NCT06724406 FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
| NCT ID | NCT06724406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Obesity and Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2025-02-03 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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)
Contact & Investigator
Carmen Samuel-Hodge, PhD, MS, RD, LDN
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06724406 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obesity and Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06724406 currently recruiting?
Yes, NCT06724406 is actively recruiting participants. Contact the research team at cdsamuel@email.unc.edu for enrollment information.
Where is the NCT06724406 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06724406 clinical trial?
NCT06724406 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Carmen Samuel-Hodge, PhD, MS, RD, LDN at University of North Carolina, Chapel Hill. The trial plans to enroll 256 participants.
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