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

NCT06724406 | Recruiting DMC

• 2 other identifiers: 24-1302R61HL169357
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Body weight

  Body weight (kg) expressed as a continuous variable will be collected on a digital scale.

  baseline and 6 months

Secondary Outcomes (19)

• Mean Change in Blood Pressure

  baseline and 6 months

• Change in skin carotenoids

  baseline and 6 months

• Change in physical activity steps

  baseline and 6 months

• Change in glycosylated hemoglobin (A1c)

  baseline and 6 months

• Current Subjective Social Status

  baseline

Other Outcomes (1)

• Change for social support for eating

  baseline and 6 months

Study Arms (16)

Session 5, In-Person, Communication and Cohesion

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion

Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Content: Cohesion

Session 5, In-Person, Communication and No Cohesion

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion

Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Content: No Cohesion

Session 5, In-Person, Cohesion and No Communication

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication

Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Cohesion

Session 5, In-Person, No Communication and No Cohesion

EXPERIMENTAL

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

Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Content: No Communication

Session 5, On-Line, Communication and Cohesion

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion

Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Mode: Online

Session 5, On-Line, Communication and No Cohesion

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion

Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Cohesion

Session 5, On-Line, Cohesion and No Communication

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication

Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Communication

Session 5, On-Line, No Communication and No Cohesion

EXPERIMENTAL

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

Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Communication; Behavioral: Family Skills Training Content: No Cohesion

Session 10, In-Person, Communication and Cohesion

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion

Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Quantity: 10

Session 10, In-Person, Communication and No Cohesion

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion

Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Content: No Cohesion

Session 10, In-Person, Cohesion and No Communication

EXPERIMENTAL

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

Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Content: No Communication

Session 10, In-Person, No Communication and No Cohesion

EXPERIMENTAL

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

Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Content: No Communication; Behavioral: Family Skills Training Content: No Cohesion

Session 10, On-Line, Communication and Cohesion

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion

Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Session Mode: Online

Session 10, On-Line, Communication and No Cohesion

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion

Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Cohesion

Session 10, On-Line, Cohesion and No Communication

EXPERIMENTAL

Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication

Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Communication

Session 10, On-Line, No Communication and No Cohesion

EXPERIMENTAL

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

Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Communication; Behavioral: Family Skills Training Content: No Cohesion

Interventions

Family Skills Training Session Quantity: 5 BEHAVIORAL

The number of family skills training sessions administered: 5 sessions

Session 5, In-Person, Cohesion and No Communication; Session 5, In-Person, Communication and Cohesion; Session 5, In-Person, Communication and No Cohesion; Session 5, In-Person, No Communication and No Cohesion; Session 5, On-Line, Cohesion and No Communication; Session 5, On-Line, Communication and Cohesion; Session 5, On-Line, Communication and No Cohesion; Session 5, On-Line, No Communication and No Cohesion

Family Skills Training Session Mode: In-person BEHAVIORAL

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

Session 10, In-Person, Cohesion and No Communication; Session 10, In-Person, Communication and Cohesion; Session 10, In-Person, Communication and No Cohesion; Session 10, In-Person, No Communication and No Cohesion; Session 5, In-Person, Cohesion and No Communication; Session 5, In-Person, Communication and Cohesion; Session 5, In-Person, Communication and No Cohesion; Session 5, In-Person, No Communication and No Cohesion

Family Skills Training Content: Communication BEHAVIORAL

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

Session 10, In-Person, Communication and Cohesion; Session 10, In-Person, Communication and No Cohesion; Session 10, On-Line, Communication and Cohesion; Session 10, On-Line, Communication and No Cohesion; Session 5, In-Person, Communication and Cohesion; Session 5, In-Person, Communication and No Cohesion; Session 5, In-Person, No Communication and No Cohesion; Session 5, On-Line, Communication and Cohesion; Session 5, On-Line, Communication and No Cohesion

Family Skills Training Content: Cohesion BEHAVIORAL

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

Session 10, In-Person, Cohesion and No Communication; Session 10, In-Person, Communication and Cohesion; Session 10, On-Line, Cohesion and No Communication; Session 10, On-Line, Communication and Cohesion; Session 5, In-Person, Cohesion and No Communication; Session 5, In-Person, Communication and Cohesion; Session 5, In-Person, No Communication and No Cohesion; Session 5, On-Line, Cohesion and No Communication; Session 5, On-Line, Communication and Cohesion

Family Skills Training Session Quantity: 10 BEHAVIORAL

The number of family skills training sessions administered: 10 sessions

Session 10, In-Person, Cohesion and No Communication; Session 10, In-Person, Communication and Cohesion; Session 10, In-Person, Communication and No Cohesion; Session 10, In-Person, No Communication and No Cohesion; Session 10, On-Line, Cohesion and No Communication; Session 10, On-Line, Communication and Cohesion; Session 10, On-Line, Communication and No Cohesion; Session 10, On-Line, No Communication and No Cohesion

Family Skills Training Session Mode: Online BEHAVIORAL

The mode of administration of family skills training sessions: online

Session 10, On-Line, Cohesion and No Communication; Session 10, On-Line, Communication and Cohesion; Session 10, On-Line, Communication and No Cohesion; Session 10, On-Line, No Communication and No Cohesion; Session 5, On-Line, Cohesion and No Communication; Session 5, On-Line, Communication and Cohesion; Session 5, On-Line, Communication and No Cohesion; Session 5, On-Line, No Communication and No Cohesion

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

Session 10, In-Person, Cohesion and No Communication; Session 10, In-Person, No Communication and No Cohesion; Session 10, On-Line, Cohesion and No Communication; Session 10, On-Line, No Communication and No Cohesion; Session 5, In-Person, No Communication and No Cohesion; Session 5, On-Line, Cohesion and No Communication; Session 5, On-Line, No Communication and No Cohesion

Family Skills Training Content: No Cohesion BEHAVIORAL

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

Session 10, In-Person, Communication and No Cohesion; Session 10, In-Person, No Communication and No Cohesion; Session 10, On-Line, Communication and No Cohesion; Session 10, On-Line, No Communication and No Cohesion; Session 5, In-Person, Communication and No Cohesion; Session 5, On-Line, Communication and No Cohesion; Session 5, On-Line, No Communication and No Cohesion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Study Officials

• Carmen Samuel-Hodge, PhD, MS, RD, LDN

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Samuel-Hodge

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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 the University of North Carolina.
• Access Criteria: When data sharing is permitted, a Data Use Agreement (DUA) specifying the uses of such data to be shared must be in place before any data is shared. Requests can be submitted to the Industry Contracting for processing. The Principal Investigator must confirm that the DUA has been fully executed and IRB, IEC, or REB approval has been granted before sharing data.

Locations

US (1)