<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/NCT04412954</url>
  </required_header>
  <id_info>
    <org_study_id>2019B0560</org_study_id>
    <nct_id>NCT04412954</nct_id>
  </id_info>
  <brief_title>Improving Cardiovascular Risk Factors in Black Young Adults</brief_title>
  <official_title>Improving Cardiovascular Risk Factors in Black Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State 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>
      The objectives of the study are to conduct a randomized controlled trial to test the efficacy&#xD;
      of the Smartphone intervention on % weight loss and maintaining % weight loss at 6 and 12&#xD;
      months in a sample (N=256) of Black community college students who are overweight or obese,&#xD;
      ages 18-25 years. Investigators will also examine mediating variables of the intervention on&#xD;
      weight at 6 and 12 months, including adherence to self-monitoring, discrimination, and&#xD;
      dietary and physical activity self-efficacy. In addition, investigators will explore&#xD;
      potential moderators of weight loss at 6 months and 12 months, including depressive symptoms,&#xD;
      ideal body image, and motivation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 256 students, ages 18-25, who meet the inclusion and exclusion criteria will be&#xD;
      recruited from Columbus State Community College (CSCC). A sample size of 256 subjects (n=128&#xD;
      per each trial arm) will have sufficient power (&gt;80%) to detect an average between-group&#xD;
      difference with a moderate effect size of 0.4. The mixed effect modeling for repeated outcome&#xD;
      measures at 6 and 12 months was used for the power calculation using two-sided significance&#xD;
      level of 0.05 assuming 1) first-order autoregressive covariance structure, 2) the&#xD;
      within-structure correlation of 0.8, and 3) 20% attrition rate at 12-month follow-up. The&#xD;
      effect size of 0.4 was reasonably assumed based on data from published trials on weight-loss&#xD;
      interventions (an effect size of 0.8 using 8-week social media, 0.3 using 12-week Smartphone&#xD;
      intervention, and 0.6 using 4-month text messaging). Investigators will conduct stratified&#xD;
      recruitment by gender (female vs. male) and ethnicity (Non-Hispanic Black vs. Hispanic Black)&#xD;
      to achieve a study sample with 80% Non-Hispanic Black and 20% Hispanic and 50% male in each&#xD;
      ethnic group. The recruitment and randomization will be equally distributed with&#xD;
      approximately 10 subjects per month, which is a feasible enrollment target considering the&#xD;
      pool of eligible participants and our previous recruitment success.&#xD;
&#xD;
      Prospective participants who contact through telephone or email will undergo a preliminary&#xD;
      screening via telephone and receive an explanation of the study. Included in this screening&#xD;
      are four questions from the Eating Attitude Test-26 (EAT-26), which will be asked to&#xD;
      determine symptoms of disordered eating in the past 6 months. Those who seem to meet&#xD;
      eligibility criteria and are interested in participating will be scheduled for an in person&#xD;
      visit for the informed consent and screening process.&#xD;
&#xD;
      Following the informed consent process and baseline visit questionnaires, participants will&#xD;
      be randomly assigned to intervention or the attention-control group. Investigators will use&#xD;
      stratified randomization by sex (female vs. male) and ethnicity (Non-Hispanic Black vs.&#xD;
      Hispanic Black). For each gender strata, randomization will occur in permuted blocks of&#xD;
      varying block sizes. Subjects in each block will be randomly assigned to intervention arm or&#xD;
      attention-control arm with an allocation ratio of 1:1. The advantage of permuted block&#xD;
      randomization is that it will ensure balance in the number of subjects in the two trial arms&#xD;
      during the entire study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 5, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Physical Activity-Active Minutes/Day</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average active minutes per day will be used as measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Physical Activity-Steps/Day</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average steps taken per day will be used as measurement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food Frequency Questionnaire (FFQ) measuring change in eating habits</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>The full-length block FFQ will be used to assess diet for 7 days at each period of data collection. This is not a scale, this is a measure of foods consumed over a period of 7 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healthy Eating Index (HEI) measuring change in healthy eating score</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>A healthy eating index score will be calculated at each time period from the FFQ. The scale ranges from 0-100 with 100 being the best possible score indicating healthy diet aligning with key dietary recommendations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Participants who are Adherent to Self-Monitoring</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Intervention condition only. Adherence will be defined as those participants who enter at least 50% of their caloric goal on at least 80% of days (or 24 days per months).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dietary Self-Efficacy Scale (Diet-SE)</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>14 questions that examine the participant's belief in their ability to cut down on high caloric foods. Scale ranges from 0-4 with 0 being &quot;not at all confident&quot; and 4 bring &quot;very confident&quot; Higher overall score indicates higher levels of self confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Efficacy for Exercise Scale</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>9 questions that examine the participant's belief in their ability to complete physical activity in given circumstances. Scale ranges from 0-10 with 0 being not at all confident and 10 being the most confident. Overall scores range from 0-90 with 90 indicating high confidence levels for exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiences of Discrimination Scale (EoD)</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Examines perceived experiences of discrimination in given circumstances, such as work, public settings, banks, schools, medical care. 17 questions total. Scale ranges from never to four or more times. Four or more times being selected indicates higher levels of discrimination experiences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ) for Adults, PHQ-9</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Measures depressive symptoms using the patient health questionnaire for adults. Questions are scored from 0-3, with lower scores indicating no/lower depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ideal body image</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Measures patient perception of their current body image and their ideal body. image using a graphic scale ranging from 0-9, with 9 indicating higher levels of overweight/obesity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>30 questions to measure motivation to lose weight by examining three types of motivation. Scale ranges from 0-7 with 0 being &quot;not at all&quot; and 7 being &quot;very true&quot;. A higher score indicates higher levels of motivation for diet and exercise habits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>16 questions to measure perceived levels of emotional support. Scale ranges from 1-5 with 1 being &quot;never&quot; and 5 being &quot;always. A higher level score indicates higher level of emotional support.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">256</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health coach with Smartphone application for diet and physical activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention, using a Smartphone application for sleep monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smartphone + Text Messaging with Health Coach</intervention_name>
    <description>The program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion&#xD;
&#xD;
          -  age 17-25 years&#xD;
&#xD;
          -  Current CSCC student&#xD;
&#xD;
          -  Identify as Black&#xD;
&#xD;
          -  BMI ≥ 25&#xD;
&#xD;
          -  Speaks and reads English&#xD;
&#xD;
          -  Interested in losing weight through diet and physical activity changes&#xD;
&#xD;
          -  Owns a smartphone or iPhone Operating System (iOS) or Android compatible device&#xD;
&#xD;
          -  Ability to return for 12-month visit&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  currently pregnant or planning to become pregnant in next 12 months&#xD;
&#xD;
          -  Currently participating in another structured weight loss program or taking weight&#xD;
             loss medications or medication known to increase weight&#xD;
&#xD;
          -  Lost 10% or more of body weight in past 6 months&#xD;
&#xD;
          -  Screens positive for disordered eating symptoms&#xD;
&#xD;
          -  diagnosed with type I diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Janna D Stephens, PhD</last_name>
    <phone>5135826648</phone>
    <email>stephens.653@osu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sandra Solove, MA</last_name>
    <phone>614-247-8366</phone>
    <email>solove.3@osu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janna Stephans, PhD</last_name>
      <phone>614-292-4977</phone>
      <email>Stephens.653@osu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>September 19, 2022</last_update_submitted>
  <last_update_submitted_qc>September 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Janna Stephens</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>minority</keyword>
  <keyword>College Student</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Health Coach</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT04412954
org study id: 2019B0560
nct id: NCT04412954
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objectives of the study are to conduct a randomized controlled trial to test the efficacy
      of the Smartphone intervention on % weight loss and maintaining % weight loss at 6 and 12
      months in a sample (N=256) of Black community college students who are overweight or obese,
      ages 18-25 years. Investigators will also examine mediating variables of the intervention on
      weight at 6 and 12 months, including adherence to self-monitoring, discrimination, and
      dietary and physical activity self-efficacy. In addition, investigators will explore
      potential moderators of weight loss at 6 months and 12 months, including depressive symptoms,
      ideal body image, and motivation.
A total of 256 students, ages 18-25, who meet the inclusion and exclusion criteria will be
      recruited from Columbus State Community College (CSCC). A sample size of 256 subjects (n=128
      per each trial arm) will have sufficient power (>80%) to detect an average between-group
      difference with a moderate effect size of 0.4. The mixed effect modeling for repeated outcome
      measures at 6 and 12 months was used for the power calculation using two-sided significance
      level of 0.05 assuming 1) first-order autoregressive covariance structure, 2) the
      within-structure correlation of 0.8, and 3) 20% attrition rate at 12-month follow-up. The
      effect size of 0.4 was reasonably assumed based on data from published trials on weight-loss
      interventions (an effect size of 0.8 using 8-week social media, 0.3 using 12-week Smartphone
      intervention, and 0.6 using 4-month text messaging). Investigators will conduct stratified
      recruitment by gender (female vs. male) and ethnicity (Non-Hispanic Black vs. Hispanic Black)
      to achieve a study sample with 80% Non-Hispanic Black and 20% Hispanic and 50% male in each
      ethnic group. The recruitment and randomization will be equally distributed with
      approximately 10 subjects per month, which is a feasible enrollment target considering the
      pool of eligible participants and our previous recruitment success.

      Prospective participants who contact through telephone or email will undergo a preliminary
      screening via telephone and receive an explanation of the study. Included in this screening
      are four questions from the Eating Attitude Test-26 (EAT-26), which will be asked to
      determine symptoms of disordered eating in the past 6 months. Those who seem to meet
      eligibility criteria and are interested in participating will be scheduled for an in person
      visit for the informed consent and screening process.

      Following the informed consent process and baseline visit questionnaires, participants will
      be randomly assigned to intervention or the attention-control group. Investigators will use
      stratified randomization by sex (female vs. male) and ethnicity (Non-Hispanic Black vs.
      Hispanic Black). For each gender strata, randomization will occur in permuted blocks of
      varying block sizes. Subjects in each block will be randomly assigned to intervention arm or
      attention-control arm with an allocation ratio of 1:1. The advantage of permuted block
      randomization is that it will ensure balance in the number of subjects in the two trial arms
      during the entire study period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Body Weight
time frame: Baseline to 12 months
description: Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS)
measure: Change in Physical Activity-Active Minutes/Day
time frame: Baseline to 12 months
description: Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average active minutes per day will be used as measurement
measure: Change in Physical Activity-Steps/Day
time frame: Baseline to 12 months
description: Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average steps taken per day will be used as measurement.
measure: Food Frequency Questionnaire (FFQ) measuring change in eating habits
time frame: Baseline to 12 months
description: The full-length block FFQ will be used to assess diet for 7 days at each period of data collection. This is not a scale, this is a measure of foods consumed over a period of 7 days.
measure: Healthy Eating Index (HEI) measuring change in healthy eating score
time frame: Baseline to 12 months
description: A healthy eating index score will be calculated at each time period from the FFQ. The scale ranges from 0-100 with 100 being the best possible score indicating healthy diet aligning with key dietary recommendations.
measure: Rate of Participants who are Adherent to Self-Monitoring
time frame: Baseline to 12 months
description: Intervention condition only. Adherence will be defined as those participants who enter at least 50% of their caloric goal on at least 80% of days (or 24 days per months).
measure: Change in Dietary Self-Efficacy Scale (Diet-SE)
time frame: Baseline to 12 months
description: 14 questions that examine the participant's belief in their ability to cut down on high caloric foods. Scale ranges from 0-4 with 0 being "not at all confident" and 4 bring "very confident" Higher overall score indicates higher levels of self confidence.
measure: Change in Self-Efficacy for Exercise Scale
time frame: Baseline to 12 months
description: 9 questions that examine the participant's belief in their ability to complete physical activity in given circumstances. Scale ranges from 0-10 with 0 being not at all confident and 10 being the most confident. Overall scores range from 0-90 with 90 indicating high confidence levels for exercise.
measure: Experiences of Discrimination Scale (EoD)
time frame: Baseline to 12 months
description: Examines perceived experiences of discrimination in given circumstances, such as work, public settings, banks, schools, medical care. 17 questions total. Scale ranges from never to four or more times. Four or more times being selected indicates higher levels of discrimination experiences.
measure: Patient Health Questionnaire (PHQ) for Adults, PHQ-9
time frame: Baseline to 12 months
description: Measures depressive symptoms using the patient health questionnaire for adults. Questions are scored from 0-3, with lower scores indicating no/lower depressive symptoms.
measure: Ideal body image
time frame: Baseline to 12 months
description: Measures patient perception of their current body image and their ideal body. image using a graphic scale ranging from 0-9, with 9 indicating higher levels of overweight/obesity.
measure: Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise
time frame: Baseline to 12 months
description: 30 questions to measure motivation to lose weight by examining three types of motivation. Scale ranges from 0-7 with 0 being "not at all" and 7 being "very true". A higher score indicates higher levels of motivation for diet and exercise habits
measure: NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support
time frame: Baseline to 12 months
description: 16 questions to measure perceived levels of emotional support. Scale ranges from 1-5 with 1 being "never" and 5 being "always. A higher level score indicates higher level of emotional support.
arm group label: Intervention
arm group type: Experimental
description: Health coach with Smartphone application for diet and physical activity
arm group label: Control
arm group type: No Intervention
description: No intervention, using a Smartphone application for sleep monitoring
intervention type: Behavioral
intervention name: Smartphone + Text Messaging with Health Coach
description: The program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit.
arm group label: Intervention
criteria: 
gender: All
minimum age: 17 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janna D Stephens, PhD
phone: 5135826648
email: stephens.653@osu.edu
last name: Sandra Solove, MA
phone: 614-247-8366
email: solove.3@osu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Janna Stephens
investigator title: Assistant Professor
sharing ipd: No