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/NCT05981508</url>
    </required_header>
    <id_info>
      <org_study_id>23-1598</org_study_id>
      <secondary_id>U24DK132715</secondary_id>
      <nct_id>NCT05981508</nct_id>
    </id_info>
    <brief_title>Online Family Dyadic Skills Training for Black Adults in Behavioral Weight Loss Program</brief_title>
    <acronym>TEAM+</acronym>
    <official_title>Feasibility of Conducting an Online Family Dyadic/Couple Skills Training for Black Adults Enrolled in a Behavioral Weight Loss Intervention - Together, Eating and Activity, Matter+ (TEAM+)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Splendor-NC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of North Carolina, Chapel Hill</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 purpose of this research study is to test the feasibility and acceptability of an&#xD;
        interactive counselor -led online family skills training as part of a behavioral weight loss&#xD;
        program for Black Adults.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nearly half (49.9%) of Black adults in the United States live with obesity. Black adults are&#xD;
        underrepresented in standard behavioral weight loss (BWL) interventions and experience&#xD;
        sub-optimal weight loss outcomes when included in such programs. Cultural adaptations to BWL&#xD;
        interventions that recognize the family behavioral context and address the cultural value of&#xD;
        family among Black populations are needed to improve weight loss outcomes. Prior research,&#xD;
        including our randomized controlled pilot, Together, Eating and Activity, Matter Plus&#xD;
        (TEAM+), have incorporated family skills training to enhance family involvement, targeting&#xD;
        cohesion and communication, in addition to core weight loss curriculum. However, family&#xD;
        inclusion in weight loss interventions can result in additional barriers to retention and&#xD;
        adherence.&#xD;
  &#xD;
        Technology has become an attractive delivery format to increase reach to at-risk populations,&#xD;
        as a well-designed online program can address issues of timely access and geographical&#xD;
        location (or distance from program sites), which are linked to low retention of Black&#xD;
        participants. However, technology uptake among Blacks populations still lags due to mistrust,&#xD;
        skepticism, concerns about confidentiality, privacy, and remote interaction with staff.&#xD;
        Increases in acceptance and utilization of telemedicine and mobile-health were reported&#xD;
        during the COVID-19 pandemic. Considering the time and location burden already associated&#xD;
        with behavioral weight loss sessions, it is important to identify strategies to increase&#xD;
        access that are both feasible and acceptable in the target population. Currently the&#xD;
        feasibility and acceptability of an online family dyadic skills training is unknown among&#xD;
        Black adults.&#xD;
  &#xD;
        TEAM+ is an in-person 3-month family enhanced BWL intervention designed for Black adults&#xD;
        consisting of a family dyadic skills training and core behavioral weight loss sessions. For&#xD;
        this proposed pilot study, 20 black adults interested in weight loss will be recruited with a&#xD;
        family member committed to attending both the skills training and core sessions. Participants&#xD;
        must 1) be ≥18 years of age, 2) self-identify as Black/African American, 3) reside in the&#xD;
        Raleigh/Durham/Chapel Hill area, and 4) have internet access. The core sessions will be&#xD;
        delivered in person. To test the feasibility and acceptability of an interactive&#xD;
        counselor-led online training, the family dyadic skills training will be delivered online&#xD;
        using a web-conferencing platform (e.g., Zoom).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Body Weight</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
      <description>Body weight (kg) expressed as a continuous variable will be collected on a digital scale.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Waist Circumference</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>Measured in a standing position, at midpoint between the lower border of the last rib and the upper border of the iliac crest on the horizontal place, using an inextensible Gulick measuring tape graduated in cm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Body Mass Index (BMI)</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>Body mass index calculated from kg/m^2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Change in Blood Pressure</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>Blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Caloric Intake</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>To assess behavioral change the Automated-Self Administered Recall System (ASA24) will be used to determine daily kcal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Physical Activity</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>The Paffenbarger Physical Activity Questionnaire (PPAQ) is an eight-item questionnaire that is scored by measuring minutes per week of Moderate to Vigorous Physical Activity (MVPA) by adding block per day and and physical activity of at least moderate level; not measured on a scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Self-Regulation of Eating Behaviors</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>The Eating Behavior Inventory (20 items) measures the adoption of eating behaviors associated with weight loss (e.g., monitoring quantity eaten, frequency of weighing, shopping from a list) to measure self-regulation behaviors. Items are rated on a 5-point frequency scale from &quot;never or hardly ever&quot; to &quot;always or almost always.&quot; Scores range from 26 to 130.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Self-Efficacy of Eating Behaviors</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>Measured by survey responses to the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF).Scale goes from 0 (not at all confident) to 10 (very confident). Higher scores mean better self efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Self-Efficacy of Physical Activity</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>The confidence subscale of the Patient-centered Assessment and Counseling for Exercise Adult Diet and Physical Activity Measure (6 items; ) measures confidence in participating in regular exercise or physical activity in different situations (e.g., &quot;How confident are you that you would participate in regular exercise or physical activity: When I am tired?&quot;). Items rated on a scale from 1 (&quot;not at all confident&quot;) to 6 (&quot;extremely confident&quot;). Higher scores show higher self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Social Support Effectiveness</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>Social Support Effectiveness Survey (25 items) measures partner social support effectiveness. The measure includes items assessing the quantity and quality (e.g., &quot;To what extent did you wish this person's advice or information had been different somehow-for instance, a different type of help, or offered in a different way or at a different time?&quot;) on a rating scale ranging from &quot;not at all&quot; to &quot;extremely&quot; for 3 types of support (e.g., emotional, informational, and instrumental). The measure also assesses negative byproducts of support provided (e.g., feelings of guilt or indebtedness) using Yes/No options. Total scores range from 0 to 80, with higher scores indicating more effective support.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Social Support for Eating</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>The Social Support and Eating Habits Survey (10 items) measures social support specific to healthy eating. Subscales assess encouragement for eating behaviors from partners (e.g., &quot;Encouraged me not to eat 'unhealthy food' when I am tempted&quot;) and discouragement for eating behaviors from partners (e.g., &quot;Brought home foods I am trying not to eat&quot;). The items are rated on a scale of &quot;none&quot; to &quot;very often.&quot; Total scores range from 5 to 50, with higher scores indicating more social support for eating behaviors.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Social Support for Exercise</measure>
      <time_frame>Baseline,12 weeks</time_frame>
      <description>The exercise participation subscale of the Social Support and Exercise Survey (10 items) measures social support specific to exercise behaviors. The subscale assesses the level of support for exercise from partners. Subscale example items include &quot;Exercised with me&quot; and &quot;Criticized or made fun of me for exercising.&quot; Total scores range from 5 to 50, with higher scores indicating more social support for exercise participation behaviors.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Family Communication</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
      <description>Family communication is assessed with the communication subscale of the McMaster Family Assessment Device (6 items). Communication is defined as the exchange of information among family members. Items focused on whether verbal messages were clear and direct for the intended recipient. Responses ranged from &quot;strongly agree&quot; to &quot;strongly disagree.&quot; Higher scores represent unhealthy communication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Family Cohesion</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
      <description>The cohesion subscale (10 items) of the Family Adaptability and Cohesion Evaluation Scale III measures the emotional bonding family members have with one another. Items like &quot;Family members ask each other for help&quot; rated on a 5-point Likert scale from &quot;almost never&quot; to &quot;almost always.&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Family Emotional Involvement</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
      <description>The family emotional involvement (7 items) of the Family Emotional Involvement and Criticism Scale rate items on a 5-point Likert scale, as above.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Family Perceived Criticism</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
      <description>The perceived criticism (7 items) subscales of the Family Emotional Involvement and Criticism Scale rate items like on a 5-point Likert scale, as above.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Family Collaborative problem solving</measure>
      <time_frame>Baseline, 12 weeks</time_frame>
      <description>The Family Problem-Solving Communication Index (10 items) was used to measure the specific communication style that families use to manage and solve problems and conflicts in various types of stressful situations. Consisting of 2 subscales, affirmatory communication and incendiary communication, the response options were &quot;false,&quot; &quot;mostly false,&quot; &quot;mostly true,&quot; and &quot;true.&quot;</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Body Weight</condition>
    <condition>Body Weight Changes</condition>
    <condition>Obesity</condition>
    <condition>Overweight and Obesity</condition>
    <condition>Overweight</condition>
    <condition>Behavior, Eating</condition>
    <condition>Physical Inactivity</condition>
    <condition>Chronic Disease</condition>
    <condition>Weight Loss</condition>
    <condition>Weight Reduction</condition>
    <arm_group>
      <arm_group_label>In-person Family Skills Training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The index partner will participate in intervention as a dyad with a family member with an in-person skills training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Online Family Skills Training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The index partner will participate in intervention as a dyad with a family member with an online skills training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Together, Eating and Activity, Matter Plus (TEAM+) Online</intervention_name>
      <description>TEAM+ is a 3-month, family enhanced behavioral weight loss (BWL) intervention designed for Black adults consisting of an online family dyadic skills training and in-person core behavioral weight loss sessions.</description>
      <arm_group_label>Online Family Skills Training</arm_group_label>
      <other_name>TEAM +</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Together, Eating and Activity, Matter Plus (TEAM+) In-Person</intervention_name>
      <description>TEAM+ is a 3-month, family enhanced behavioral weight loss (BWL) intervention designed for Black adults consisting of in-person family dyadic skills training and core behavioral weight loss sessions.</description>
      <arm_group_label>In-person Family Skills Training</arm_group_label>
      <other_name>TEAM +</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  self-identify as a Black or African American,&#xD;
  &#xD;
            -  are between 18-75 years old&#xD;
  &#xD;
            -  have a family member willing to attend study session with you&#xD;
  &#xD;
            -  have Internet access&#xD;
  &#xD;
            -  reside in the Raleigh/Durham/Chapel Hill area,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  not interested in losing weight&#xD;
  &#xD;
            -  have any conditions affecting weight&#xD;
  &#xD;
            -  currently receiving cancer treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Candice Alick, PhD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of North Carolina, Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Candice Alick, PhD, MS</last_name>
      <phone>919-966-6080</phone>
      <email>alick@email.unc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Center for Health Promotion and Disease Prevention</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27499</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Candice Alick, PhD, MS</last_name>
        <phone>919-966-6080</phone>
        <email>alick@email.unc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Overweight</mesh_term>
      <mesh_term>Body Weight</mesh_term>
      <mesh_term>Weight Loss</mesh_term>
      <mesh_term>Chronic Disease</mesh_term>
      <mesh_term>Body Weight Changes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>beginning 9 and continuing for 36 months following publication</ipd_time_frame>
      <ipd_access_criteria>Investigator has approved from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.</ipd_access_criteria>
    </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/NCT05981508
  org study id: 23-1598
  secondary id: U24DK132715
  nct id: NCT05981508
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this research study is to test the feasibility and acceptability of an
        interactive counselor -led online family skills training as part of a behavioral weight loss
        program for Black Adults.
  Nearly half (49.9%) of Black adults in the United States live with obesity. Black adults are
        underrepresented in standard behavioral weight loss (BWL) interventions and experience
        sub-optimal weight loss outcomes when included in such programs. Cultural adaptations to BWL
        interventions that recognize the family behavioral context and address the cultural value of
        family among Black populations are needed to improve weight loss outcomes. Prior research,
        including our randomized controlled pilot, Together, Eating and Activity, Matter Plus
        (TEAM+), have incorporated family skills training to enhance family involvement, targeting
        cohesion and communication, in addition to core weight loss curriculum. However, family
        inclusion in weight loss interventions can result in additional barriers to retention and
        adherence.
  
        Technology has become an attractive delivery format to increase reach to at-risk populations,
        as a well-designed online program can address issues of timely access and geographical
        location (or distance from program sites), which are linked to low retention of Black
        participants. However, technology uptake among Blacks populations still lags due to mistrust,
        skepticism, concerns about confidentiality, privacy, and remote interaction with staff.
        Increases in acceptance and utilization of telemedicine and mobile-health were reported
        during the COVID-19 pandemic. Considering the time and location burden already associated
        with behavioral weight loss sessions, it is important to identify strategies to increase
        access that are both feasible and acceptable in the target population. Currently the
        feasibility and acceptability of an online family dyadic skills training is unknown among
        Black adults.
  
        TEAM+ is an in-person 3-month family enhanced BWL intervention designed for Black adults
        consisting of a family dyadic skills training and core behavioral weight loss sessions. For
        this proposed pilot study, 20 black adults interested in weight loss will be recruited with a
        family member committed to attending both the skills training and core sessions. Participants
        must 1) be ≥18 years of age, 2) self-identify as Black/African American, 3) reside in the
        Raleigh/Durham/Chapel Hill area, and 4) have internet access. The core sessions will be
        delivered in person. To test the feasibility and acceptability of an interactive
        counselor-led online training, the family dyadic skills training will be delivered online
        using a web-conferencing platform (e.g., Zoom).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Body Weight
  time frame: Baseline, 12 weeks
  description: Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
  measure: Change in Waist Circumference
  time frame: Baseline,12 weeks
  description: Measured in a standing position, at midpoint between the lower border of the last rib and the upper border of the iliac crest on the horizontal place, using an inextensible Gulick measuring tape graduated in cm.
  measure: Change in Body Mass Index (BMI)
  time frame: Baseline,12 weeks
  description: Body mass index calculated from kg/m^2.
  measure: Mean Change in Blood Pressure
  time frame: Baseline,12 weeks
  description: Blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study.
  measure: Change in Caloric Intake
  time frame: Baseline,12 weeks
  description: To assess behavioral change the Automated-Self Administered Recall System (ASA24) will be used to determine daily kcal.
  measure: Change in Physical Activity
  time frame: Baseline,12 weeks
  description: The Paffenbarger Physical Activity Questionnaire (PPAQ) is an eight-item questionnaire that is scored by measuring minutes per week of Moderate to Vigorous Physical Activity (MVPA) by adding block per day and and physical activity of at least moderate level; not measured on a scale.
  measure: Change in Self-Regulation of Eating Behaviors
  time frame: Baseline,12 weeks
  description: The Eating Behavior Inventory (20 items) measures the adoption of eating behaviors associated with weight loss (e.g., monitoring quantity eaten, frequency of weighing, shopping from a list) to measure self-regulation behaviors. Items are rated on a 5-point frequency scale from "never or hardly ever" to "always or almost always." Scores range from 26 to 130.
  measure: Change in Self-Efficacy of Eating Behaviors
  time frame: Baseline,12 weeks
  description: Measured by survey responses to the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF).Scale goes from 0 (not at all confident) to 10 (very confident). Higher scores mean better self efficacy.
  measure: Change in Self-Efficacy of Physical Activity
  time frame: Baseline,12 weeks
  description: The confidence subscale of the Patient-centered Assessment and Counseling for Exercise Adult Diet and Physical Activity Measure (6 items; ) measures confidence in participating in regular exercise or physical activity in different situations (e.g., "How confident are you that you would participate in regular exercise or physical activity: When I am tired?"). Items rated on a scale from 1 ("not at all confident") to 6 ("extremely confident"). Higher scores show higher self-efficacy.
  measure: Change in Social Support Effectiveness
  time frame: Baseline,12 weeks
  description: Social Support Effectiveness Survey (25 items) measures partner social support effectiveness. The measure includes items assessing the quantity and quality (e.g., "To what extent did you wish this person's advice or information had been different somehow-for instance, a different type of help, or offered in a different way or at a different time?") on a rating scale ranging from "not at all" to "extremely" for 3 types of support (e.g., emotional, informational, and instrumental). The measure also assesses negative byproducts of support provided (e.g., feelings of guilt or indebtedness) using Yes/No options. Total scores range from 0 to 80, with higher scores indicating more effective support.
  measure: Change in Social Support for Eating
  time frame: Baseline,12 weeks
  description: The Social Support and Eating Habits Survey (10 items) measures social support specific to healthy eating. Subscales assess encouragement for eating behaviors from partners (e.g., "Encouraged me not to eat 'unhealthy food' when I am tempted") and discouragement for eating behaviors from partners (e.g., "Brought home foods I am trying not to eat"). The items are rated on a scale of "none" to "very often." Total scores range from 5 to 50, with higher scores indicating more social support for eating behaviors.
  measure: Change in Social Support for Exercise
  time frame: Baseline,12 weeks
  description: The exercise participation subscale of the Social Support and Exercise Survey (10 items) measures social support specific to exercise behaviors. The subscale assesses the level of support for exercise from partners. Subscale example items include "Exercised with me" and "Criticized or made fun of me for exercising." Total scores range from 5 to 50, with higher scores indicating more social support for exercise participation behaviors.
  measure: Change in Family Communication
  time frame: Baseline, 12 weeks
  description: Family communication is assessed with the communication subscale of the McMaster Family Assessment Device (6 items). Communication is defined as the exchange of information among family members. Items focused on whether verbal messages were clear and direct for the intended recipient. Responses ranged from "strongly agree" to "strongly disagree." Higher scores represent unhealthy communication.
  measure: Change in Family Cohesion
  time frame: Baseline, 12 weeks
  description: The cohesion subscale (10 items) of the Family Adaptability and Cohesion Evaluation Scale III measures the emotional bonding family members have with one another. Items like "Family members ask each other for help" rated on a 5-point Likert scale from "almost never" to "almost always."
  measure: Change in Family Emotional Involvement
  time frame: Baseline, 12 weeks
  description: The family emotional involvement (7 items) of the Family Emotional Involvement and Criticism Scale rate items on a 5-point Likert scale, as above.
  measure: Change in Family Perceived Criticism
  time frame: Baseline, 12 weeks
  description: The perceived criticism (7 items) subscales of the Family Emotional Involvement and Criticism Scale rate items like on a 5-point Likert scale, as above.
  measure: Change in Family Collaborative problem solving
  time frame: Baseline, 12 weeks
  description: The Family Problem-Solving Communication Index (10 items) was used to measure the specific communication style that families use to manage and solve problems and conflicts in various types of stressful situations. Consisting of 2 subscales, affirmatory communication and incendiary communication, the response options were "false," "mostly false," "mostly true," and "true."
  arm group label: In-person Family Skills Training
  arm group type: Active Comparator
  description: The index partner will participate in intervention as a dyad with a family member with an in-person skills training.
  arm group label: Online Family Skills Training
  arm group type: Experimental
  description: The index partner will participate in intervention as a dyad with a family member with an online skills training.
  intervention type: Behavioral
  intervention name: Together, Eating and Activity, Matter Plus (TEAM+) Online
  description: TEAM+ is a 3-month, family enhanced behavioral weight loss (BWL) intervention designed for Black adults consisting of an online family dyadic skills training and in-person core behavioral weight loss sessions.
  arm group label: Online Family Skills Training
  other name: TEAM +
  intervention type: Behavioral
  intervention name: Together, Eating and Activity, Matter Plus (TEAM+) In-Person
  description: TEAM+ is a 3-month, family enhanced behavioral weight loss (BWL) intervention designed for Black adults consisting of in-person family dyadic skills training and core behavioral weight loss sessions.
  arm group label: In-person Family Skills Training
  other name: TEAM +
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Candice Alick, PhD, MS
  role: Principal Investigator
  affiliation: University of North Carolina, Chapel Hill
  last name: Candice Alick, PhD, MS
  phone: 919-966-6080
  email: alick@email.unc.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Obesity
  mesh term: Overweight
  mesh term: Body Weight
  mesh term: Weight Loss
  mesh term: Chronic Disease
  mesh term: Body Weight Changes
  sharing ipd: Yes
  ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: beginning 9 and continuing for 36 months following publication
  ipd access criteria: Investigator has approved from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.