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

NCT ID: NCT06724406

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2028-12-31

Brief Summary

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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

Detailed Description

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This clinical trial aims to determine the most effective combination of family components to achieve optimal weight loss among Black adults. The main focus is to assess how different combinations of four family skills components-communication content, cohesion content, number of sessions, and mode of delivery-work together with a standard behavioral weight loss program.

Participants will engage in a 6-month behavioral weight loss intervention, which includes attending group weight loss sessions and family-based dyad sessions. They will also track their weight, dietary intake, and physical activity.

This is a 2 x4 factorial design with 16 study conditions.

Conditions

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Obesity and Overweight Diabetes Mellitus Weight Loss Behavior Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Family Skills Training Session Quantity: 5

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 5 sessions

Family Skills Training Session Mode: In-person

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Communication

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Cohesion

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Family Skills Training Session Quantity: 5

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 5 sessions

Family Skills Training Session Mode: In-person

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Communication

Intervention Type BEHAVIORAL

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

Family Skills Training Content: No Cohesion

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Family Skills Training Session Quantity: 5

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 5 sessions

Family Skills Training Session Mode: In-person

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Cohesion

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Family Skills Training Session Quantity: 5

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 5 sessions

Family Skills Training Session Mode: In-person

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Communication

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Cohesion

Intervention Type BEHAVIORAL

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

Family Skills Training Content: No Communication

Intervention Type BEHAVIORAL

The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution

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

Group Type EXPERIMENTAL

Family Skills Training Session Quantity: 5

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 5 sessions

Family Skills Training Content: Communication

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Cohesion

Intervention Type BEHAVIORAL

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

Family Skills Training Session Mode: Online

Intervention Type BEHAVIORAL

The mode of administration of family skills training sessions: online

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

Group Type EXPERIMENTAL

Family Skills Training Session Quantity: 5

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 5 sessions

Family Skills Training Content: Communication

Intervention Type BEHAVIORAL

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

Family Skills Training Session Mode: Online

Intervention Type BEHAVIORAL

The mode of administration of family skills training sessions: online

Family Skills Training Content: No Cohesion

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Family Skills Training Session Quantity: 5

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 5 sessions

Family Skills Training Content: Cohesion

Intervention Type BEHAVIORAL

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

Family Skills Training Session Mode: Online

Intervention Type BEHAVIORAL

The mode of administration of family skills training sessions: online

Family Skills Training Content: No Communication

Intervention Type BEHAVIORAL

The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution

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

Group Type EXPERIMENTAL

Family Skills Training Session Quantity: 5

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 5 sessions

Family Skills Training Session Mode: Online

Intervention Type BEHAVIORAL

The mode of administration of family skills training sessions: online

Family Skills Training Content: No Communication

Intervention Type 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

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Family Skills Training Session Mode: In-person

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Communication

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Cohesion

Intervention Type BEHAVIORAL

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

Family Skills Training Session Quantity: 10

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 10 sessions

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

Group Type EXPERIMENTAL

Family Skills Training Session Mode: In-person

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Communication

Intervention Type BEHAVIORAL

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

Family Skills Training Session Quantity: 10

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 10 sessions

Family Skills Training Content: No Cohesion

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Family Skills Training Session Mode: In-person

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Cohesion

Intervention Type BEHAVIORAL

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

Family Skills Training Session Quantity: 10

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 10 sessions

Family Skills Training Content: No Communication

Intervention Type BEHAVIORAL

The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution

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

Group Type EXPERIMENTAL

Family Skills Training Session Mode: In-person

Intervention Type BEHAVIORAL

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

Family Skills Training Session Quantity: 10

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 10 sessions

Family Skills Training Content: No Communication

Intervention Type 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

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Family Skills Training Content: Communication

Intervention Type BEHAVIORAL

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

Family Skills Training Content: Cohesion

Intervention Type BEHAVIORAL

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

Family Skills Training Session Quantity: 10

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 10 sessions

Family Skills Training Session Mode: Online

Intervention Type BEHAVIORAL

The mode of administration of family skills training sessions: online

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

Group Type EXPERIMENTAL

Family Skills Training Content: Communication

Intervention Type BEHAVIORAL

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

Family Skills Training Session Quantity: 10

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 10 sessions

Family Skills Training Session Mode: Online

Intervention Type BEHAVIORAL

The mode of administration of family skills training sessions: online

Family Skills Training Content: No Cohesion

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Family Skills Training Content: Cohesion

Intervention Type BEHAVIORAL

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

Family Skills Training Session Quantity: 10

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 10 sessions

Family Skills Training Session Mode: Online

Intervention Type BEHAVIORAL

The mode of administration of family skills training sessions: online

Family Skills Training Content: No Communication

Intervention Type BEHAVIORAL

The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution

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

Group Type EXPERIMENTAL

Family Skills Training Session Quantity: 10

Intervention Type BEHAVIORAL

The number of family skills training sessions administered: 10 sessions

Family Skills Training Session Mode: Online

Intervention Type BEHAVIORAL

The mode of administration of family skills training sessions: online

Family Skills Training Content: No Communication

Intervention Type 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

Intervention Type BEHAVIORAL

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

Interventions

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Family Skills Training Session Quantity: 5

The number of family skills training sessions administered: 5 sessions

Intervention Type BEHAVIORAL

Family Skills Training Session Mode: In-person

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

Intervention Type BEHAVIORAL

Family Skills Training Content: Communication

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

Intervention Type BEHAVIORAL

Family Skills Training Content: Cohesion

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

Intervention Type BEHAVIORAL

Family Skills Training Session Quantity: 10

The number of family skills training sessions administered: 10 sessions

Intervention Type BEHAVIORAL

Family Skills Training Session Mode: Online

The mode of administration of family skills training sessions: online

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Family Skills Training Content: No Cohesion

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carmen Samuel-Hodge

Role: CONTACT

919-966-0360

Other Identifiers

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R61HL169357

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1302

Identifier Type: -

Identifier Source: org_study_id

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