<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/NCT03253406</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000386</org_study_id>
    <nct_id>NCT03253406</nct_id>
  </id_info>
  <brief_title>Health Wearables and College Student Health</brief_title>
  <official_title>Use of Health Wearables to Improve Physical Activity and Eating Behaviors Among College Students: A 12-week Randomized Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this pilot randomized trial is to determine (1) the effectiveness of the Polar&#xD;
      M400, used in combination with a twice-weekly Facebook-delivered Social Cognitive&#xD;
      Theory-based health intervention, in the promotion of more healthful physical activity and&#xD;
      nutritious eating behaviors over 12 weeks in college students versus a comparison group; and&#xD;
      (2) the validity and reliability of the Polar M400 in the assessment of free-living (i.e.,&#xD;
      non-laboratory based) physical activity (in this case, steps per day and daily durations of&#xD;
      moderate and vigorous physical activity) and energy expenditure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of overweight and obesity among individuals 20-39 years of age is 60.9%.&#xD;
      Unfortunately, physical inactivity and poor dietary practices among this age cohort appear to&#xD;
      be two major contributory factors for the preceding statistic. Among the youngest individuals&#xD;
      within this age cohort are college students. Research suggests college students possess risk&#xD;
      factors for overweight and obesity as many of these individuals are now independent and, for&#xD;
      some, making physical activity- and nutrition-related decisions autonomously for the first&#xD;
      time. Studies on obesity- and weight-related behaviors in this population suggest&#xD;
      approximately 25% to 30% of college students are overweight or obese. Desai et al. also&#xD;
      suggested rates of complete physical inactivity among college students is between 37% and&#xD;
      46%. Unfortunately, dietary practices among college students are not ideal either.&#xD;
&#xD;
      Poor nutritional behaviors also contribute to risk factors among this population. In a study&#xD;
      among college freshman and sophomores, Racette, Deusinger, Strube, Highstein, and Deusinger&#xD;
      found that 70% of the 764 college students assessed consumed less than the U.S. Department of&#xD;
      Agriculture (USDA) recommendations of two servings of fruit and three servings of vegetables&#xD;
      daily. Strikingly, approximately half of the students surveyed also reported high-fat fast or&#xD;
      fried food consumption ≥ 3 times in the past week. Notably, a subsample of these students was&#xD;
      assessed again a year later with 70% of these students gaining, on average, four kilograms.&#xD;
      Indeed, other studies have demonstrated the impact poor dietary practices (e.g., consumption&#xD;
      of &quot;junk foods&quot;, sugar-sweetened beverages, or fast foods high in fat and low in nutrient&#xD;
      density) and obesogenic environments (e.g., continuously eating at buffet-style student&#xD;
      dining halls) can have on weight gain from freshman year of college onward. As such, not only&#xD;
      is it clear that theoretically-backed physical activity interventions are needed among&#xD;
      college students, there is also a distinct need to include a dietary component within these&#xD;
      interventions. Technology integration within these physical activity and nutritional&#xD;
      interventions among college students might present a viable approach.&#xD;
&#xD;
      While few empirical data is available regarding health wearable use among young adults, it is&#xD;
      likely that this technology-savvy age cohort represents a large proportion of the one in six&#xD;
      consumers currently owning a health wearable. Further, with the number of health wearables&#xD;
      sold in 2018 projected to be 110 million, it is likely that this age cohort will contribute&#xD;
      substantially to this figure. Moreover, research indicates the popularity of social media&#xD;
      among young adults. Indeed, among individuals 18-29 years of age, approximately 90% use at&#xD;
      least one social media site. Currently, Facebook represents the most widely used social media&#xD;
      site with 1.71 billion active users and individuals 18 to 34 years of age representing the&#xD;
      majority of Facebook users.&#xD;
&#xD;
      Therefore, the combined use of health wearable technology, these devices' associated&#xD;
      smartphone applications, and a theoretically-driven health intervention delivered via social&#xD;
      media, may prove appealing and effective as a health promotion strategy among college&#xD;
      students. Specifically, use of the Polar M400 may increase college students' ability to&#xD;
      self-regulate physical activity behaviors as self-regulation is posited as an important&#xD;
      factor in promoting behavior change. Further, the Polar M400's associated smartphone&#xD;
      application-based and Internet-based portal allows individuals to not only track physical&#xD;
      activity-related metrics, but view predicted energy expenditure as well, which may allow&#xD;
      individuals to self-regulate food intake in relation to daily energy expenditure. In&#xD;
      combination with the Polar M400's capabilities, a twice-weekly Facebook-delivered Social&#xD;
      Cognitive Theory-based health intervention may be able to increase college students'&#xD;
      self-efficacy, outcome expectancy, enjoyment, and social support while decreasing barriers&#xD;
      for participation in greater physical activity and nutritious eating behaviors. Relatedly, it&#xD;
      is vital to also examine the preceding intervention's ability to promote changes in college&#xD;
      students' intrinsic motivation for these health behaviors-an investigation which can be&#xD;
      completed via application of the Self-Determination Theory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">May 7, 2018</completion_date>
  <primary_completion_date type="Actual">May 4, 2018</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>
    <intervention_model_description>A two-arm randomized pilot trial design will be used, with one Experimental Group and one Comparison Group. A random numbers table will be used to randomize participants with a 1:1 allocation ratio.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Every attempt will be made to ensure participants do not know the group with which they have been randomized, accomplished by advertising to potential college student participants that two novel, technology-based interventions will be employed in the study, with no more detail provided. After screening and randomization, participants will be informed of study intervention procedures in an identical manner regardless of group allocation via the use of a study script repeated to each participant by the study's primary investigator. The only difference between the scripts will be a discussion with experimental group participants regarding how to use the Polar M400 smartwatch during the study intervention period. Importantly, college students will be brought into the Lab for screening and baseline testing on an individual basis ensuring the individuals from different groups have no idea of the differing intervention procedures utilized between the experimental and comparison groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>&quot;Change in Physical Activity from Baseline to 6 Weeks&quot; and &quot;Change in Physical Activity from Baseline to 12 Weeks&quot;</time_frame>
    <description>Will be assessed via Actigraph Link accelerometers with daily moderate-to-vigorous physical activity, light physical activity, sedentary behavior, steps per day, and energy expenditure the outcomes of interest. The Actigraph accelerometer has been validated among adults (Kaminsky &amp; Ozemek, 2012). Participants will wear the accelerometer for seven days (ensuring the collection of physical activity data on at least two weekdays and one weekend day) as suggested for field-based accelerometer research (Trost, McIver, &amp; Pate, 2005), with the accelerometer appended to the same wrist as the Polar M400. Accelerometry measurements will take place at baseline, six weeks, and 12 weeks to examine changes over time in the aforementioned outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Fitness</measure>
    <time_frame>&quot;Change in Cardiovascular Fitness from Baseline to 12 Weeks&quot;</time_frame>
    <description>Evaluated with YMCA 3-minute step test (Golding, Meyers, &amp; Sinning, 1998). Participants will step up and down for three minutes on a 12-inch riser to a metronome beep set at 96 beats per minute (each beep corresponding to one movement of the leg, with 4 beeps representing one &quot;up-down&quot; cycle). Participants' heart rate will be assessed immediately for one minute following the conclusion of the test by the researcher via palpation of the carotid/radial artery. The step test will be performed at baseline and 12 weeks to assess changes in cardiovascular fitness over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>&quot;Change in Body Composition from Baseline to 12 Weeks&quot;</time_frame>
    <description>Determined via bioelectrical impedance performed with the Tanita BC-558 IRONMAN® Segmental Body Composition Monitor (Tanita, Tokyo, Japan). Bioelectrical impedance sends a small electrical pulsatile wave through the body. Muscle is more conducive to electrical current transmission due to its higher water content versus fat meaning individuals with higher lean mass (i.e., lower body fat mass) will not impede the current to the degree of individuals with higher fat mass and therefore register lower body fat percentage values. Bioelectrical impedance has proven a valid measure of body composition in young adults enrolling in the military (Aandstad, Holtberget, Hageberg, Holme, &amp; Anderssen, 2014). Notably, to decrease variability in these body composition measurements, individuals will be asked to come in for testing at approximately the same time of day and having eaten/drank similar foods/beverages the night before as they did prior to previous session(s).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Weight</measure>
    <time_frame>&quot;Change in Weight from Baseline to 12 Weeks&quot;</time_frame>
    <description>Body Weight will be assessed using a calibrated weight scale: the Tanita BC-558 IRONMAN® Segmental Body Composition Monitor (Tanita, Tokyo, Japan).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy</measure>
    <time_frame>&quot;Change in Self-Efficacy from Baseline to 12 Weeks&quot;</time_frame>
    <description>Self-efficacy will be measured by a nine-question measure developed by Rodgers, Wilson, Hall, Fraser, and Murray (2008) wherein participants will rate how confident they feel in certain exercise situations (e.g., …&quot;exercise when you feel discomfort&quot; or &quot;…exercise when you lack energy&quot;) on a percentage scale (0%: not confident at all to 100%: extremely confident in 10% increments).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Support</measure>
    <time_frame>&quot;Change in Social Support from Baseline to 12 Weeks&quot;</time_frame>
    <description>Social support will be assessed using a five-question measure adapted from the Patient-Centered Assessment and Counseling for Exercise questionnaire, with participants rating on a five-point Likert-type scale (1: almost never to 5: almost always) how often significant others support/encourage them to be physically activity (Carlson et al., 2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment</measure>
    <time_frame>&quot;Change in Enjoyment from Baseline to 12 Weeks&quot;</time_frame>
    <description>A 5-question measure developed by Harter et al. (1978) quantified PA enjoyment as college students noted agreement with statements such as &quot;Engaging in physical activity is the thing I like to do best&quot; on a 5-point Likert-type scale (1: strongly disagree to 5: strongly agree).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers</measure>
    <time_frame>&quot;Change in Barriers from Baseline to 12 Weeks&quot;</time_frame>
    <description>A 14-question measure will evaluate participants' physical activity barriers, with participants asked to rate agreement between hypothetical barriers and their own barriers on a four-point Likert-type scale (1: strongly disagree to 4: strongly agree) (Sechrist, Walker, &amp; Pender, 1987).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome Expectancy</measure>
    <time_frame>&quot;Change in Outcome Expectancy from Baseline to 12 Weeks&quot;</time_frame>
    <description>Outcome expectancy will be assessed with a nine-question measure developed by Trost et al. (1997) using a five-point Likert-type scale (1: strongly disagree to 5: strongly agree) to evaluate participants' agreement with responses originating from the stem &quot;If I was to exercise on most days it would…&quot;. Sample responses are &quot;give me more energy&quot; and &quot;help to control my weight&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intrinsic Motivation</measure>
    <time_frame>&quot;Change in Intrinsic Motivation from Baseline to 12 Weeks&quot;</time_frame>
    <description>Will be evaluated using the interest/enjoyment subscale of the Intrinsic Motivation Inventory (McAuley, Duncan, &amp; Tammen, 1987). This seven-question subscale requires participants to determent how true certain statements such as &quot;I enjoyed this activity very much&quot; and &quot;I would describe this activity as interesting&quot; are to them on a seven-point Likert-type scale (1: not at all true to 7: very true). The Intrinsic Motivation Inventory has demonstrated good validity in the assessment of intrinsic motivation during exercise (Deci, Eghrari, Patrick, &amp; Leone, 1994).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritious Eating Behaviors</measure>
    <time_frame>&quot;Change in Nutritious Eating Behaviors from Baseline to 12 Weeks&quot;</time_frame>
    <description>To assess participant eating behaviors, the National Cancer Institute's Automated Self-Administered (ASA) 24-hour Dietary Recall will be used requiring participants to recall all foods consumed within the past 24 hours. The ASA 24-hour Dietary Recall has been validated in previous research (Kipnis et al., 2003; Moshfegh et al., 2008). Participants will receive unique login information allowing them to access and complete the recall after which the researcher will be able to download and analyze the results. The ASA 24-hour Dietary recall will be administered three times on random dates during the seven days following baseline and post-intervention testing at 12 weeks, with participants notified during these testing sessions that they will be asked to complete this questionnaire. Concentration will be placed on examining changes in participants' fruit and vegetable consumption in addition to the participants' intake of fast food and sugar-sweetened beverages.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facebook-Delivered Health Intervention Adherence</measure>
    <time_frame>&quot;Assessed Weekly throughout 12-Week Intervention Period&quot;</time_frame>
    <description>Regardless of group allocation, adherence to the social media-delivered health intervention previously outlined will be tracked. Briefly, the researcher will determine whether the participants have checked the Facebook health tips twice weekly in two manners following the alert each participant will receive when a new post goes live on each groups' Facebook page. First, Facebook now has a &quot;Seen By&quot; function that automatically indicates and lists everyone who has interacted with a new posting within a private Facebook group. Second, the researcher will also ask participants to &quot;Like&quot; each of the postings they read. In this way, the researcher will keep a running tally of whether each participant checked the posting by reviewing the &quot;Seen By&quot; function and whether the individual &quot;Liked&quot; the posting. Only individuals listed both within the &quot;Seen By&quot; function and as having &quot;Liked&quot; the posting will be counted as having seen the health tips.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Behavior Change</condition>
  <condition>Physical Activity</condition>
  <condition>Young Adults</condition>
  <condition>Technology</condition>
  <condition>Intervention</condition>
  <arm_group>
    <arm_group_label>Polar M400 + Facebook Group (PM400+FG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will be provided a Polar M400 to track physical activity and energy expenditure while also being included in a Facebook group wherein Social Cognitive Theory-based physical activity and nutritious eating tips will be provided twice weekly for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Facebook Only Group (FG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Included exclusively in a separate, but content-identical, Facebook group for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Polar M400 + Facebook Group (PM400+FG)</intervention_name>
    <description>Throughout the intervention period experimental group participants will be asked to read and try to implement the twice-weekly physical activity- and nutrition-related health tips posted to the group's Facebook page. Additionally, experimental group participants will be asked to track all physical activity with the Polar M400 smartwatch and use this information to set physical activity-related goals conducive to improved health.</description>
    <arm_group_label>Polar M400 + Facebook Group (PM400+FG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Facebook Only Group (FG)</intervention_name>
    <description>Throughout the intervention period comparison group participants will be asked to read and try to implement the twice-weekly physical activity- and nutrition-related health tips posted to the group's Facebook page.</description>
    <arm_group_label>Facebook Only Group (FG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  18-29 years old&#xD;
&#xD;
          -  Body mass index ≥ 18.5&#xD;
&#xD;
          -  Is currently not engaging in physical activity levels above the Physical Activity&#xD;
             Guidelines for Americans (PAGA; U.S. Department of Health and Human Services,&#xD;
             2008)-verified through a structured screening interview prior to participant&#xD;
             recruitment and randomization&#xD;
&#xD;
          -  Eats less than the recommended two serving of fruits and three serving of vegetables&#xD;
             per day (USDA, 2015)-verified through screening using a 10-item fruit and vegetable&#xD;
             food frequency questionnaire (F. Thompson et al., 2002)&#xD;
&#xD;
          -  No self-reported diagnosed physical/mental disability&#xD;
&#xD;
          -  Provides informed consent and completes the Physical Activity Readiness Questionnaire&#xD;
             (PAR-Q)&#xD;
&#xD;
          -  Willing to be randomized into an intervention or comparison group&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Self-reported diagnosed physical/mental disability&#xD;
&#xD;
          -  Contraindication to physical activity participation as determined by PAR-Q results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zan Gao, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physical Activity Epidemiology Laboratory</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>Harter S. Effectance motivation reconsidered: toward a developmental model. Human Development. 1978, 21:34-64.</citation>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03253406
org study id: STUDY00000386
nct id: NCT03253406
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot randomized trial is to determine (1) the effectiveness of the Polar
      M400, used in combination with a twice-weekly Facebook-delivered Social Cognitive
      Theory-based health intervention, in the promotion of more healthful physical activity and
      nutritious eating behaviors over 12 weeks in college students versus a comparison group; and
      (2) the validity and reliability of the Polar M400 in the assessment of free-living (i.e.,
      non-laboratory based) physical activity (in this case, steps per day and daily durations of
      moderate and vigorous physical activity) and energy expenditure.
The prevalence of overweight and obesity among individuals 20-39 years of age is 60.9%.
      Unfortunately, physical inactivity and poor dietary practices among this age cohort appear to
      be two major contributory factors for the preceding statistic. Among the youngest individuals
      within this age cohort are college students. Research suggests college students possess risk
      factors for overweight and obesity as many of these individuals are now independent and, for
      some, making physical activity- and nutrition-related decisions autonomously for the first
      time. Studies on obesity- and weight-related behaviors in this population suggest
      approximately 25% to 30% of college students are overweight or obese. Desai et al. also
      suggested rates of complete physical inactivity among college students is between 37% and
      46%. Unfortunately, dietary practices among college students are not ideal either.

      Poor nutritional behaviors also contribute to risk factors among this population. In a study
      among college freshman and sophomores, Racette, Deusinger, Strube, Highstein, and Deusinger
      found that 70% of the 764 college students assessed consumed less than the U.S. Department of
      Agriculture (USDA) recommendations of two servings of fruit and three servings of vegetables
      daily. Strikingly, approximately half of the students surveyed also reported high-fat fast or
      fried food consumption ≥ 3 times in the past week. Notably, a subsample of these students was
      assessed again a year later with 70% of these students gaining, on average, four kilograms.
      Indeed, other studies have demonstrated the impact poor dietary practices (e.g., consumption
      of "junk foods", sugar-sweetened beverages, or fast foods high in fat and low in nutrient
      density) and obesogenic environments (e.g., continuously eating at buffet-style student
      dining halls) can have on weight gain from freshman year of college onward. As such, not only
      is it clear that theoretically-backed physical activity interventions are needed among
      college students, there is also a distinct need to include a dietary component within these
      interventions. Technology integration within these physical activity and nutritional
      interventions among college students might present a viable approach.

      While few empirical data is available regarding health wearable use among young adults, it is
      likely that this technology-savvy age cohort represents a large proportion of the one in six
      consumers currently owning a health wearable. Further, with the number of health wearables
      sold in 2018 projected to be 110 million, it is likely that this age cohort will contribute
      substantially to this figure. Moreover, research indicates the popularity of social media
      among young adults. Indeed, among individuals 18-29 years of age, approximately 90% use at
      least one social media site. Currently, Facebook represents the most widely used social media
      site with 1.71 billion active users and individuals 18 to 34 years of age representing the
      majority of Facebook users.

      Therefore, the combined use of health wearable technology, these devices' associated
      smartphone applications, and a theoretically-driven health intervention delivered via social
      media, may prove appealing and effective as a health promotion strategy among college
      students. Specifically, use of the Polar M400 may increase college students' ability to
      self-regulate physical activity behaviors as self-regulation is posited as an important
      factor in promoting behavior change. Further, the Polar M400's associated smartphone
      application-based and Internet-based portal allows individuals to not only track physical
      activity-related metrics, but view predicted energy expenditure as well, which may allow
      individuals to self-regulate food intake in relation to daily energy expenditure. In
      combination with the Polar M400's capabilities, a twice-weekly Facebook-delivered Social
      Cognitive Theory-based health intervention may be able to increase college students'
      self-efficacy, outcome expectancy, enjoyment, and social support while decreasing barriers
      for participation in greater physical activity and nutritious eating behaviors. Relatedly, it
      is vital to also examine the preceding intervention's ability to promote changes in college
      students' intrinsic motivation for these health behaviors-an investigation which can be
      completed via application of the Self-Determination Theory.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A two-arm randomized pilot trial design will be used, with one Experimental Group and one Comparison Group. A random numbers table will be used to randomize participants with a 1:1 allocation ratio.
primary purpose: Prevention
masking: Single (Participant)
masking description: Every attempt will be made to ensure participants do not know the group with which they have been randomized, accomplished by advertising to potential college student participants that two novel, technology-based interventions will be employed in the study, with no more detail provided. After screening and randomization, participants will be informed of study intervention procedures in an identical manner regardless of group allocation via the use of a study script repeated to each participant by the study's primary investigator. The only difference between the scripts will be a discussion with experimental group participants regarding how to use the Polar M400 smartwatch during the study intervention period. Importantly, college students will be brought into the Lab for screening and baseline testing on an individual basis ensuring the individuals from different groups have no idea of the differing intervention procedures utilized between the experimental and comparison groups.
measure: Physical Activity
time frame: "Change in Physical Activity from Baseline to 6 Weeks" and "Change in Physical Activity from Baseline to 12 Weeks"
description: Will be assessed via Actigraph Link accelerometers with daily moderate-to-vigorous physical activity, light physical activity, sedentary behavior, steps per day, and energy expenditure the outcomes of interest. The Actigraph accelerometer has been validated among adults (Kaminsky & Ozemek, 2012). Participants will wear the accelerometer for seven days (ensuring the collection of physical activity data on at least two weekdays and one weekend day) as suggested for field-based accelerometer research (Trost, McIver, & Pate, 2005), with the accelerometer appended to the same wrist as the Polar M400. Accelerometry measurements will take place at baseline, six weeks, and 12 weeks to examine changes over time in the aforementioned outcomes.
measure: Cardiovascular Fitness
time frame: "Change in Cardiovascular Fitness from Baseline to 12 Weeks"
description: Evaluated with YMCA 3-minute step test (Golding, Meyers, & Sinning, 1998). Participants will step up and down for three minutes on a 12-inch riser to a metronome beep set at 96 beats per minute (each beep corresponding to one movement of the leg, with 4 beeps representing one "up-down" cycle). Participants' heart rate will be assessed immediately for one minute following the conclusion of the test by the researcher via palpation of the carotid/radial artery. The step test will be performed at baseline and 12 weeks to assess changes in cardiovascular fitness over time.
measure: Body Composition
time frame: "Change in Body Composition from Baseline to 12 Weeks"
description: Determined via bioelectrical impedance performed with the Tanita BC-558 IRONMAN® Segmental Body Composition Monitor (Tanita, Tokyo, Japan). Bioelectrical impedance sends a small electrical pulsatile wave through the body. Muscle is more conducive to electrical current transmission due to its higher water content versus fat meaning individuals with higher lean mass (i.e., lower body fat mass) will not impede the current to the degree of individuals with higher fat mass and therefore register lower body fat percentage values. Bioelectrical impedance has proven a valid measure of body composition in young adults enrolling in the military (Aandstad, Holtberget, Hageberg, Holme, & Anderssen, 2014). Notably, to decrease variability in these body composition measurements, individuals will be asked to come in for testing at approximately the same time of day and having eaten/drank similar foods/beverages the night before as they did prior to previous session(s).
measure: Body Weight
time frame: "Change in Weight from Baseline to 12 Weeks"
description: Body Weight will be assessed using a calibrated weight scale: the Tanita BC-558 IRONMAN® Segmental Body Composition Monitor (Tanita, Tokyo, Japan).
measure: Self-Efficacy
time frame: "Change in Self-Efficacy from Baseline to 12 Weeks"
description: Self-efficacy will be measured by a nine-question measure developed by Rodgers, Wilson, Hall, Fraser, and Murray (2008) wherein participants will rate how confident they feel in certain exercise situations (e.g., …"exercise when you feel discomfort" or "…exercise when you lack energy") on a percentage scale (0%: not confident at all to 100%: extremely confident in 10% increments).
measure: Social Support
time frame: "Change in Social Support from Baseline to 12 Weeks"
description: Social support will be assessed using a five-question measure adapted from the Patient-Centered Assessment and Counseling for Exercise questionnaire, with participants rating on a five-point Likert-type scale (1: almost never to 5: almost always) how often significant others support/encourage them to be physically activity (Carlson et al., 2012).
measure: Enjoyment
time frame: "Change in Enjoyment from Baseline to 12 Weeks"
description: A 5-question measure developed by Harter et al. (1978) quantified PA enjoyment as college students noted agreement with statements such as "Engaging in physical activity is the thing I like to do best" on a 5-point Likert-type scale (1: strongly disagree to 5: strongly agree).
measure: Barriers
time frame: "Change in Barriers from Baseline to 12 Weeks"
description: A 14-question measure will evaluate participants' physical activity barriers, with participants asked to rate agreement between hypothetical barriers and their own barriers on a four-point Likert-type scale (1: strongly disagree to 4: strongly agree) (Sechrist, Walker, & Pender, 1987).
measure: Outcome Expectancy
time frame: "Change in Outcome Expectancy from Baseline to 12 Weeks"
description: Outcome expectancy will be assessed with a nine-question measure developed by Trost et al. (1997) using a five-point Likert-type scale (1: strongly disagree to 5: strongly agree) to evaluate participants' agreement with responses originating from the stem "If I was to exercise on most days it would…". Sample responses are "give me more energy" and "help to control my weight".
measure: Intrinsic Motivation
time frame: "Change in Intrinsic Motivation from Baseline to 12 Weeks"
description: Will be evaluated using the interest/enjoyment subscale of the Intrinsic Motivation Inventory (McAuley, Duncan, & Tammen, 1987). This seven-question subscale requires participants to determent how true certain statements such as "I enjoyed this activity very much" and "I would describe this activity as interesting" are to them on a seven-point Likert-type scale (1: not at all true to 7: very true). The Intrinsic Motivation Inventory has demonstrated good validity in the assessment of intrinsic motivation during exercise (Deci, Eghrari, Patrick, & Leone, 1994).
measure: Nutritious Eating Behaviors
time frame: "Change in Nutritious Eating Behaviors from Baseline to 12 Weeks"
description: To assess participant eating behaviors, the National Cancer Institute's Automated Self-Administered (ASA) 24-hour Dietary Recall will be used requiring participants to recall all foods consumed within the past 24 hours. The ASA 24-hour Dietary Recall has been validated in previous research (Kipnis et al., 2003; Moshfegh et al., 2008). Participants will receive unique login information allowing them to access and complete the recall after which the researcher will be able to download and analyze the results. The ASA 24-hour Dietary recall will be administered three times on random dates during the seven days following baseline and post-intervention testing at 12 weeks, with participants notified during these testing sessions that they will be asked to complete this questionnaire. Concentration will be placed on examining changes in participants' fruit and vegetable consumption in addition to the participants' intake of fast food and sugar-sweetened beverages.
measure: Facebook-Delivered Health Intervention Adherence
time frame: "Assessed Weekly throughout 12-Week Intervention Period"
description: Regardless of group allocation, adherence to the social media-delivered health intervention previously outlined will be tracked. Briefly, the researcher will determine whether the participants have checked the Facebook health tips twice weekly in two manners following the alert each participant will receive when a new post goes live on each groups' Facebook page. First, Facebook now has a "Seen By" function that automatically indicates and lists everyone who has interacted with a new posting within a private Facebook group. Second, the researcher will also ask participants to "Like" each of the postings they read. In this way, the researcher will keep a running tally of whether each participant checked the posting by reviewing the "Seen By" function and whether the individual "Liked" the posting. Only individuals listed both within the "Seen By" function and as having "Liked" the posting will be counted as having seen the health tips.
arm group label: Polar M400 + Facebook Group (PM400+FG)
arm group type: Experimental
description: Will be provided a Polar M400 to track physical activity and energy expenditure while also being included in a Facebook group wherein Social Cognitive Theory-based physical activity and nutritious eating tips will be provided twice weekly for 12 weeks.
arm group label: Facebook Only Group (FG)
arm group type: Active Comparator
description: Included exclusively in a separate, but content-identical, Facebook group for 12 weeks.
intervention type: Behavioral
intervention name: Polar M400 + Facebook Group (PM400+FG)
description: Throughout the intervention period experimental group participants will be asked to read and try to implement the twice-weekly physical activity- and nutrition-related health tips posted to the group's Facebook page. Additionally, experimental group participants will be asked to track all physical activity with the Polar M400 smartwatch and use this information to set physical activity-related goals conducive to improved health.
arm group label: Polar M400 + Facebook Group (PM400+FG)
intervention type: Behavioral
intervention name: Facebook Only Group (FG)
description: Throughout the intervention period comparison group participants will be asked to read and try to implement the twice-weekly physical activity- and nutrition-related health tips posted to the group's Facebook page.
arm group label: Facebook Only Group (FG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zan Gao, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
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responsible party type: Sponsor
sharing ipd: Undecided