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.
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
- Conditions the study is for
- Obesity and Overweight, Diabetes Mellitus, Weight Loss
- What is being tested?
- Family Skills Training Session Quantity: 5, Family Skills Training Session Mode: In-person and Family Skills Training Content: Communication
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
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 group | Role | What they receive |
|---|---|---|
| Session 5, In-Person, Communication and Cohesion | Experimental | Participants 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 Cohesion | Experimental | Participants 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 Communication | Experimental | Participants 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 Cohesion | Experimental | 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 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 Cohesion | Experimental | Participants 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 Cohesion | Experimental | Participants 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 Communication | Experimental | Participants 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 Cohesion | Experimental | 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 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 Cohesion | Experimental | Participants 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 Cohesion | Experimental | Participants 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 Communication | Experimental | 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 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 Cohesion | Experimental | 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 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 Cohesion | Experimental | Participants 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 Cohesion | Experimental | Participants 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 Communication | Experimental | Participants 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 Cohesion | Experimental | 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 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted9 Dec 2024
- Study start3 Feb 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Carmen Samuel-Hodge, PhD, MS, RD, LDN, Principal investigator, University of North Carolina, Chapel Hill
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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06724406
- Acronym / sponsor ID
- FAM WEL B-ing / 24-1302
- Keywords
- weight loss program, African American or Black families, nutrition and physical activity behavior change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Session 5, In-Person, Communication and Cohesion | Experimental | 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: CohesionParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion |
| Session 5, In-Person, Communication and No Cohesion | Experimental | 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 CohesionParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion |
| Session 5, In-Person, Cohesion and No Communication | Experimental | Behavioral: Family Skills Training Session Quantity: 5, Behavioral: Family Skills Training Session Mode: In-person, Behavioral: Family Skills Training Content: CohesionParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication |
| Session 5, In-Person, No Communication and No Cohesion | Experimental | 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 CommunicationParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion |
| Session 5, On-Line, Communication and Cohesion | Experimental | 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: OnlineParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion |
| Session 5, On-Line, Communication and No Cohesion | Experimental | 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 CohesionParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion |
| Session 5, On-Line, Cohesion and No Communication | Experimental | 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 CommunicationParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication |
| Session 5, On-Line, No Communication and No Cohesion | Experimental | 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 CohesionParticipants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering no communication and no cohesion |
| Session 10, In-Person, Communication and Cohesion | Experimental | 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: 10Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion |
| Session 10, In-Person, Communication and No Cohesion | Experimental | 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 CohesionParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion |
| Session 10, In-Person, Cohesion and No Communication | Experimental | 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 CommunicationParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering cohesion but no no communication |
| Session 10, In-Person, No Communication and No Cohesion | Experimental | 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 CohesionParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering no communication and no cohesion |
| Session 10, On-Line, Communication and Cohesion | Experimental | 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: OnlineParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion |
| Session 10, On-Line, Communication and No Cohesion | Experimental | 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 CohesionParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion |
| Session 10, On-Line, Cohesion and No Communication | Experimental | 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 CommunicationParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication |
| Session 10, On-Line, No Communication and No Cohesion | Experimental | 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 CohesionParticipants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering no communication and no cohesion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Skills Training Session Quantity: 5The number of family skills training sessions administered: 5 sessions | Behavioural | Session 5, In-Person, Cohesion and No Communication, Session 5, In-Person, Communication and Cohesion, Session 5, In-Person, Communication and No Cohesion, Session 5, In-Person, No Communication and No Cohesion, Session 5, On-Line, Cohesion and No Communication, Session 5, On-Line, Communication and Cohesion, Session 5, On-Line, Communication and No Cohesion, Session 5, On-Line, No Communication and No Cohesion |
| Family Skills Training Session Mode: In-personThe mode of administration of family skills training sessions: in person or online | Behavioural | Session 10, In-Person, Cohesion and No Communication, Session 10, In-Person, Communication and Cohesion, Session 10, In-Person, Communication and No Cohesion, Session 10, In-Person, No Communication and No Cohesion, Session 5, In-Person, Cohesion and No Communication, Session 5, In-Person, Communication and Cohesion, Session 5, In-Person, Communication and No Cohesion, Session 5, In-Person, No Communication and No Cohesion |
| Family Skills Training Content: CommunicationThe content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution | Behavioural | Session 10, In-Person, Communication and Cohesion, Session 10, In-Person, Communication and No Cohesion, Session 10, On-Line, Communication and Cohesion, Session 10, On-Line, Communication and No Cohesion, Session 5, In-Person, Communication and Cohesion, Session 5, In-Person, Communication and No Cohesion, Session 5, In-Person, No Communication and No Cohesion, Session 5, On-Line, Communication and Cohesion, Session 5, On-Line, Communication and No Cohesion |
| Family Skills Training Content: CohesionThe content of family skills training sessions administered focused on cohesion: cohesion or no cohesion | Behavioural | Session 10, In-Person, Cohesion and No Communication, Session 10, In-Person, Communication and Cohesion, Session 10, On-Line, Cohesion and No Communication, Session 10, On-Line, Communication and Cohesion, Session 5, In-Person, Cohesion and No Communication, Session 5, In-Person, Communication and Cohesion, Session 5, In-Person, No Communication and No Cohesion, Session 5, On-Line, Cohesion and No Communication, Session 5, On-Line, Communication and Cohesion |
| Family Skills Training Session Quantity: 10The number of family skills training sessions administered: 10 sessions | Behavioural | Session 10, In-Person, Cohesion and No Communication, Session 10, In-Person, Communication and Cohesion, Session 10, In-Person, Communication and No Cohesion, Session 10, In-Person, No Communication and No Cohesion, Session 10, On-Line, Cohesion and No Communication, Session 10, On-Line, Communication and Cohesion, Session 10, On-Line, Communication and No Cohesion, Session 10, On-Line, No Communication and No Cohesion |
| Family Skills Training Session Mode: OnlineThe mode of administration of family skills training sessions: online | Behavioural | Session 10, On-Line, Cohesion and No Communication, Session 10, On-Line, Communication and Cohesion, Session 10, On-Line, Communication and No Cohesion, Session 10, On-Line, No Communication and No Cohesion, Session 5, On-Line, Cohesion and No Communication, Session 5, On-Line, Communication and Cohesion, Session 5, On-Line, Communication and No Cohesion, Session 5, On-Line, No Communication and No Cohesion |
| Family Skills Training Content: No CommunicationThe content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution | Behavioural | Session 10, In-Person, Cohesion and No Communication, Session 10, In-Person, No Communication and No Cohesion, Session 10, On-Line, Cohesion and No Communication, Session 10, On-Line, No Communication and No Cohesion, Session 5, In-Person, No Communication and No Cohesion, Session 5, On-Line, Cohesion and No Communication, Session 5, On-Line, No Communication and No Cohesion |
| Family Skills Training Content: No CohesionThe content of family skills training sessions administered focused on cohesion: no cohesion | Behavioural | Session 10, In-Person, Communication and No Cohesion, Session 10, In-Person, No Communication and No Cohesion, Session 10, On-Line, Communication and No Cohesion, Session 10, On-Line, No Communication and No Cohesion, Session 5, In-Person, Communication and No Cohesion, Session 5, On-Line, Communication and No Cohesion, Session 5, On-Line, No Communication and No Cohesion |
Primary outcome
Change in Body weight
Time frame: baseline and 6 months
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
19 secondary outcomes
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
Changes in nutrition self-efficacy
Time frame: baseline and 6 months
Physical Activity Readiness
Time frame: baseline
Change in Family Emotional Involvement
Time frame: baseline and 6 months
Change in Family Perceived Criticism
Time frame: baseline and 6 months
Change in Family Collaborative problem solving
Time frame: baseline and 6 months
Change in Family Cohesion
Time frame: baseline and 6 months
Personal Network Survey
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carmen Samuel-Hodge, PhD, MS, RD, LDN principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
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.