FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
NCT ID: NCT06724406
Last Updated: 2025-08-29
Study Results
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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RECRUITING
NA
256 participants
INTERVENTIONAL
2025-02-03
2028-12-31
Brief Summary
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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
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Detailed Description
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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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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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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
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
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
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: No Cohesion
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
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: Cohesion
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
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 Content: No Communication
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
Family Skills Training Session Quantity: 5
The number of family skills training sessions administered: 5 sessions
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 Mode: Online
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
Family Skills Training Session Quantity: 5
The number of family skills training sessions administered: 5 sessions
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 Session Mode: Online
The mode of administration of family skills training sessions: online
Family Skills Training Content: No Cohesion
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
Family Skills Training Session Quantity: 5
The number of family skills training sessions administered: 5 sessions
Family Skills Training Content: Cohesion
The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion
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
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
Family Skills Training Session Quantity: 5
The number of family skills training sessions administered: 5 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
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
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
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
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 Session Quantity: 10
The number of family skills training sessions administered: 10 sessions
Family Skills Training Content: No Cohesion
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
Family Skills Training Session Mode: In-person
The mode of administration of family skills training sessions: in person or online
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 Content: No Communication
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
Family Skills Training Session Mode: In-person
The mode of administration of family skills training sessions: in person or online
Family Skills Training Session Quantity: 10
The number of family skills training sessions administered: 10 sessions
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
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
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
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
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 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 Cohesion
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
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Other Identifiers
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24-1302
Identifier Type: -
Identifier Source: org_study_id
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