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

FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing): Optimization and Evaluation Using Multiphase Optimization Strategy (MOST) and Social Network Analysis (SNA)

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Weight Loss; Behavior Change; Obesity and Overweight
• Intervention / Treatment: Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Content: No Cohesion; Behavioral: Family Skills Training Content: No Communication; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Session Quantity: 10

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.

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Samuel-Hodge; Phone Number: 919-966-0360; Email: cdsamuel@email.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Session 5, In-Person, Communication and Cohesion; Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion	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
Experimental: Session 5, In-Person, Communication and No Cohesion; Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion	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: No Cohesion; The content of family skills training sessions administered focused on cohesion: no cohesion
Experimental: Session 5, In-Person, Cohesion and No Communication; Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication	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: Cohesion; The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion
Experimental: Session 5, In-Person, No Communication and No Cohesion; Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion	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 Content: No Communication; The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution
Experimental: Session 5, On-Line, Communication and Cohesion; Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion	Behavioral: Family Skills Training Session Quantity: 5; The number of family skills training sessions administered: 5 sessions; 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 Mode: Online; The mode of administration of family skills training sessions: online
Experimental: Session 5, On-Line, Communication and No Cohesion; Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion	Behavioral: Family Skills Training Session Quantity: 5; The number of family skills training sessions administered: 5 sessions; 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: No Cohesion; The content of family skills training sessions administered focused on cohesion: no cohesion; Behavioral: Family Skills Training Session Mode: Online; The mode of administration of family skills training sessions: online
Experimental: Session 5, On-Line, Cohesion and No Communication; Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication	Behavioral: Family Skills Training Session Quantity: 5; The number of family skills training sessions administered: 5 sessions; 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 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 Session Mode: Online; The mode of administration of family skills training sessions: online
Experimental: Session 5, On-Line, No Communication and No Cohesion; Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering no communication and no cohesion	Behavioral: Family Skills Training Session Quantity: 5; The number of family skills training sessions administered: 5 sessions; Behavioral: Family Skills Training Content: No Cohesion; The content of family skills training sessions administered focused on cohesion: no cohesion; 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 Session Mode: Online; The mode of administration of family skills training sessions: online
Experimental: Session 10, In-Person, Communication and Cohesion; Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion	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
Experimental: Session 10, In-Person, Communication and No Cohesion; Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion	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: No Cohesion; The content of family skills training sessions administered focused on cohesion: no cohesion; Behavioral: Family Skills Training Session Quantity: 10; The number of family skills training sessions administered: 10 sessions
Experimental: Session 10, In-Person, Cohesion and No Communication; Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering cohesion but no no communication	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: Cohesion; The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion; 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 Session Quantity: 10; The number of family skills training sessions administered: 10 sessions
Experimental: Session 10, In-Person, No Communication and No Cohesion; Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering no communication and no cohesion	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: No Cohesion; The content of family skills training sessions administered focused on cohesion: no cohesion; 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 Session Quantity: 10; The number of family skills training sessions administered: 10 sessions
Experimental: Session 10, On-Line, Communication and Cohesion; Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion	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 Mode: Online; The mode of administration of family skills training sessions: online; Behavioral: Family Skills Training Session Quantity: 10; The number of family skills training sessions administered: 10 sessions
Experimental: Session 10, On-Line, Communication and No Cohesion; Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion	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: No Cohesion; The content of family skills training sessions administered focused on cohesion: no cohesion; Behavioral: Family Skills Training Session Mode: Online; The mode of administration of family skills training sessions: online; Behavioral: Family Skills Training Session Quantity: 10; The number of family skills training sessions administered: 10 sessions
Experimental: Session 10, On-Line, Cohesion and No Communication; Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication	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 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 Session Mode: Online; The mode of administration of family skills training sessions: online; Behavioral: Family Skills Training Session Quantity: 10; The number of family skills training sessions administered: 10 sessions
Experimental: Session 10, On-Line, No Communication and No Cohesion; Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering no communication and no cohesion	Behavioral: Family Skills Training Content: No Cohesion; The content of family skills training sessions administered focused on cohesion: no cohesion; 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 Session Mode: Online; The mode of administration of family skills training sessions: online; Behavioral: Family Skills Training Session Quantity: 10; The number of family skills training sessions administered: 10 sessions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Blood Pressure	Both systolic and diastolic blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study.	baseline and 6 months
Change in skin carotenoids	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.	baseline and 6 months
Change in physical activity steps	To assess physical activity, the number of daily steps will be captured using a Fitbit wearable fitness tracker	baseline and 6 months
Change in glycosylated hemoglobin (A1c)	Changes in A1c will be measured using a, Point of Contact A1c -Siemens Diabetes 5075 A1C Analyzer	baseline and 6 months
Current Subjective Social Status	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."	baseline
Change in Quality of Life	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	baseline and 6 months
Change in Depression	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.	baseline and 6 months
Change in Perceived stress	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.	baseline and 6 months
Change for social support for exercise	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.	baseline and 6 months
Change in Self-Efficacy of Eating Behaviors	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.	baseline and 6 months
Change in Self-Efficacy of Physical Activity	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.	baseline and 6 months
Changes in self-regulation	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;	baseline and 6 months
Changes in nutrition self-efficacy	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)	baseline and 6 months
Physical Activity Readiness	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	baseline
Change in Family Emotional Involvement	The family emotional involvement (7 items) of the Family Emotional Involvement and Criticism Scale rate items on a 5-point Likert scale, as above.	baseline and 6 months
Change in Family Perceived Criticism	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.	baseline and 6 months
Change in Family Collaborative problem solving	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."	baseline and 6 months
Change in Family Cohesion	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."	baseline and 6 months
Personal Network Survey	Social Network Analysis using Network Canvas software	baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change for social support for eating	The Social Support and Eating Habits Survey (10 items) measures social support specific to healthy eating. Subscales assess encouragement for eating behaviors from partners (e.g., "Encouraged me not to eat 'unhealthy food' when I am tempted") and discouragement for eating behaviors from partners (e.g., "Brought home foods I am trying not to eat"). The items are rated on a scale of "none" to "very often." Total scores range from 5 to 50, with higher scores indicating more social support for eating behaviors.	baseline and 6 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Carmen Samuel-Hodge, PhD, MS, RD, LDN, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: weight loss program; African American or Black families; nutrition and physical activity behavior change
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss; Diabetes Mellitus
• Other Study ID Numbers: 24-1302; R61HL169357 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to preserve all the study data and to make it available to other researchers as appropriate, except that audio recordings of semi-structured interviews will NOT be made available, but the transcripts of these interviews will be made available. We do not plan to transcribe the fidelity audio recordings, so these data will not be made available. Our rationale for not sharing the audio recorded data is to minimize the risk of loss of confidentiality. All stored data are de-identified. Data will be made available no later than the time of an associated publication.
• IPD Sharing Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
• IPD Sharing Access Criteria: When data sharing is permitted, a Data Use Agreement (DUA) specifying the uses of such data to be shared must be in place before any data is shared. Requests can be submitted to the Industry Contracting for processing. The Principal Investigator must confirm that the DUA has been fully executed and IRB, IEC, or REB approval has been granted before sharing data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No