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Obesity and OverweightFAM WEL B-ingNCT06724406

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

A study testing Family Skills Training Session Quantity: 5, Family Skills Training Session Mode: In-person and Family Skills Training Content: Communication in people with Obesity and Overweight and Diabetes Mellitus, run by University of North Carolina, Chapel Hill at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Family Skills Training Session Quantity: 5, Family Skills Training Session Mode: In-person and Family Skills Training Content: Communication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteUnited States
Study dates
3 Feb 2025to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • able to make changes to the food you eat

Who cannot join

  • planning to move out of the area with the next 8-9 months
  • participation in an intensive weight loss program (more than 12 visits) in the prior 12 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 8-9 months
  • using or in the prior 3 months taking prescription weight loss medications, or planning to start medications intentionally for weight loss
Show all 12Show fewer
  • lost more than 20 pounds of body weight in last 6 months
  • are pregnant or planning to get pregnant in the next 8-9 months
  • are breastfeeding an infant less than 3 months old
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carmen Samuel-Hodge contact

919-966-0360

cdsamuel@email.unc.edu

United States1 site, 1 recruiting
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Recruiting

Other trials in United States

About this study

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)

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.

Read more

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
Read the 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.

Being tested
Family Skills Training Session Quantity: 5, Family Skills Training Session Mode: In-person, Family Skills Training Content: Communication, Family Skills Training Content: Cohesion, Family Skills Training Session Quantity: 10
Keywords
weight loss program, African American or Black families, nutrition and physical activity behavior change
Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Skills Training Session Quantity: 5Behavioural

    The number of family skills training sessions administered: 5 sessions

  • Family Skills Training Session Mode: In-personBehavioural

    The mode of administration of family skills training sessions: in person or online

  • Family Skills Training Content: CommunicationBehavioural

    The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution

  • Family Skills Training Content: CohesionBehavioural

    The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion

  • Family Skills Training Session Quantity: 10Behavioural

    The number of family skills training sessions administered: 10 sessions

  • Family Skills Training Session Mode: OnlineBehavioural

    The mode of administration of family skills training sessions: online

  • Family Skills Training Content: No CommunicationBehavioural

    The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution

  • Family Skills Training Content: No CohesionBehavioural

    The content of family skills training sessions administered focused on cohesion: no cohesion

Study groups in NCT06724406
Study groupRoleWhat they receive
Session 5, In-Person, Communication and CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion
Receives: 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
Session 5, In-Person, Communication and No CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion
Receives: 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: No Cohesion
Session 5, In-Person, Cohesion and No CommunicationExperimentalParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication
Receives: Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Cohesion
Session 5, In-Person, No Communication and No CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion
Receives: 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 Communication
Session 5, On-Line, Communication and CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion
Receives: Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Mode: Online
Session 5, On-Line, Communication and No CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion
Receives: Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Cohesion
Session 5, On-Line, Cohesion and No CommunicationExperimentalParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication
Receives: Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Communication
Session 5, On-Line, No Communication and No CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering no communication and no cohesion
Receives: Behavioral: Family Skills Training Session Quantity: 5; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Communication; Behavioral: Family Skills Training Content: No Cohesion
Session 10, In-Person, Communication and CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion
Receives: Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Quantity: 10
Session 10, In-Person, Communication and No CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion
Receives: Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Content: No Cohesion
Session 10, In-Person, Cohesion and No CommunicationExperimentalParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering cohesion but no no communication
Receives: Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Content: No Communication
Session 10, In-Person, No Communication and No CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering no communication and no cohesion
Receives: Behavioral: Family Skills Training Session Mode: In-person; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Content: No Communication; Behavioral: Family Skills Training Content: No Cohesion
Session 10, On-Line, Communication and CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion
Receives: Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Session Mode: Online
Session 10, On-Line, Communication and No CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion
Receives: Behavioral: Family Skills Training Content: Communication; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Cohesion
Session 10, On-Line, Cohesion and No CommunicationExperimentalParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication
Receives: Behavioral: Family Skills Training Content: Cohesion; Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Communication
Session 10, On-Line, No Communication and No CohesionExperimentalParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering no communication and no cohesion
Receives: Behavioral: Family Skills Training Session Quantity: 10; Behavioral: Family Skills Training Session Mode: Online; Behavioral: Family Skills Training Content: No Communication; Behavioral: Family Skills Training Content: No Cohesion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body weight

    Body weight (kg) expressed as a continuous variable will be collected on a digital scale.

    Measured: baseline and 6 months

Secondary outcomes (19)
  1. 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.

    Measured: baseline and 6 months

  2. 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.

    Measured: baseline and 6 months

  3. Change in physical activity steps

    To assess physical activity, the number of daily steps will be captured using a Fitbit wearable fitness tracker

    Measured: baseline and 6 months

  4. Change in glycosylated hemoglobin (A1c)

    Changes in A1c will be measured using a, Point of Contact A1c -Siemens Diabetes 5075 A1C Analyzer

    Measured: baseline and 6 months

  5. 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."

    Measured: baseline

  6. 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

    Measured: baseline and 6 months

  7. 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.

    Measured: baseline and 6 months

  8. 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.

    Measured: baseline and 6 months

  9. 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.

    Measured: baseline and 6 months

  10. 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.

    Measured: baseline and 6 months

  11. 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.

    Measured: baseline and 6 months

  12. 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;

    Measured: baseline and 6 months

  13. 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)

    Measured: baseline and 6 months

  14. 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

    Measured: baseline

  15. 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.

    Measured: baseline and 6 months

  16. 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.

    Measured: baseline and 6 months

  17. 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."

    Measured: baseline and 6 months

  18. 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."

    Measured: baseline and 6 months

  19. Personal Network Survey

    Social Network Analysis using Network Canvas software

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2024
  2. Study start3 Feb 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06724406
Sponsor's protocol ID
24-1302
Other IDs
R61HL169357
Acronym
FAM WEL B-ing
Status last verified
Sep 2026
First submitted
4 Dec 2024
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Family Skills Training Session Quantity: 5, Family Skills Training Session Mode: In-person and Family Skills Training Content: Communication in people with Obesity and Overweight and Diabetes Mellitus, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carmen Samuel-Hodge (919-966-0360, cdsamuel@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body weight (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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