Recruiting

FAM WEL B-ing

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06724406

Conditions

Obesity and Overweight

Diabetes Mellitus

Weight Loss

Behavior Change

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Family Skills Training Session Quantity: 5

Family Skills Training Session Mode: In-person

Family Skills Training Content: Communication

Family Skills Training Content: Cohesion

Family Skills Training Session Quantity: 10

Study Details

Brief summary:

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

Conditions

Obesity and Overweight

Diabetes Mellitus

Weight Loss

Behavior Change

Study ID

NCT06724406

Start date

Feb 3, 2025

Status verified date

Aug, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • self-identified as Black or African American (Index participant)
  • BMI equal to greater than 30 kg/m\^2 (Index); BMI equal to greater than 27.5 kg/m\^2 (family partner)
  • have a partner/family member willing to enroll in the study and must share a mutual goal of achieving weight loss
  • English speaking
  • ages 18-75
  • any gender
  • have access to and be able to use a smartphone, tablet, or computer that has web-access (this is required for data collection and some program components being tested)

Exclusion Criteria:

  • participation in an intensive weight loss program (more than 12 visits) in the prior 6 months
  • type 1 diabetes
  • significant psychiatric illness, defined as depression or other major psychiatric illness not considered reasonably managed by counseling, medication, or both
  • had bariatric surgery (surgery for weight loss) in the last 2 years or considering bariatric surgery in the next 6 months
  • using or planning to start medications intentionally for weight loss
  • are pregnant or planning to get pregnant in the next 6 months
  • are breastfeeding and less than 2 months postpartum
  • alcohol or substance abuse, defined as alcohol or substance use that interferes with work activities and/or has had a major negative impact on family/social function, the latter defined as more than 2 episodes per month.
  • malignancy other than non-melanoma skin cancer, unless considered cured > 5 years ago. Exceptions include 1) men with localized prostate cancer (treated with usual modalities or managed with "active surveillance"), and 2) postmenopausal women receiving adjuvant endocrine therapy (e.g., aromatase inhibitor) for non-metastatic, hormone receptor-positive breast cancer
  • self-report of advanced kidney disease (estimated glomerular filtration rate (GFR) < 30 mL/min)

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Family Skills Training Session Quantity: 5

The number of family skills training sessions administered: 5 sessions

Family Skills Training Session Mode: In-person

The mode of administration of family skills training sessions: in person or online

Family Skills Training Content: Communication

The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution

Family Skills Training Content: Cohesion

The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion

Family Skills Training Session Quantity: 10

The number of family skills training sessions administered: 10 sessions

Family Skills Training Session Mode: Online

The mode of administration of family skills training sessions: online

Family Skills Training Content: No Communication

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

The content of family skills training sessions administered focused on cohesion: no cohesion

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Carmen Samuel-Hodge

919-966-0360cdsamuel@email.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Keywords

  • weight loss program
  • African American or Black families
  • nutrition and physical activity behavior change

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-08-29.