FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06724406
Status
Recruiting
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Conditions

  • Behavior Change
  • Diabetes Mellitus
  • Obesity and Overweight
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Family Skills Training Session Quantity: 5 — BEHAVIORAL
    The number of family skills training sessions administered: 5 sessions
  • Family Skills Training Session Mode: In-person — BEHAVIORAL
    The mode of administration of family skills training sessions: in person or online
  • Family Skills Training Content: Communication — BEHAVIORAL
    The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution
  • Family Skills Training Content: Cohesion — BEHAVIORAL
    The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion
  • Family Skills Training Session Quantity: 10 — BEHAVIORAL
    The number of family skills training sessions administered: 10 sessions
  • Family Skills Training Session Mode: Online — BEHAVIORAL
    The mode of administration of family skills training sessions: online
  • Family Skills Training Content: No Communication — BEHAVIORAL
    The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution
  • Family Skills Training Content: No Cohesion — BEHAVIORAL
    The content of family skills training sessions administered focused on cohesion: no cohesion

Study Details

The goal of this clinical trial is to learn the best combination of family components that yields optimal weight loss among Black adults. The main question it aims to answer is: What combination of four family components in combination with a standard behavioral weight loss program yields optimal weight loss among Black adults? Researchers will compare different combinations of family skills components (communication content, cohesion content, number of sessions, and mode of delivery) to see the best weight loss. Participants will: * Participate in a 6-month behavioral weight loss intervention * Attend core weight loss in-person group sessions, and dyad based family sessions * Keep track of weight, dietary intake and physical activity

Key Dates

Start date
Feb 3, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Session 5, In-Person, Communication and Cohesion
    Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion
  • Experimental: Session 5, In-Person, Communication and No Cohesion
    Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion
  • Experimental: Session 5, In-Person, Cohesion and No Communication
    Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication
  • Experimental: Session 5, In-Person, No Communication and No Cohesion
    Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion
  • Experimental: Session 5, On-Line, Communication and Cohesion
    Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion
  • Experimental: Session 5, On-Line, Communication and No Cohesion
    Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion
  • Experimental: Session 5, On-Line, Cohesion and No Communication
    Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication
  • Experimental: Session 5, On-Line, No Communication and No Cohesion
    Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering no communication and no cohesion
  • Experimental: Session 10, In-Person, Communication and Cohesion
    Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion
  • Experimental: Session 10, In-Person, Communication and No Cohesion
    Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion
  • Experimental: Session 10, In-Person, Cohesion and No Communication
    Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering cohesion but no no communication
  • Experimental: Session 10, In-Person, No Communication and No Cohesion
    Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering no communication and no cohesion
  • Experimental: Session 10, On-Line, Communication and Cohesion
    Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion
  • Experimental: Session 10, On-Line, Communication and No Cohesion
    Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion
  • Experimental: Session 10, On-Line, Cohesion and No Communication
    Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication
  • Experimental: Session 10, On-Line, No Communication and No Cohesion
    Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering no communication and no cohesion

Primary Outcome Measure

Change in Body weight [ Time Frame: baseline and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-

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