FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)

Not Applicable

Not yet recruiting

• Conditions: Obesity and Overweight; Diabetes Mellitus; Weight Loss; Behavior Change

• Registration Number: NCT06724406
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-29
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 256

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in Body weight	baseline and 6 months	Body weight (kg) expressed as a continuous variable will be collected on a digital scale.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Blood Pressure	baseline and 6 months	Both systolic and diastolic blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study.
Change in skin carotenoids	baseline and 6 months	To assess fruit and vegetable intake, skin carotenoids will be measured using a reflection spectroscopy device ("Veggie Meter") The Veggie Meter uses reflection spectroscopy and a light-emitting diode (LED) light to measure the skin's carotenoids on a scale of 0 to 800. Higher scores indicate more carotenoids, which usually means the person has eaten more fruits and vegetables.
Change in physical activity steps	baseline and 6 months	To assess physical activity, the number of daily steps will be captured using a Fitbit wearable fitness tracker
Change in glycosylated hemoglobin (A1c)	baseline and 6 months	Changes in A1c will be measured using a, Point of Contact A1c -Siemens Diabetes 5075 A1C Analyzer
Current Subjective Social Status	baseline	Assesses a person's perceived rank relative to others in their group. The MacArthur Scale of Subjective Social Status (MacArthur SSS Scale) is a single-item measure that assesses a person's perceived rank relative to others in their group. Respondents view a drawing of a ladder with 10 rungs, and either read or hear that the ladder represents where people stand in society. Respondents further read or hear: "At the top of the ladder are the people who are the best off, those who have the most money, most education, and best jobs. At the bottom are the people who are the worst off, those who have the least money, least education, worst jobs, or no job. To score this measure, researchers simply note the number of the rung (1-10) on which the respondent placed their "X."
Change in Quality of Life	baseline and 6 months	12-Item Short Form Survey (SF-12) assessing the impact of health on an individual's everyday life. The 12-Item Short Form Survey (SF-12) is scored by calculating two main scores: a Physical Component Summary (PCS) and a Mental Component Summary (MCS), both ranging from 0 to 100, with higher scores indicating better physical and mental health respectively
Change in Depression	baseline and 6 months	Patient Health Questionnaire -8 (PHQ-8). To score the Patient Health Questionnaire-8 (PHQ-8), add up the scores from each of the eight items, with each item rated on a scale from 0 ("not at all") to 3 ("nearly every day") - resulting in a total score ranging from 0 to 24; higher scores indicate greater depression severity; generally, a score of 10 or higher is considered clinically significant for major depression, while scores between 5-9 are considered mild depression and 10-14 moderate depression.
Change in Perceived stress	baseline and 6 months	Measured using Perceived Stress Scale 4 (PSS-4). On the Perceived Stress Scale 4 (PSS-4), each question is scored on a 0-4 scale, with higher scores indicating greater perceived stress, and the total score is calculated by adding up all four items; the possible score range for the PSS-4 is therefore 0-16, with higher scores signifying higher levels of stress.
Change for social support for exercise	baseline and 6 months	The exercise participation subscale of the Social Support and Exercise Survey (10 items) measures social support specific to exercise behaviors. The subscale assesses the level of support for exercise from partners. Subscale example items include "Exercised with me" and "Criticized or made fun of me for exercising." Total scores range from 5 to 50, with higher scores indicating more social support for exercise participation behaviors.
Change in Self-Efficacy of Eating Behaviors	baseline and 6 months	Measured by survey responses to the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF).Scale goes from 0 (not at all confident) to 10 (very confident). Higher scores mean better self efficacy.
Change in Self-Efficacy of Physical Activity	baseline and 6 months	The confidence subscale of the Patient-centered Assessment and Counseling for Exercise Adult Diet and Physical Activity Measure (6 items; ) measures confidence in participating in regular exercise or physical activity in different situations (e.g., "How confident are you that you would participate in regular exercise or physical activity: When I am tired?"). Items rated on a scale from 1 ("not at all confident") to 6 ("extremely confident"). Higher scores show higher self-efficacy.
Changes in self-regulation	baseline and 6 months	Treatment Self-Regulation Questionnaire. To score the Treatment Self-Regulation Questionnaire (TSRQ), each item is typically rated on a 7-point Likert scale, where 1 represents "Not at all true" and 7 represents "Very true," with higher scores indicating a greater degree of autonomous motivation for engaging in the targeted health behavior;
Changes in nutrition self-efficacy	baseline and 6 months	Nutrition Self-efficacy scale (5 items). To score a 5-item Nutrition Self-Efficacy scale, typically each item is rated on a Likert scale (usually 1-5, with 1 being "not at all confident" and 5 being "very confident"), and then the scores from all five items are added together to produce a total score, with higher scores indicating greater perceived self-efficacy in managing nutrition choices; the total score range would be between 5 (lowest self-efficacy) and 25 (highest self-efficacy)
Physical Activity Readiness	baseline	PHYSICAL ACTIVITY READINESS QUESTIONNAIRE (PAR-Q) \& You. The Physical Activity Readiness Questionnaire (PAR-Q) is a seven-question screening tool that helps determine if a person is healthy enough to exercise. If you answer "yes" to one or more questions, you should consult a physician before starting an exercise program
Change in Family Emotional Involvement	baseline and 6 months	The family emotional involvement (7 items) of the Family Emotional Involvement and Criticism Scale rate items on a 5-point Likert scale, as above.
Change in Family Perceived Criticism	baseline and 6 months	The perceived criticism (7 items) subscales of the Family Emotional Involvement and Criticism Scale rate items like on a 5-point Likert scale, as above.
Change in Family Collaborative problem solving	baseline and 6 months	The Family Problem-Solving Communication Index (10 items) was used to measure the specific communication style that families use to manage and solve problems and conflicts in various types of stressful situations. Consisting of 2 subscales, affirmatory communication and incendiary communication, the response options were "false," "mostly false," "mostly true," and "true."
Change in Family Cohesion	baseline and 6 months	The cohesion subscale (10 items) of the Family Adaptability and Cohesion Evaluation Scale III measures the emotional bonding family members have with one another. Items like "Family members ask each other for help" rated on a 5-point Likert scale from "almost never" to "almost always."
Personal Network Survey	baseline	Social Network Analysis using Network Canvas software

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States