FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Family Skills Training Session Quantity: 5, Family Skills Training Session Mode: In-person, Family Skills Training Content: Communication, Family Skills Training Content: Cohesion.
- Who it may be relevant to
- Registry conditions: Obesity and Overweight, Diabetes Mellitus, Weight Loss, Behavior Change. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing): Optimization and Evaluation Using Multiphase Optimization Strategy (MOST) and Social Network Analysis (SNA)
Overview
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
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.
Interventions
- Behavioral Family Skills Training Session Quantity: 5
The number of family skills training sessions administered: 5 sessions - Behavioral Family Skills Training Session Mode: In-person
The mode of administration of family skills training sessions: in person or online - Behavioral Family Skills Training Content: Communication
The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution - Behavioral Family Skills Training Content: Cohesion
The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion - Behavioral Family Skills Training Session Quantity: 10
The number of family skills training sessions administered: 10 sessions - Behavioral Family Skills Training Session Mode: Online
The mode of administration of family skills training sessions: online - 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 - Behavioral Family Skills Training Content: No Cohesion
The content of family skills training sessions administered focused on cohesion: no cohesion
Primary outcome measures
- Change in Body weight [Time frame: baseline and 6 months]
Secondary outcome measures (12)
- Mean Change in Blood Pressure [Time frame: baseline and 6 months]
- Change in skin carotenoids [Time frame: baseline and 6 months]
- Change in physical activity steps [Time frame: baseline and 6 months]
- Change in glycosylated hemoglobin (A1c) [Time frame: baseline and 6 months]
- Current Subjective Social Status [Time frame: baseline]
- Change in Quality of Life [Time frame: baseline and 6 months]
- Change in Depression [Time frame: baseline and 6 months]
- Change in Perceived stress [Time frame: baseline and 6 months]
- Change for social support for exercise [Time frame: baseline and 6 months]
- Change in Self-Efficacy of Eating Behaviors [Time frame: baseline and 6 months]
- Change in Self-Efficacy of Physical Activity [Time frame: baseline and 6 months]
- Changes in self-regulation [Time frame: baseline and 6 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill — Chapel Hill
Identifiers
NCT: NCT06724406 · 24-1302 · R61HL169357