FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
Recruiting · NCT06724406 · Interventional (participants receive a specific treatment) · Lead sponsor: University of North Carolina, Chapel Hill
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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)
Where it is running
1 location listed across 1 US state.
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States