Clinical trial NCT06724406: FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Diabetes Mellitus
Weight Loss
Behavior Change
Keywords: weight loss program
African American or Black families
nutrition and physical activity behavior change
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-12-09
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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.

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
* prior bariatric surgery or considering bariatric surgery in the next 6 months using or - - planning to start medications intentionally for weight loss
* pregnancy/breastfeeding or intended pregnancy in the next 6 months
* 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)

Primary outcomes:
measure: Change in Body weight
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Mean Change in Blood Pressure
timeFrame: baseline and 6 months
measure: Change in skin carotenoids
timeFrame: baseline and 6 months
measure: Change in physical activity steps
timeFrame: baseline and 6 months
measure: Change in glycosylated hemoglobin (A1c)
timeFrame: baseline and 6 months
measure: Current Subjective Social Status
timeFrame: baseline
measure: Change in Quality of Life
timeFrame: baseline and 6 months
measure: Change in Depression
timeFrame: baseline and 6 months
measure: Change in Perceived stress
timeFrame: baseline and 6 months
measure: Change for social support for exercise
timeFrame: baseline and 6 months
measure: Change in Self-Efficacy of Eating Behaviors
timeFrame: baseline and 6 months
measure: Change in Self-Efficacy of Physical Activity
timeFrame: baseline and 6 months
measure: Changes in self-regulation
timeFrame: baseline and 6 months
measure: Changes in nutrition self-efficacy
timeFrame: baseline and 6 months
measure: Physical Activity Readiness
timeFrame: baseline
measure: Change in Family Emotional Involvement
timeFrame: baseline and 6 months
measure: Change in Family Perceived Criticism
timeFrame: baseline and 6 months
measure: Change in Family Collaborative problem solving
timeFrame: baseline and 6 months
measure: Change in Family Cohesion
timeFrame: baseline and 6 months
measure: Personal Network Survey
timeFrame: baseline
Other outcomes:
measure: Change for social support for eating
timeFrame: baseline and 6 months
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmen Samuel-Hodge, PhD, MS, RD, LDN
role: PRINCIPAL_INVESTIGATOR
References: