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/NCT05970042</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00127414</org_study_id>
      <secondary_id>5K23MD013899</secondary_id>
      <nct_id>NCT05970042</nct_id>
    </id_info>
    <brief_title>Investigating the Effects of the &quot;GameDay Ready&quot; Behavioral Weight Management Program for Black Men Living in the Rural South</brief_title>
    <official_title>Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American Men Living in the Rural South</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of South Carolina</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>
        This pilot study investigates the effects of a newly developed 12-week weight management&#xD;
        program called &quot;GameDay Ready&quot; (compared to a walking and general health education program)&#xD;
        for decreasing body weight among Black men who live in the rural South. The researchers&#xD;
        expect to see evidence of greater weight loss among participants randomized to receive the&#xD;
        &quot;GameDay Ready&quot; program.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 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>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Body weight</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Participants' body weight will be measured in pounds using a portable, professional-grade scale. Changes in body weight will be compared between the intervention and comparison programs.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Body mass index (BMI)</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Participants' body weight will be measured in pounds using a portable, professional-grade scale, and height will be measured using a portable, professional-grade stadiometer. BMI will be computed as weight (lb) / [height (in)]2 x 703. Changes in BMI will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist circumference (WC)</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Participants' WC will be measured using anthropometric measuring tape. Changes in WC will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure (BP)</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Participants' systolic and diastolic BP will be measured using an automatic blood pressure machine. Changes in BP will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Moderate-to-vigorous physical activity (MVPA)</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Average minutes of MVPA will be measured over 7 consecutive days using research-grade, wrist-worn accelerometers (ActiGraph). Changes in MVPA will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fruit and vegetable consumption</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Fruit and vegetable consumption will be measured using the National Cancer Institute's Dietary Screener Questionnaire that was used in the 2009-2010 National Health and Nutrition Examination Survey. Changes in fruit and vegetable consumption will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Added sugar consumption</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Added sugar consumption will be measured using the National Cancer Institute's Dietary Screener Questionnaire that was used in the 2009-2010 National Health and Nutrition Examination Survey. Changes in added sugar consumption will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Whole grain consumption</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Whole grain consumption will be measured using the National Cancer Institute's Dietary Screener Questionnaire that was used in the 2009-2010 National Health and Nutrition Examination Survey. Changes in whole grain consumption will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social support for exercise and diet</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Social support for exercise and diet will be measured using validated scales developed by Sallis et al. Changes in social support for exercise and diet will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived environmental support for physical activity</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Perceived environmental support for physical activity will be measured using the 33-item Rural Active Living Perceived Environmental Support Scale. Changes in perceived environmental support for physical activity will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motivation for weight loss</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Motivation for weight loss will be measured using an 8-item Weight Control Motivation Scale. Changes in motivation for weight loss will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motivation for healthy eating</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Motivation for healthy eating will be measured using a 15-item scale of the Treatment Self-Regulation Questionnaire. Changes in motivation for healthy eating will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motivation for physical activity</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Motivation for physical activity will be measured using the 24-item Motivation for Exercise Scale. Changes in motivation for physical activity will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exercise self-efficacy</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Exercise self-efficacy will be measured using a 16-item Self-Efficacy for Exercise Scale. Changes in exercise self-efficacy will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relatedness to others in physical activity</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Relatedness to others in physical activity will be measured using a 6-item scale developed by Wilson &amp; Bengoechea. Changes in relatedness to others in physical activity will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived stress</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Perceived stress will be measured using the 10-item Perceived Stress Scale. Changes in perceived stress will be compared between the intervention and comparison programs.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Neighborhood surroundings</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Neighborhood surroundings will be measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Neighborhood safety</measure>
      <time_frame>Baseline, post-intervention (12 weeks), and 3 months post-intervention</time_frame>
      <description>Neighborhood safety will be measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>GameDay Ready Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>GameDay Ready is a 12-week, group-based behavioral weight management program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Walking and General Health Education Program</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>GameDay Ready</intervention_name>
      <description>GameDay Ready is a 12-week, group-based behavioral weight management program in which participants will meet in-person once per week at a publicly accessible walking track. The GameDay Ready program promotes increasing physical activity, reducing sedentary time, and improving dietary habits through education, behavioral self-monitoring, and goal setting. Each 60-minute intervention session includes a brief educational component followed by a group discussion of weekly progress. Following a short warmup walk, participants engage in group-based competitive physical activities and then a short cooldown walk. Participants then set individual and group-based goals for the upcoming week and discuss strategies for overcoming barriers to achieving goals. The program is sensitive to intersectional influences of gender, race, and rurality on health; and strategies to enhance motivation are threaded throughout the program.</description>
      <arm_group_label>GameDay Ready Program</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Walking and General Health Education</intervention_name>
      <description>Participants receiving the comparison program will complete a 12-week walking and general health education program. Group sessions meet once per week at a publicly accessible walking track, and each 60-minute session consists of a brief educational component on a health topic followed by walking and socializing during the remainder of the session.</description>
      <arm_group_label>Walking and General Health Education Program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Self-identified African American or Black American male&#xD;
  &#xD;
            -  25-65 years of age&#xD;
  &#xD;
            -  BMI 27kg/m2 to ≤50kg/m2 (those with a BMI &gt;45 will need documented approval by a&#xD;
               healthcare provider to participate in the study)&#xD;
  &#xD;
            -  Live in a rural area of South Carolina and have lived in a rural area for at least 1&#xD;
               year&#xD;
  &#xD;
            -  Able to speak and understand English&#xD;
  &#xD;
            -  Willing to be randomized to the intervention or comparison program&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Positive response to any question on the Physical Activity Readiness Questionnaire&#xD;
               (PAR-Q) (Participant may be included if approval is provided and documented by a&#xD;
               healthcare provider)&#xD;
  &#xD;
            -  Currently participating in another weight loss trial or program or have participated&#xD;
               in a trial or program within 6 months prior to starting the intervention&#xD;
  &#xD;
            -  Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood&#xD;
               pressure ≥100 mm Hg), diabetes, or asthma (Participant may be included if approval is&#xD;
               provided and documented by a healthcare provider)&#xD;
  &#xD;
            -  Pulmonary disease requiring supplemental oxygen or daily use of short-acting&#xD;
               bronchodilators&#xD;
  &#xD;
            -  Any musculoskeletal condition that would preclude meeting recommended levels of&#xD;
               moderate-to- vigorous physical activity&#xD;
  &#xD;
            -  Within 30 days prior to participating in the study, have taken prescription or&#xD;
               nonprescription medications, herbals, or supplements for weight loss&#xD;
  &#xD;
            -  On special diet for a serious health condition (does not include general dietary&#xD;
               advice from a healthcare provider for common risk factors such as hypertension,&#xD;
               diabetes, or hyperlipidemia).&#xD;
  &#xD;
            -  Major surgery in the past 6 months&#xD;
  &#xD;
            -  Have undergone weight loss surgery or considering weight loss surgery within the next&#xD;
               6 months&#xD;
  &#xD;
            -  Have been treated for cancer in the past 12 months (other than non-melanoma skin&#xD;
               cancer)&#xD;
  &#xD;
            -  Weight loss ≥5% during the past 6 months&#xD;
  &#xD;
            -  Plans to move to another county in the next 6 months&#xD;
  &#xD;
            -  Any other perceived physical or mental health-related condition that would preclude&#xD;
               participating in a behavioral program designed to promote weight loss&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Demetrius A Abshire, PhD</last_name>
      <phone>803-576-6262</phone>
      <email>abshired@mailbox.sc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of South Carolina</name>
        <address>
          <city>Columbia</city>
          <state>South Carolina</state>
          <zip>29208</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Demetrius A Abshire, PhD</last_name>
        <phone>803-576-6262</phone>
        <email>abshired@mailbox.sc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of South Carolina</investigator_affiliation>
      <investigator_full_name>Demetrius Abshire</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data can be shared upon reasonable request.</ipd_description>
    </patient_data>
    <!-- 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/NCT05970042
  org study id: Pro00127414
  secondary id: 5K23MD013899
  nct id: NCT05970042
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This pilot study investigates the effects of a newly developed 12-week weight management
        program called "GameDay Ready" (compared to a walking and general health education program)
        for decreasing body weight among Black men who live in the rural South. The researchers
        expect to see evidence of greater weight loss among participants randomized to receive the
        "GameDay Ready" program.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Body weight
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Participants' body weight will be measured in pounds using a portable, professional-grade scale. Changes in body weight will be compared between the intervention and comparison programs.
  measure: Body mass index (BMI)
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Participants' body weight will be measured in pounds using a portable, professional-grade scale, and height will be measured using a portable, professional-grade stadiometer. BMI will be computed as weight (lb) / [height (in)]2 x 703. Changes in BMI will be compared between the intervention and comparison programs.
  measure: Waist circumference (WC)
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Participants' WC will be measured using anthropometric measuring tape. Changes in WC will be compared between the intervention and comparison programs.
  measure: Blood pressure (BP)
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Participants' systolic and diastolic BP will be measured using an automatic blood pressure machine. Changes in BP will be compared between the intervention and comparison programs.
  measure: Moderate-to-vigorous physical activity (MVPA)
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Average minutes of MVPA will be measured over 7 consecutive days using research-grade, wrist-worn accelerometers (ActiGraph). Changes in MVPA will be compared between the intervention and comparison programs.
  measure: Fruit and vegetable consumption
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Fruit and vegetable consumption will be measured using the National Cancer Institute's Dietary Screener Questionnaire that was used in the 2009-2010 National Health and Nutrition Examination Survey. Changes in fruit and vegetable consumption will be compared between the intervention and comparison programs.
  measure: Added sugar consumption
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Added sugar consumption will be measured using the National Cancer Institute's Dietary Screener Questionnaire that was used in the 2009-2010 National Health and Nutrition Examination Survey. Changes in added sugar consumption will be compared between the intervention and comparison programs.
  measure: Whole grain consumption
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Whole grain consumption will be measured using the National Cancer Institute's Dietary Screener Questionnaire that was used in the 2009-2010 National Health and Nutrition Examination Survey. Changes in whole grain consumption will be compared between the intervention and comparison programs.
  measure: Social support for exercise and diet
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Social support for exercise and diet will be measured using validated scales developed by Sallis et al. Changes in social support for exercise and diet will be compared between the intervention and comparison programs.
  measure: Perceived environmental support for physical activity
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Perceived environmental support for physical activity will be measured using the 33-item Rural Active Living Perceived Environmental Support Scale. Changes in perceived environmental support for physical activity will be compared between the intervention and comparison programs.
  measure: Motivation for weight loss
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Motivation for weight loss will be measured using an 8-item Weight Control Motivation Scale. Changes in motivation for weight loss will be compared between the intervention and comparison programs.
  measure: Motivation for healthy eating
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Motivation for healthy eating will be measured using a 15-item scale of the Treatment Self-Regulation Questionnaire. Changes in motivation for healthy eating will be compared between the intervention and comparison programs.
  measure: Motivation for physical activity
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Motivation for physical activity will be measured using the 24-item Motivation for Exercise Scale. Changes in motivation for physical activity will be compared between the intervention and comparison programs.
  measure: Exercise self-efficacy
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Exercise self-efficacy will be measured using a 16-item Self-Efficacy for Exercise Scale. Changes in exercise self-efficacy will be compared between the intervention and comparison programs.
  measure: Relatedness to others in physical activity
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Relatedness to others in physical activity will be measured using a 6-item scale developed by Wilson & Bengoechea. Changes in relatedness to others in physical activity will be compared between the intervention and comparison programs.
  measure: Perceived stress
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Perceived stress will be measured using the 10-item Perceived Stress Scale. Changes in perceived stress will be compared between the intervention and comparison programs.
  measure: Neighborhood surroundings
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Neighborhood surroundings will be measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale.
  measure: Neighborhood safety
  time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
  description: Neighborhood safety will be measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale.
  arm group label: GameDay Ready Program
  arm group type: Experimental
  description: GameDay Ready is a 12-week, group-based behavioral weight management program.
  arm group label: Walking and General Health Education Program
  arm group type: Active Comparator
  description: The walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men.
  intervention type: Behavioral
  intervention name: GameDay Ready
  description: GameDay Ready is a 12-week, group-based behavioral weight management program in which participants will meet in-person once per week at a publicly accessible walking track. The GameDay Ready program promotes increasing physical activity, reducing sedentary time, and improving dietary habits through education, behavioral self-monitoring, and goal setting. Each 60-minute intervention session includes a brief educational component followed by a group discussion of weekly progress. Following a short warmup walk, participants engage in group-based competitive physical activities and then a short cooldown walk. Participants then set individual and group-based goals for the upcoming week and discuss strategies for overcoming barriers to achieving goals. The program is sensitive to intersectional influences of gender, race, and rurality on health; and strategies to enhance motivation are threaded throughout the program.
  arm group label: GameDay Ready Program
  intervention type: Behavioral
  intervention name: Walking and General Health Education
  description: Participants receiving the comparison program will complete a 12-week walking and general health education program. Group sessions meet once per week at a publicly accessible walking track, and each 60-minute session consists of a brief educational component on a health topic followed by walking and socializing during the remainder of the session.
  arm group label: Walking and General Health Education Program
  criteria: 
  gender: Male
  minimum age: 25 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Demetrius A Abshire, PhD
  phone: 803-576-6262
  email: abshired@mailbox.sc.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of South Carolina
  investigator full name: Demetrius Abshire
  investigator title: Assistant Professor
  sharing ipd: Yes
  ipd description: Data can be shared upon reasonable request.