was prepared by the researchers. The form consisted&#xD;
        of 30 items on sociodemographic characteristics and factors that might affect bone mineral&#xD;
        density. Each participant's BMI, body weight, and body height were calculated based on&#xD;
        his/her self-report.&#xD;
  &#xD;
        Osteoporosis knowledge test: The instrument consists of 24 items. The total score ranges from&#xD;
        0 to 24, with higher scores indicating more osteoporosis-related knowledge.&#xD;
  &#xD;
        Osteoporosis health belief scale: The instrument consists of 42 items rated on a Likert-type&#xD;
        scale. The total score ranges from 42 to 210, with higher scores indicating more positive&#xD;
        health beliefs about osteoporosis.&#xD;
  &#xD;
        Osteoporosis self-effective scale: The scale consists of 12 items and two subscales: The&#xD;
        Osteoporosis Self-Efficacy Exercise Scale (six items: starting an exercise program, changing&#xD;
        exercise habits, doing appropriate exercise, etc.) and the Osteoporosis Self-Efficacy Calcium&#xD;
        Scale (six items: increasing calcium intake, choosing calcium-rich foods, maintaining dietary&#xD;
        calcium intake, etc.). The total score of each subscale ranges from 0 to 600. The total score&#xD;
        ranges from 0 to 1200, with higher scores indicating better self-efficacy in weight-bearing&#xD;
        exercises and taking calcium.&#xD;
  &#xD;
        International physical activity questionnaire short form: The form consists of seven items on&#xD;
        physical activity. The total score is the &quot;Metabolic Equivalent of Task minute/week (MET&#xD;
        min/week).&quot; The total score is calculated as &quot;MET min/week&quot; by multiplying the minute, day,&#xD;
        and MET values. Physical activity levels are classified as low (&lt;600 MET min/week), moderate&#xD;
        (600-3000 MET min/week), or high (&gt;3000 MET min/week) according to the total MET min/week&#xD;
        values.&#xD;
  &#xD;
        Healthy life diary: The researchers developed the Healthy Life Diary to monitor the&#xD;
        intervention group participants' healthy lifestyle behaviors to protect themselves from&#xD;
        osteoporosis. The intervention group participants filled out the diary regularly and noted&#xD;
        their daily calcium intake, type and duration of exercise, duration and time of sunlight&#xD;
        exposure, and amount of tobacco, coffee, tea, cola, etc.&#xD;
  &#xD;
        Procedure: The data were collected online because of the COVID-19 pandemic. The researchers&#xD;
        briefed students on the research procedure and texted them a link to the survey on WhatsApp.&#xD;
        The first page of the survey was a consent form. After obtaining informed consent, the&#xD;
        researchers directed all students who agreed to participate to the inclusion criteria&#xD;
        section. Students are a vulnerable population. Thus, the researchers took measures to ensure&#xD;
        students would not feel coerced to participate. The researchers informed all students about&#xD;
        the research purpose and procedure. Participation was voluntary. The researchers kept all&#xD;
        personal information confidential. All participants had pseudonyms.&#xD;
  &#xD;
        Healthy living awareness program for the prevention of osteoporosis: The intervention group&#xD;
        participants underwent the Healthy Living Awareness Program for the Prevention of&#xD;
        Osteoporosis (HLAPPO-IMB) in three stages based on IMB.&#xD;
  &#xD;
        Information stage: The researchers provided the intervention group participants with online&#xD;
        training in healthy living awareness to prevent osteoporosis (400 minutes and two days). They&#xD;
        held the training at all participants' convenience outside the class hours. The training&#xD;
        consisted of four sections: osteoporosis and diagnosis-treatment methods, current approaches&#xD;
        to the prevention of osteoporosis, osteoporosis and nutrition, and osteoporosis and physical&#xD;
        exercise. The researchers employed interactive teaching methods and consulted three experts&#xD;
        to prepare PowerPoint presentations. At the end of the training, the researchers taught the&#xD;
        intervention group participants how to fill out the healthy life diary, such as calculating&#xD;
        daily calcium intake. The researchers texted the intervention group participants all training&#xD;
        videos on WhatsApp to allow them to watch them again. All participants filled out the OKT and&#xD;
        OHSB (posttest) two and three weeks after the training. They filled them out again two months&#xD;
        after the posttest (follow-up).&#xD;
  &#xD;
        Motivation stage: The researchers regularly texted (WhatsApp) spot and reminder notifications&#xD;
        concerning the prevention of osteoporosis. They asked them to assess the health behaviors&#xD;
        they recorded in their diaries every week (daily calcium intake, weekly exercise duration,&#xD;
        etc.) and the problems they experienced during the process. The researchers provided&#xD;
        individual counseling to the participants by telephone (combating smoking, exercise barriers,&#xD;
        food exchange for calcium sources, etc.)&#xD;
  &#xD;
        Behavior skills stage: The target behavior skills were improved self-efficacy in doing&#xD;
        weight-bearing exercises, taking calcium, and engaging in physical activity. The OSES was&#xD;
        used to assess participants' self-efficacy to initiate and maintain behavior related to&#xD;
        exercise and calcium taking, while the IPAQ-SF was used to assess their physical activity&#xD;
        levels.&#xD;
  &#xD;
        Data analysis: The data were analyzed using the Statistical Package for Social Sciences.&#xD;
        Percentage, mean, and standard deviation were used for descriptive analysis. The categorical&#xD;
        variables were analyzed using the Pearson, Fisher χ2, and Marginal Homogeneity tests. The&#xD;
        Mann-Whitney U test was used to compare two independent groups. The Wilcoxon Signed Rank test&#xD;
        or Friedman nonparametric test was used for dependent measurement comparisons. The effect&#xD;
        size (r or Kendall W) was calculated for each comparison. The following limit values were&#xD;
        accepted for the interpretation of the effect sizes: r &lt; 0.29 &quot;small effect,&quot; r=0.30-0.49&#xD;
        &quot;medium effect,&quot; r ≥ 0.50 &quot;large effect.&quot; W effect size: &lt;0.39 &quot;small effect,&quot; 0.40-0.59&#xD;
        &quot;medium effect,&quot;≥ 0.60 &quot;large effect&quot;. The Mann-Whitney U Test was used to compare the&#xD;
        difference in age, menarche age, BMI, and scale scores between the groups. The Wilcoxon&#xD;
        Signed Rank test was used to compare the pretest and posttest scores. Friedman test was used&#xD;
        for repeated measures for dependent groups. Dunn's Bonferroni correction was used to&#xD;
        determine the source of the difference.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 26, 2021</start_date>
    <completion_date type="Actual">August 15, 2021</completion_date>
    <primary_completion_date type="Actual">May 18, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Blinding in the study was not feasible. Blinding could not be performed because the researchers were aware of the interventions and carried out the implementation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The effect of the program on the primary outcome-1 (Osteoporosis Knowledge Test)</measure>
      <time_frame>Pretest: 3 weeks, Completion of training: 2 weeks, Posttest: 2 weeks (2-3 weeks after training), Follow-up: 2 weeks (2 months after posttest). Total period of research: 20 weeks. Total application time of this scale: 7weeks.</time_frame>
      <description>Osteoporosis Knowledge Test consists of 24 items. The total score ranges from 0 to 24, with higher scores indicating more osteoporosis-related knowledge.&#xD;
  Osteoporosis Knowledge Test with Osteoporosis Health Belief Scale was applied three times (pretest, posttest and follow-up) to the intervention and control groups. Training was given to the intervention group after completing the Osteoporosis Knowledge Test (with other scales) as a pretest. After the training, it was applied to the participants as a posttest and follow-up. All participants filled out the Osteoporosis Knowledge Test with Osteoporosis Health Belief Scale (posttest) two and three weeks after the training. They filled them out again two months after the posttest (follow-up).&#xD;
  In the study protocol, pretest postest and follow up times are given in detail.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effect of the program on the primary outcome-2 (Osteoporosis Health Belief Scale)</measure>
      <time_frame>Pretest: 3 weeks, Completion of training: 2 weeks, Posttest: 2 weeks (2-3 weeks after training), Follow-up: 2 weeks (2 months after posttest). Total period of research: 20 weeks. Total application time of this scale: 7weeks.</time_frame>
      <description>Osteoporosis Health Belief Scale consists of 42 items rated on a Likert-type scale. The total score ranges from 42 to 210, with higher scores indicating more positive health beliefs about osteoporosis.&#xD;
  Osteoporosis Health Belief Scale with Osteoporosis Knowledge Test was applied three times (pretest, posttest and follow-up) to the intervention and control groups. Training was given to the intervention group after completing the Osteoporosis Health Belief Scale (with other scales) as a pretest. After the training, it was applied to the participants as a posttest and follow-up. All participants filled out the Osteoporosis Health Belief Scale with Osteoporosis Knowledge Test (posttest) two and three weeks after the training. They filled them out again two months after the posttest (follow-up).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The effect of the program on the secondary outcome-1 (Osteoporosis Self-Effective Scale)</measure>
      <time_frame>Pretest: 3 weeks, training and follow-up period: 15 weeks, Follow-up: 2 weeks. Total period of research: 20 weeks. Total application time of this scale: 5 weeks.</time_frame>
      <description>Osteoporosis Self-Effective Scale consists of 12 items and two subscales: The Osteoporosis Self-Efficacy Exercise Scale (six items: starting an exercise program, changing exercise habits, doing appropriate exercise, etc.) and the Osteoporosis Self-Efficacy Calcium Scale (six items: increasing calcium intake, choosing calcium-rich foods, maintaining dietary calcium intake, etc.). The total score of each subscale ranges from 0 to 600. The total score ranges from 0 to 1200, with higher scores indicating better self-efficacy in weight-bearing exercises and taking calcium.&#xD;
  Osteoporosis Self-Effective Scale was applied twice (pretest and follow-up) with International Physical Activity Questionnaire Short Form to the study groups. It was applied as a pretest with other scales. It was applied as a follow-up 13 weeks after the training.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effect of the program on the primary outcome-2 (International Physical Activity Questionnaire Short Form)</measure>
      <time_frame>Pretest: 3 weeks, training and follow-up period: 15 weeks, Follow-up: 2 weeks. Total period of research: 20 weeks. Total application time of this scale: 5 weeks.</time_frame>
      <description>International Physical Activity Questionnaire Short Form consists of seven items on physical activity. The total score is the &quot;Metabolic Equivalent of Task minute/week).&quot; The total score is calculated as &quot;Metabolic Equivalent of Task minute/week &quot; by multiplying the minute, day, and Metabolic Equivalent of Task values. Physical activity levels are classified as low, moderate, or high according to the total Metabolic Equivalent of Task min/week values. International Physical Activity Questionnaire Short Form was applied twice (pretest and follow-up) with Osteoporosis Self-Effective Scale to the study groups. It was applied as a pretest with other scales. It was applied as a follow-up 13 weeks after the training.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">87</enrollment>
    <condition>Osteoporosis</condition>
    <condition>University Students</condition>
    <condition>Healthy Lifestyle</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB) was implemented in three stages.&#xD;
  Information stage: The researchers provided the intervention group participants with online training in healthy living awareness to prevent osteoporosis. The training consisted of four sections: osteoporosis and diagnosis-treatment methods, current approaches to the prevention of osteoporosis, osteoporosis and nutrition, and osteoporosis and physical exercise. At the end of the training, the participants were informed about the healthy life diary and record.&#xD;
  Motivation stage: The researchers regularly texted reminder notifications concerning the prevention of osteoporosis. The records in their diaries were reviewed. The researchers provided individual counseling to the participants by telephone.&#xD;
  Behavior skills stage: The target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group was not trained. Data collection forms applied to the intervention group were also applied to the control group simultaneously.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stage</intervention_name>
      <description>The researchers provided the intervention group participants with online training in healthy living awareness to prevent osteoporosis (400 minutes and two days). They held the training at all participants' convenience outside the class hours. The training consisted of four sections: (1) osteoporosis and diagnosis-treatment methods, (2) current approaches to the prevention of osteoporosis, (3) osteoporosis and nutrition, and (4) osteoporosis and physical exercise. The researchers employed interactive teaching methods and consulted three experts to prepare PowerPoint presentations. At the end of the training, the researchers taught the intervention group participants how to fill out the healthy life diary, such as calculating daily calcium intake. The researchers texted the intervention group participants all training videos on WhatsApp to allow them to watch them again.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stage</intervention_name>
      <description>The researchers regularly texted (WhatsApp) spot and reminder notifications concerning the prevention of osteoporosis. They asked them to assess the health behaviors they recorded in their diaries every week (daily calcium intake, weekly exercise duration, etc.) and the problems they experienced during the process. The researchers provided individual counseling to the participants by telephone (combating smoking, exercise barriers, food exchange for calcium sources, etc.)</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stage</intervention_name>
      <description>The target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  having received no training on osteoporosis before&#xD;
  &#xD;
            -  having no disability that prevents physical activity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  involuntary&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>26 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>SİBEL PEKSOY KAYA, Asst. Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY</affiliation>
    </overall_official>
    <overall_official>
      <last_name>SENA KAPLAN, Prof. Dr.</last_name>
      <role>Study Director</role>
      <affiliation>ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY</affiliation>
    </overall_official>
    <overall_official>
      <last_name>ESRA BAŞKAYA, Dr.</last_name>
      <role>Study Director</role>
      <affiliation>ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ankara Yildirim Beyazit University</name>
        <address>
          <city>Ankara</city>
          <zip>06760</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Aktas O, Kaplan S, Sezer N. An assessment of the relation between bone mineral density and clinic-demographic properties and life quality during postmenopausal period. J Back Musculoskelet Rehabil. 2018;31(5):803-810. doi: 10.3233/BMR-170933.</citation>
      <PMID>29865030</PMID>
    </reference>
    <reference>
      <citation>Alpar, R. (2022). Spor Sağlık ve Eğitim Bilimlerinden Örneklerle Uygulamalı İstatistik ve Geçerlik Güvenirlik; (7th edition). Ankara: Detay Yayıncılık.</citation>
    </reference>
    <reference>
      <citation>Bahrami Z, Zarani F. Application of the Information-Motivation and Behavioral Skills (IMB) model in risky sexual behaviors amongst male students. J Infect Public Health. 2015 Mar-Apr;8(2):207-13. doi: 10.1016/j.jiph.2014.09.005. Epub 2014 Nov 22.</citation>
      <PMID>25466597</PMID>
    </reference>
    <reference>
      <citation>Barley E, Lawson V. Using health psychology to help patients: theories of behaviour change. Br J Nurs. 2016 Sep 8;25(16):924-7. doi: 10.12968/bjon.2016.25.16.924.</citation>
      <PMID>27615529</PMID>
    </reference>
    <reference>
      <citation>Bonjour JP, Theintz G, Law F, Slosman D, Rizzoli R. Peak bone mass. Osteoporos Int. 1994;4 Suppl 1:7-13. doi: 10.1007/BF01623429.</citation>
      <PMID>8081064</PMID>
    </reference>
    <reference>
      <citation>Bonjour, P., Compston, J., Dawson-Hughes, B., Delmas, P., Lyon, H. E. H., Ms, F., Johansson, H., Kanis, J. A., Lau, E., Yuen, L., Centre, H., Kong, H., Dr, C., Lindsay, R., Mcclung, M. R., Oden, A., Pfleger, B., Teilen, M. G., Clark Hospital De Especialidades, P., … Toroptsova, N. (2007). Assessment of Osteoporosis at The Primary Health Care Level. www.who.int/chp/topics/rheumatic/en/index.html</citation>
    </reference>
    <reference>
      <citation>Cooper, C., &amp; Ferrari, S. (2019). IOF Compendium of Osteoporosis (2nd Edition). Switzerland: International Osteoporosis Foundation.</citation>
    </reference>
    <reference>
      <citation>Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.</citation>
      <PMID>12900694</PMID>
    </reference>
    <reference>
      <citation>EQUATOR guidelines. (2020). Checklist for reporting a randomised trial. Retrieved from: https://www.goodreports.org/reporting-checklists/consort/</citation>
    </reference>
    <reference>
      <citation>Haleem A, Javaid M, Vaishya R. Effects of COVID-19 pandemic in daily life. Curr Med Res Pract. 2020 Mar-Apr;10(2):78-79. doi: 10.1016/j.cmrp.2020.03.011. Epub 2020 Apr 3. No abstract available.</citation>
      <PMID>32292804</PMID>
    </reference>
    <reference>
      <citation>Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos. 2013;8(1):136. doi: 10.1007/s11657-013-0136-1. Epub 2013 Oct 11.</citation>
      <PMID>24113837</PMID>
    </reference>
    <reference>
      <citation>Hosseini, Z., Karimi, Z., Mohebi, S., Reza Sharifirad, G., Rahbar, A., &amp; Gharlipour, Z. (2017). Nutritional preventive behavior of osteoporosis in female students: Applying health belief model (HBM). International Journal of Pediatrics, 5(37). https://doi.org/10.22038/ijp.2016.7560</citation>
    </reference>
    <reference>
      <citation>Kılıç, D., &amp; Erci, B. (2010). The reliability and validity of the osteoporosis health belief scale, osteoporosis self-efficacy scale and osteoporosis knowledge test. Journal of Anatolia Nursing and Health Sciences, 7(2), 89-102. https://dergipark.org.tr/en/pub/ataunihem/issue/2627/33798</citation>
    </reference>
    <reference>
      <citation>Kim, K., Horan, M., &amp; Gendler, P. (1991). Osteoporosis Knowledge Test, Osteoporosis Health Belief Scale, and Osteoporosis Self-efficacy Scale Allendale: MI: Grand Valley State University; Allendale. Masterson R. A descript.</citation>
    </reference>
    <reference>
      <citation>Kline J, Tang A, Levin B. Smoking, alcohol and caffeine in relation to two hormonal indicators of ovarian age during the reproductive years. Maturitas. 2016 Oct;92:115-122. doi: 10.1016/j.maturitas.2016.07.010. Epub 2016 Jul 21.</citation>
      <PMID>27621248</PMID>
    </reference>
    <reference>
      <citation>Majumdar SR, Lier DA, McAlister FA, Johnson JA, Rowe BH, Beaupre LA. Cost-Effectiveness of Osteoporosis Interventions to Improve Quality of Care After Upper Extremity Fracture: Results From a Randomized Trial (C-STOP Trial). J Bone Miner Res. 2019 Jul;34(7):1220-1228. doi: 10.1002/jbmr.3699. Epub 2019 Mar 18.</citation>
      <PMID>30779861</PMID>
    </reference>
    <reference>
      <citation>Oka R, Ohira M, Suzuki S, Yoshida T, Koide H, Tanaka T, Tatsuno I. Fracture risk assessment tool (FRAX) and for the diagnosis of osteoporosis in Japanese middle-aged and elderly women: Chiba bone survey. Endocr J. 2018 Feb 26;65(2):193-202. doi: 10.1507/endocrj.EJ17-0331. Epub 2017 Nov 18.</citation>
      <PMID>29151451</PMID>
    </reference>
    <reference>
      <citation>Pouresmaeili F, Kamalidehghan B, Kamarehei M, Goh YM. A comprehensive overview on osteoporosis and its risk factors. Ther Clin Risk Manag. 2018 Nov 6;14:2029-2049. doi: 10.2147/TCRM.S138000. eCollection 2018.</citation>
      <PMID>30464484</PMID>
    </reference>
    <reference>
      <citation>Qi BB, Resnick B, Smeltzer SC, Bausell B. Self-efficacy program to prevent osteoporosis among Chinese immigrants: a randomized controlled trial. Nurs Res. 2011 Nov-Dec;60(6):393-404. doi: 10.1097/NNR.0b013e3182337dc3.</citation>
      <PMID>22048557</PMID>
    </reference>
    <reference>
      <citation>Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.</citation>
      <PMID>21058606</PMID>
    </reference>
    <reference>
      <citation>TC. Sağlık Bakanlığı Halk Sağlığı Kurumu. (2016). Türkiye Beslenme Rehberi 2015 (TÜBER). T.C. Sağlık Bakanlığı Yayın No: 1031. Ankara.</citation>
    </reference>
    <reference>
      <citation>Ficek K, Rajca J, Cholewinski J, Racut A, Gwiazdon P, Przednowek K, Hajduk G. Analysis of intercondylar notch size and shape in patients with cyclops syndrome after anterior cruciate ligament reconstruction. J Orthop Surg Res. 2021 Sep 8;16(1):554. doi: 10.1186/s13018-021-02706-w.</citation>
      <PMID>34496898</PMID>
    </reference>
    <reference>
      <citation>Si M, Su X, Jiang Y, Wang W, Zhang X, Gu X, Ma L, Li J, Zhang S, Ren Z, Liu Y, Qiao Y. Effect of an IMB Model-Based Education on the Acceptability of HPV Vaccination Among College Girls in Mainland China: A Cluster RCT. Cancer Control. 2022 Jan-Dec;29:10732748211070719. doi: 10.1177/10732748211070719.</citation>
      <PMID>35088609</PMID>
    </reference>
    <reference>
      <citation>Tsamlag L, Wang H, Shen Q, Shi Y, Zhang S, Chang R, Liu X, Shen T, Cai Y. Applying the information-motivation-behavioral model to explore the influencing factors of self-management behavior among osteoporosis patients. BMC Public Health. 2020 Feb 6;20(1):198. doi: 10.1186/s12889-020-8292-x.</citation>
      <PMID>32028930</PMID>
    </reference>
    <reference>
      <citation>Tuzun S, Eskiyurt N, Akarirmak U, Saridogan M, Senocak M, Johansson H, Kanis JA; Turkish Osteoporosis Society. Incidence of hip fracture and prevalence of osteoporosis in Turkey: the FRACTURK study. Osteoporos Int. 2012 Mar;23(3):949-55. doi: 10.1007/s00198-011-1655-5. Epub 2011 May 19.</citation>
      <PMID>21594756</PMID>
    </reference>
    <reference>
      <citation>Upadhyaya GK, Iyengar K, Jain VK, Vaishya R. Challenges and strategies in management of osteoporosis and fragility fracture care during COVID-19 pandemic. J Orthop. 2020 Jun 2;21:287-290. doi: 10.1016/j.jor.2020.06.001. eCollection 2020 Sep-Oct. Erratum In: J Orthop. 2020 Dec 15;24:292.</citation>
      <PMID>32523258</PMID>
    </reference>
    <reference>
      <citation>World Health Organization (WHO). A healthy lifestyle-WHO recommendations (2023). Retrieved from: https://www.who.int/europe/news-room/fact-sheets/item/a-healthy-lifestyle---who-recommendations</citation>
    </reference>
    <reference>
      <citation>Yekefallah, L., Dehghankar, L., Aliakbari, M., &amp; Mafi, M. (2019). Lifestyle and preventive behaviors of osteoporosis among women of reproductive age in Qazvin-Iran: A cross sectional study. Social Health and Behavior, 2(2), 70. https://doi.org/10.4103/SHB.SHB_50_18</citation>
    </reference>
    <results_reference>
      <citation>Abay H, Kaplan S. Evaluation of the effectiveness of a training program for coping with PMS symptoms based on IMB model in university students. Women Health. 2021 Jul;61(6):550-561. doi: 10.1080/03630242.2021.1927286. Epub 2021 Jun 1.</citation>
      <PMID>34074223</PMID>
    </results_reference>
    <results_reference>
      <citation>Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.</citation>
      <PMID>1594721</PMID>
    </results_reference>
    <results_reference>
      <citation>Hong SY, Jun SY. Community Capacity Building Exercise Maintenance Program for Frail Elderly Women. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Sep;11(3):166-173. doi: 10.1016/j.anr.2017.06.001. Epub 2017 Aug 10.</citation>
      <PMID>28991596</PMID>
    </results_reference>
    <results_reference>
      <citation>Kim, Y. il, &amp; Park, J. S. (2017). Development and evaluation of a joint health self-management program for the elderly with knee osteoarthritis in communities: applying the IMB model. Research in Community and Public Health Nursing, 28(1), 55-68. https://doi.org/10.12799/JKACHN.2017.28.1.55</citation>
    </results_reference>
    <results_reference>
      <citation>Lee Y, Kim DH. A preliminary study on the effects of an osteoporosis prevention program based on an Information-Motivation-Behavioral skill model in older adult women: A cluster randomized controlled trial. Geriatr Nurs. 2022 May-Jun;45:55-63. doi: 10.1016/j.gerinurse.2022.03.001. Epub 2022 Mar 22.</citation>
      <PMID>35334422</PMID>
    </results_reference>
    <results_reference>
      <citation>Morton, M., &amp; Montgomery, P. (2011). Youth empowerment programs for improving self-efficacy and self-esteem of adolescents. Campbell Systematic Reviews, 7(1), 1-80. https://doi.org/10.4073/CSR.2011.5</citation>
    </results_reference>
    <results_reference>
      <citation>Panahi R, Siboni FS, Kheiri M, Ghoozlu KJ, Shafaei M, Dehghankar L. Promoting the adoption of behaviors to prevent osteoporosis using the health belief model integrated with health literacy: quasi-experimental intervention study. BMC Public Health. 2021 Dec 7;21(1):2221. doi: 10.1186/s12889-021-12300-8.</citation>
      <PMID>34872550</PMID>
    </results_reference>
    <results_reference>
      <citation>Park SJ, Jung JH, Kim MS, Lee HJ. High dairy products intake reduces osteoporosis risk in Korean postmenopausal women: A 4 year follow-up study. Nutr Res Pract. 2018 Oct;12(5):436-442. doi: 10.4162/nrp.2018.12.5.436. Epub 2018 Oct 1.</citation>
      <PMID>30323911</PMID>
    </results_reference>
    <results_reference>
      <citation>Shawashi, T. O., &amp; Darawad, M. (2020). Osteoporosis knowledge, beliefs and self-efficacy among female university students: a descriptive study. The Open Nursing Journal, 14(1), 211-219. https://doi.org/10.2174/1874434602014010211</citation>
    </results_reference>
    <results_reference>
      <citation>Shell DF, Newman IM, Perry CM, Folsom AR. Changing intentions to use smokeless tobacco: an application of the IMB model. Am J Health Behav. 2011 Sep;35(5):568-80. doi: 10.5993/ajhb.35.5.6.</citation>
      <PMID>22040618</PMID>
    </results_reference>
    <results_reference>
      <citation>Tastekin Ouyaba A, Ozyurek P, Sevil U. The effect of an information, motivation, and behavioral skills model intervention on young women's intention to get an HPV vaccine. Psychol Health Med. 2023 Mar;28(3):732-742. doi: 10.1080/13548506.2021.1975780. Epub 2021 Sep 5.</citation>
      <PMID>34486461</PMID>
    </results_reference>
    <results_reference>
      <citation>Yeager DS, Dahl RE, Dweck CS. Why Interventions to Influence Adolescent Behavior Often Fail but Could Succeed. Perspect Psychol Sci. 2018 Jan;13(1):101-122. doi: 10.1177/1745691617722620. Epub 2017 Dec 12.</citation>
      <PMID>29232535</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara Yildirim Beyazıt University</investigator_affiliation>
      <investigator_full_name>Sibel Peksoy Kaya</investigator_full_name>
      <investigator_title>Asst. Prof.</investigator_title>
    </responsible_party>
    <keyword>Osteoporosis</keyword>
    <keyword>Health Behaviors</keyword>
    <keyword>Health Beliefs</keyword>
    <keyword>Motivation</keyword>
    <keyword>Physical Activity</keyword>
    <keyword>Program Planning</keyword>
    <keyword>Self-Efficacy</keyword>
    <keyword>Health Information</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoporosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 30, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT06028243/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06028243
  org study id: 2021-12
  nct id: NCT06028243
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study investigated the effectiveness of a Healthy Living Awareness Program for the
        Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model
        (HLAPPO-IMB) in university students. The study adopted a randomized controlled trial
        intervention pretest, posttest, and follow-up research design. Participants were randomized
        into intervention (n=43) and control groups (n=44). Data were collected using a personal
        information form, the Osteoporosis Knowledge Test, the Osteoporosis Health Belief Scale, the
        Osteoporosis Self-Effective Scale, and the International Physical Activity Questionnaire
        Short Form.
  
        The primary outcome measure was the participants' knowledge and health beliefs about
        osteoporosis. The secondary outcome measure was the participants' healthy lifestyle behavior
        skills (self-efficacy in weight-bearing exercises, taking calcium, and engaging in physical
        activity).
  
        Research questions (RQ) RQ1: Does "Healthy Living Awareness Program for the Prevention of
        Osteoporosis based on the Information-Motivation-Behavioral Skills Model" expand
        participants' knowledge of osteoporosis? RQ2: Does "Healthy Living Awareness Program for the
        Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model"
        enhance participants' health beliefs? RQ3: Does "Healthy Living Awareness Program for the
        Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model"
        improve participants' self-efficacy in doing weight-bearing exercises and taking calcium?
        RQ4: Does "Healthy Living Awareness Program for the Prevention of Osteoporosis based on the
        Information-Motivation-Behavioral Skills Model" improve participants' self-efficacy in
        engaging in physical activity?
  This study adopted a randomized controlled trial pretest, posttest, and follow-up research
        design. The study was conducted between March and August 2021 at a public university in
        Türkiye. The study adhered to the CONSORT (Consolidated Standards of Reporting Trials)
        guidelines. Participants were randomized into intervention and control groups. Eligible
        students were randomized to intervention group or control group using block randomization
        technique. Blinding in the study was not feasible. Blinding could not be performed because
        the researchers were aware of the interventions and carried out the implementation. The
        intervention group attended the HLAPPO-IMB, which had three stages: information, motivation,
        and behavioral skills development. The control group did not undergo the intervention.
  
        The study population consisted of 125 fifth-semester nursing students in the fall term of the
        2020-2021 academic year. The undergraduate nursing programs in Türkiye are eight-semester
        programs. The mean Osteoporosis Knowledge Test (OKT) scores were used to determine the sample
        size. Power analyses were performed based on the difference between two independent means by
        G*Power 3.1.9.7. A power analysis was performed to determine the sample size in line with the
        literature [OKT: experimental group X̅±SD: 18.95±4.98 and control group X̅±SD: 15.18±3.88].
        The results showed that a sample of 76 would be large enough to detect significant
        differences (0.84 effect size, 0.05 level of error, and 95% power). All students who met the
        inclusion criteria were recruited to avoid missing data. The first sample consisted of 87
        participants, who were randomized to intervention (n=43) and control (n=44) groups. However,
        one student from the intervention group declined to participate. Therefore, the final sample
        consisted of 86 participants.
  
        The data were collected using a personal information form, the Osteoporosis Knowledge Test
        (OKT), the Osteoporosis Health Belief Scale (OHSB), the Osteoporosis Self-Effective Scale
        (OSES), and the International Physical Activity Questionnaire Short Form (IPAQ-SF).
  
        The personal information form: This form was prepared by the researchers. The form consisted
        of 30 items on sociodemographic characteristics and factors that might affect bone mineral
        density. Each participant's BMI, body weight, and body height were calculated based on
        his/her self-report.
  
        Osteoporosis knowledge test: The instrument consists of 24 items. The total score ranges from
        0 to 24, with higher scores indicating more osteoporosis-related knowledge.
  
        Osteoporosis health belief scale: The instrument consists of 42 items rated on a Likert-type
        scale. The total score ranges from 42 to 210, with higher scores indicating more positive
        health beliefs about osteoporosis.
  
        Osteoporosis self-effective scale: The scale consists of 12 items and two subscales: The
        Osteoporosis Self-Efficacy Exercise Scale (six items: starting an exercise program, changing
        exercise habits, doing appropriate exercise, etc.) and the Osteoporosis Self-Efficacy Calcium
        Scale (six items: increasing calcium intake, choosing calcium-rich foods, maintaining dietary
        calcium intake, etc.). The total score of each subscale ranges from 0 to 600. The total score
        ranges from 0 to 1200, with higher scores indicating better self-efficacy in weight-bearing
        exercises and taking calcium.
  
        International physical activity questionnaire short form: The form consists of seven items on
        physical activity. The total score is the "Metabolic Equivalent of Task minute/week (MET
        min/week)." The total score is calculated as "MET min/week" by multiplying the minute, day,
        and MET values. Physical activity levels are classified as low (<600 MET min/week), moderate
        (600-3000 MET min/week), or high (>3000 MET min/week) according to the total MET min/week
        values.
  
        Healthy life diary: The researchers developed the Healthy Life Diary to monitor the
        intervention group participants' healthy lifestyle behaviors to protect themselves from
        osteoporosis. The intervention group participants filled out the diary regularly and noted
        their daily calcium intake, type and duration of exercise, duration and time of sunlight
        exposure, and amount of tobacco, coffee, tea, cola, etc.
  
        Procedure: The data were collected online because of the COVID-19 pandemic. The researchers
        briefed students on the research procedure and texted them a link to the survey on WhatsApp.
        The first page of the survey was a consent form. After obtaining informed consent, the
        researchers directed all students who agreed to participate to the inclusion criteria
        section. Students are a vulnerable population. Thus, the researchers took measures to ensure
        students would not feel coerced to participate. The researchers informed all students about
        the research purpose and procedure. Participation was voluntary. The researchers kept all
        personal information confidential. All participants had pseudonyms.
  
        Healthy living awareness program for the prevention of osteoporosis: The intervention group
        participants underwent the Healthy Living Awareness Program for the Prevention of
        Osteoporosis (HLAPPO-IMB) in three stages based on IMB.
  
        Information stage: The researchers provided the intervention group participants with online
        training in healthy living awareness to prevent osteoporosis (400 minutes and two days). They
        held the training at all participants' convenience outside the class hours. The training
        consisted of four sections: osteoporosis and diagnosis-treatment methods, current approaches
        to the prevention of osteoporosis, osteoporosis and nutrition, and osteoporosis and physical
        exercise. The researchers employed interactive teaching methods and consulted three experts
        to prepare PowerPoint presentations. At the end of the training, the researchers taught the
        intervention group participants how to fill out the healthy life diary, such as calculating
        daily calcium intake. The researchers texted the intervention group participants all training
        videos on WhatsApp to allow them to watch them again. All participants filled out the OKT and
        OHSB (posttest) two and three weeks after the training. They filled them out again two months
        after the posttest (follow-up).
  
        Motivation stage: The researchers regularly texted (WhatsApp) spot and reminder notifications
        concerning the prevention of osteoporosis. They asked them to assess the health behaviors
        they recorded in their diaries every week (daily calcium intake, weekly exercise duration,
        etc.) and the problems they experienced during the process. The researchers provided
        individual counseling to the participants by telephone (combating smoking, exercise barriers,
        food exchange for calcium sources, etc.)
  
        Behavior skills stage: The target behavior skills were improved self-efficacy in doing
        weight-bearing exercises, taking calcium, and engaging in physical activity. The OSES was
        used to assess participants' self-efficacy to initiate and maintain behavior related to
        exercise and calcium taking, while the IPAQ-SF was used to assess their physical activity
        levels.
  
        Data analysis: The data were analyzed using the Statistical Package for Social Sciences.
        Percentage, mean, and standard deviation were used for descriptive analysis. The categorical
        variables were analyzed using the Pearson, Fisher χ2, and Marginal Homogeneity tests. The
        Mann-Whitney U test was used to compare two independent groups. The Wilcoxon Signed Rank test
        or Friedman nonparametric test was used for dependent measurement comparisons. The effect
        size (r or Kendall W) was calculated for each comparison. The following limit values were
        accepted for the interpretation of the effect sizes: r < 0.29 "small effect," r=0.30-0.49
        "medium effect," r ≥ 0.50 "large effect." W effect size: <0.39 "small effect," 0.40-0.59
        "medium effect,"≥ 0.60 "large effect". The Mann-Whitney U Test was used to compare the
        difference in age, menarche age, BMI, and scale scores between the groups. The Wilcoxon
        Signed Rank test was used to compare the pretest and posttest scores. Friedman test was used
        for repeated measures for dependent groups. Dunn's Bonferroni correction was used to
        determine the source of the difference.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  masking description: Blinding in the study was not feasible. Blinding could not be performed because the researchers were aware of the interventions and carried out the implementation.
  measure: The effect of the program on the primary outcome-1 (Osteoporosis Knowledge Test)
  time frame: Pretest: 3 weeks, Completion of training: 2 weeks, Posttest: 2 weeks (2-3 weeks after training), Follow-up: 2 weeks (2 months after posttest). Total period of research: 20 weeks. Total application time of this scale: 7weeks.
  description: Osteoporosis Knowledge Test consists of 24 items. The total score ranges from 0 to 24, with higher scores indicating more osteoporosis-related knowledge.
  Osteoporosis Knowledge Test with Osteoporosis Health Belief Scale was applied three times (pretest, posttest and follow-up) to the intervention and control groups. Training was given to the intervention group after completing the Osteoporosis Knowledge Test (with other scales) as a pretest. After the training, it was applied to the participants as a posttest and follow-up. All participants filled out the Osteoporosis Knowledge Test with Osteoporosis Health Belief Scale (posttest) two and three weeks after the training. They filled them out again two months after the posttest (follow-up).
  In the study protocol, pretest postest and follow up times are given in detail.
  measure: The effect of the program on the primary outcome-2 (Osteoporosis Health Belief Scale)
  time frame: Pretest: 3 weeks, Completion of training: 2 weeks, Posttest: 2 weeks (2-3 weeks after training), Follow-up: 2 weeks (2 months after posttest). Total period of research: 20 weeks. Total application time of this scale: 7weeks.
  description: Osteoporosis Health Belief Scale consists of 42 items rated on a Likert-type scale. The total score ranges from 42 to 210, with higher scores indicating more positive health beliefs about osteoporosis.
  Osteoporosis Health Belief Scale with Osteoporosis Knowledge Test was applied three times (pretest, posttest and follow-up) to the intervention and control groups. Training was given to the intervention group after completing the Osteoporosis Health Belief Scale (with other scales) as a pretest. After the training, it was applied to the participants as a posttest and follow-up. All participants filled out the Osteoporosis Health Belief Scale with Osteoporosis Knowledge Test (posttest) two and three weeks after the training. They filled them out again two months after the posttest (follow-up).
  measure: The effect of the program on the secondary outcome-1 (Osteoporosis Self-Effective Scale)
  time frame: Pretest: 3 weeks, training and follow-up period: 15 weeks, Follow-up: 2 weeks. Total period of research: 20 weeks. Total application time of this scale: 5 weeks.
  description: Osteoporosis Self-Effective Scale consists of 12 items and two subscales: The Osteoporosis Self-Efficacy Exercise Scale (six items: starting an exercise program, changing exercise habits, doing appropriate exercise, etc.) and the Osteoporosis Self-Efficacy Calcium Scale (six items: increasing calcium intake, choosing calcium-rich foods, maintaining dietary calcium intake, etc.). The total score of each subscale ranges from 0 to 600. The total score ranges from 0 to 1200, with higher scores indicating better self-efficacy in weight-bearing exercises and taking calcium.
  Osteoporosis Self-Effective Scale was applied twice (pretest and follow-up) with International Physical Activity Questionnaire Short Form to the study groups. It was applied as a pretest with other scales. It was applied as a follow-up 13 weeks after the training.
  measure: The effect of the program on the primary outcome-2 (International Physical Activity Questionnaire Short Form)
  time frame: Pretest: 3 weeks, training and follow-up period: 15 weeks, Follow-up: 2 weeks. Total period of research: 20 weeks. Total application time of this scale: 5 weeks.
  description: International Physical Activity Questionnaire Short Form consists of seven items on physical activity. The total score is the "Metabolic Equivalent of Task minute/week)." The total score is calculated as "Metabolic Equivalent of Task minute/week " by multiplying the minute, day, and Metabolic Equivalent of Task values. Physical activity levels are classified as low, moderate, or high according to the total Metabolic Equivalent of Task min/week values. International Physical Activity Questionnaire Short Form was applied twice (pretest and follow-up) with Osteoporosis Self-Effective Scale to the study groups. It was applied as a pretest with other scales. It was applied as a follow-up 13 weeks after the training.
  arm group label: Intervention Group
  arm group type: Experimental
  description: The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB) was implemented in three stages.
  Information stage: The researchers provided the intervention group participants with online training in healthy living awareness to prevent osteoporosis. The training consisted of four sections: osteoporosis and diagnosis-treatment methods, current approaches to the prevention of osteoporosis, osteoporosis and nutrition, and osteoporosis and physical exercise. At the end of the training, the participants were informed about the healthy life diary and record.
  Motivation stage: The researchers regularly texted reminder notifications concerning the prevention of osteoporosis. The records in their diaries were reviewed. The researchers provided individual counseling to the participants by telephone.
  Behavior skills stage: The target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity.
  arm group label: Control Group
  arm group type: No Intervention
  description: The control group was not trained. Data collection forms applied to the intervention group were also applied to the control group simultaneously.
  intervention type: Other
  intervention name: The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stage
  description: The researchers provided the intervention group participants with online training in healthy living awareness to prevent osteoporosis (400 minutes and two days). They held the training at all participants' convenience outside the class hours. The training consisted of four sections: (1) osteoporosis and diagnosis-treatment methods, (2) current approaches to the prevention of osteoporosis, (3) osteoporosis and nutrition, and (4) osteoporosis and physical exercise. The researchers employed interactive teaching methods and consulted three experts to prepare PowerPoint presentations. At the end of the training, the researchers taught the intervention group participants how to fill out the healthy life diary, such as calculating daily calcium intake. The researchers texted the intervention group participants all training videos on WhatsApp to allow them to watch them again.
  arm group label: Intervention Group
  intervention type: Other
  intervention name: The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stage
  description: The researchers regularly texted (WhatsApp) spot and reminder notifications concerning the prevention of osteoporosis. They asked them to assess the health behaviors they recorded in their diaries every week (daily calcium intake, weekly exercise duration, etc.) and the problems they experienced during the process. The researchers provided individual counseling to the participants by telephone (combating smoking, exercise barriers, food exchange for calcium sources, etc.)
  arm group label: Intervention Group
  intervention type: Behavioral
  intervention name: The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stage
  description: The target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 26 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: SİBEL PEKSOY KAYA, Asst. Prof.
  role: Principal Investigator
  affiliation: ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY
  last name: SENA KAPLAN, Prof. Dr.
  role: Study Director
  affiliation: ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY
  last name: ESRA BAŞKAYA, Dr.
  role: Study Director
  affiliation: ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY
  facility: 
  country: Turkey
  citation: Aktas O, Kaplan S, Sezer N. An assessment of the relation between bone mineral density and clinic-demographic properties and life quality during postmenopausal period. J Back Musculoskelet Rehabil. 2018;31(5):803-810. doi: 10.3233/BMR-170933.
  PMID: 29865030
  citation: Alpar, R. (2022). Spor Sağlık ve Eğitim Bilimlerinden Örneklerle Uygulamalı İstatistik ve Geçerlik Güvenirlik; (7th edition). Ankara: Detay Yayıncılık.
  citation: Bahrami Z, Zarani F. Application of the Information-Motivation and Behavioral Skills (IMB) model in risky sexual behaviors amongst male students. J Infect Public Health. 2015 Mar-Apr;8(2):207-13. doi: 10.1016/j.jiph.2014.09.005. Epub 2014 Nov 22.
  PMID: 25466597
  citation: Barley E, Lawson V. Using health psychology to help patients: theories of behaviour change. Br J Nurs. 2016 Sep 8;25(16):924-7. doi: 10.12968/bjon.2016.25.16.924.
  PMID: 27615529
  citation: Bonjour JP, Theintz G, Law F, Slosman D, Rizzoli R. Peak bone mass. Osteoporos Int. 1994;4 Suppl 1:7-13. doi: 10.1007/BF01623429.
  PMID: 8081064
  citation: Bonjour, P., Compston, J., Dawson-Hughes, B., Delmas, P., Lyon, H. E. H., Ms, F., Johansson, H., Kanis, J. A., Lau, E., Yuen, L., Centre, H., Kong, H., Dr, C., Lindsay, R., Mcclung, M. R., Oden, A., Pfleger, B., Teilen, M. G., Clark Hospital De Especialidades, P., … Toroptsova, N. (2007). Assessment of Osteoporosis at The Primary Health Care Level. www.who.int/chp/topics/rheumatic/en/index.html
  citation: Cooper, C., & Ferrari, S. (2019). IOF Compendium of Osteoporosis (2nd Edition). Switzerland: International Osteoporosis Foundation.
  citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
  PMID: 12900694
  citation: EQUATOR guidelines. (2020). Checklist for reporting a randomised trial. Retrieved from: https://www.goodreports.org/reporting-checklists/consort/
  citation: Haleem A, Javaid M, Vaishya R. Effects of COVID-19 pandemic in daily life. Curr Med Res Pract. 2020 Mar-Apr;10(2):78-79. doi: 10.1016/j.cmrp.2020.03.011. Epub 2020 Apr 3. No abstract available.
  PMID: 32292804
  citation: Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos. 2013;8(1):136. doi: 10.1007/s11657-013-0136-1. Epub 2013 Oct 11.
  PMID: 24113837
  citation: Hosseini, Z., Karimi, Z., Mohebi, S., Reza Sharifirad, G., Rahbar, A., & Gharlipour, Z. (2017). Nutritional preventive behavior of osteoporosis in female students: Applying health belief model (HBM). International Journal of Pediatrics, 5(37). https://doi.org/10.22038/ijp.2016.7560
  citation: Kılıç, D., & Erci, B. (2010). The reliability and validity of the osteoporosis health belief scale, osteoporosis self-efficacy scale and osteoporosis knowledge test. Journal of Anatolia Nursing and Health Sciences, 7(2), 89-102. https://dergipark.org.tr/en/pub/ataunihem/issue/2627/33798
  citation: Kim, K., Horan, M., & Gendler, P. (1991). Osteoporosis Knowledge Test, Osteoporosis Health Belief Scale, and Osteoporosis Self-efficacy Scale Allendale: MI: Grand Valley State University; Allendale. Masterson R. A descript.
  citation: Kline J, Tang A, Levin B. Smoking, alcohol and caffeine in relation to two hormonal indicators of ovarian age during the reproductive years. Maturitas. 2016 Oct;92:115-122. doi: 10.1016/j.maturitas.2016.07.010. Epub 2016 Jul 21.
  PMID: 27621248
  citation: Majumdar SR, Lier DA, McAlister FA, Johnson JA, Rowe BH, Beaupre LA. Cost-Effectiveness of Osteoporosis Interventions to Improve Quality of Care After Upper Extremity Fracture: Results From a Randomized Trial (C-STOP Trial). J Bone Miner Res. 2019 Jul;34(7):1220-1228. doi: 10.1002/jbmr.3699. Epub 2019 Mar 18.
  PMID: 30779861
  citation: Oka R, Ohira M, Suzuki S, Yoshida T, Koide H, Tanaka T, Tatsuno I. Fracture risk assessment tool (FRAX) and for the diagnosis of osteoporosis in Japanese middle-aged and elderly women: Chiba bone survey. Endocr J. 2018 Feb 26;65(2):193-202. doi: 10.1507/endocrj.EJ17-0331. Epub 2017 Nov 18.
  PMID: 29151451
  citation: Pouresmaeili F, Kamalidehghan B, Kamarehei M, Goh YM. A comprehensive overview on osteoporosis and its risk factors. Ther Clin Risk Manag. 2018 Nov 6;14:2029-2049. doi: 10.2147/TCRM.S138000. eCollection 2018.
  PMID: 30464484
  citation: Qi BB, Resnick B, Smeltzer SC, Bausell B. Self-efficacy program to prevent osteoporosis among Chinese immigrants: a randomized controlled trial. Nurs Res. 2011 Nov-Dec;60(6):393-404. doi: 10.1097/NNR.0b013e3182337dc3.
  PMID: 22048557
  citation: Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
  PMID: 21058606
  citation: TC. Sağlık Bakanlığı Halk Sağlığı Kurumu. (2016). Türkiye Beslenme Rehberi 2015 (TÜBER). T.C. Sağlık Bakanlığı Yayın No: 1031. Ankara.
  citation: Ficek K, Rajca J, Cholewinski J, Racut A, Gwiazdon P, Przednowek K, Hajduk G. Analysis of intercondylar notch size and shape in patients with cyclops syndrome after anterior cruciate ligament reconstruction. J Orthop Surg Res. 2021 Sep 8;16(1):554. doi: 10.1186/s13018-021-02706-w.
  PMID: 34496898
  citation: Si M, Su X, Jiang Y, Wang W, Zhang X, Gu X, Ma L, Li J, Zhang S, Ren Z, Liu Y, Qiao Y. Effect of an IMB Model-Based Education on the Acceptability of HPV Vaccination Among College Girls in Mainland China: A Cluster RCT. Cancer Control. 2022 Jan-Dec;29:10732748211070719. doi: 10.1177/10732748211070719.
  PMID: 35088609
  citation: Tsamlag L, Wang H, Shen Q, Shi Y, Zhang S, Chang R, Liu X, Shen T, Cai Y. Applying the information-motivation-behavioral model to explore the influencing factors of self-management behavior among osteoporosis patients. BMC Public Health. 2020 Feb 6;20(1):198. doi: 10.1186/s12889-020-8292-x.
  PMID: 32028930
  citation: Tuzun S, Eskiyurt N, Akarirmak U, Saridogan M, Senocak M, Johansson H, Kanis JA; Turkish Osteoporosis Society. Incidence of hip fracture and prevalence of osteoporosis in Turkey: the FRACTURK study. Osteoporos Int. 2012 Mar;23(3):949-55. doi: 10.1007/s00198-011-1655-5. Epub 2011 May 19.
  PMID: 21594756
  citation: Upadhyaya GK, Iyengar K, Jain VK, Vaishya R. Challenges and strategies in management of osteoporosis and fragility fracture care during COVID-19 pandemic. J Orthop. 2020 Jun 2;21:287-290. doi: 10.1016/j.jor.2020.06.001. eCollection 2020 Sep-Oct. Erratum In: J Orthop. 2020 Dec 15;24:292.
  PMID: 32523258
  citation: World Health Organization (WHO). A healthy lifestyle-WHO recommendations (2023). Retrieved from: https://www.who.int/europe/news-room/fact-sheets/item/a-healthy-lifestyle---who-recommendations
  citation: Yekefallah, L., Dehghankar, L., Aliakbari, M., & Mafi, M. (2019). Lifestyle and preventive behaviors of osteoporosis among women of reproductive age in Qazvin-Iran: A cross sectional study. Social Health and Behavior, 2(2), 70. https://doi.org/10.4103/SHB.SHB_50_18
  citation: Abay H, Kaplan S. Evaluation of the effectiveness of a training program for coping with PMS symptoms based on IMB model in university students. Women Health. 2021 Jul;61(6):550-561. doi: 10.1080/03630242.2021.1927286. Epub 2021 Jun 1.
  PMID: 34074223
  citation: Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
  PMID: 1594721
  citation: Hong SY, Jun SY. Community Capacity Building Exercise Maintenance Program for Frail Elderly Women. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Sep;11(3):166-173. doi: 10.1016/j.anr.2017.06.001. Epub 2017 Aug 10.
  PMID: 28991596
  citation: Kim, Y. il, & Park, J. S. (2017). Development and evaluation of a joint health self-management program for the elderly with knee osteoarthritis in communities: applying the IMB model. Research in Community and Public Health Nursing, 28(1), 55-68. https://doi.org/10.12799/JKACHN.2017.28.1.55
  citation: Lee Y, Kim DH. A preliminary study on the effects of an osteoporosis prevention program based on an Information-Motivation-Behavioral skill model in older adult women: A cluster randomized controlled trial. Geriatr Nurs. 2022 May-Jun;45:55-63. doi: 10.1016/j.gerinurse.2022.03.001. Epub 2022 Mar 22.
  PMID: 35334422
  citation: Morton, M., & Montgomery, P. (2011). Youth empowerment programs for improving self-efficacy and self-esteem of adolescents. Campbell Systematic Reviews, 7(1), 1-80. https://doi.org/10.4073/CSR.2011.5
  citation: Panahi R, Siboni FS, Kheiri M, Ghoozlu KJ, Shafaei M, Dehghankar L. Promoting the adoption of behaviors to prevent osteoporosis using the health belief model integrated with health literacy: quasi-experimental intervention study. BMC Public Health. 2021 Dec 7;21(1):2221. doi: 10.1186/s12889-021-12300-8.
  PMID: 34872550
  citation: Park SJ, Jung JH, Kim MS, Lee HJ. High dairy products intake reduces osteoporosis risk in Korean postmenopausal women: A 4 year follow-up study. Nutr Res Pract. 2018 Oct;12(5):436-442. doi: 10.4162/nrp.2018.12.5.436. Epub 2018 Oct 1.
  PMID: 30323911
  citation: Shawashi, T. O., & Darawad, M. (2020). Osteoporosis knowledge, beliefs and self-efficacy among female university students: a descriptive study. The Open Nursing Journal, 14(1), 211-219. https://doi.org/10.2174/1874434602014010211
  citation: Shell DF, Newman IM, Perry CM, Folsom AR. Changing intentions to use smokeless tobacco: an application of the IMB model. Am J Health Behav. 2011 Sep;35(5):568-80. doi: 10.5993/ajhb.35.5.6.
  PMID: 22040618
  citation: Tastekin Ouyaba A, Ozyurek P, Sevil U. The effect of an information, motivation, and behavioral skills model intervention on young women's intention to get an HPV vaccine. Psychol Health Med. 2023 Mar;28(3):732-742. doi: 10.1080/13548506.2021.1975780. Epub 2021 Sep 5.
  PMID: 34486461
  citation: Yeager DS, Dahl RE, Dweck CS. Why Interventions to Influence Adolescent Behavior Often Fail but Could Succeed. Perspect Psychol Sci. 2018 Jan;13(1):101-122. doi: 10.1177/1745691617722620. Epub 2017 Dec 12.
  PMID: 29232535
  responsible party type: Principal Investigator
  investigator affiliation: Ankara Yildirim Beyazıt University
  investigator full name: Sibel Peksoy Kaya
  investigator title: Asst. Prof.
  mesh term: Osteoporosis
  sharing ipd: No
  ipd description: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
  provided document: 