Family Skills Training for Obesity

(FAM WEL B-ing Trial)

Overseen By Carmen Samuel-Hodge

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Weight loss drugs

Disqualifiers: Type 1 diabetes, Psychiatric illness, Bariatric surgery, Pregnancy, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

256 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best combination of family-focused strategies to help Black adults lose weight effectively. It examines various combinations of family skills, such as communication and bonding, alongside a standard weight loss program called FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing). Participants will engage in both group and family sessions to monitor their weight, diet, and activity levels. This trial suits Black adults with a BMI over 30 and a family member willing to join the weight loss journey. As an unphased trial, it provides a unique opportunity to contribute to innovative weight loss strategies tailored for Black families.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using or planning to start medications specifically for weight loss, you may not be eligible to participate.

What prior data suggests that this family skills training program is safe for weight loss among Black adults?

Research has shown that family-centered weight loss programs, such as the FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing) program, have been used with Black adults before. These programs aid weight loss by involving family members in the process.

Previous studies of similar programs have found that participants generally handle them well, with no reports of serious side effects or problems. This suggests that joining a program focused on family skills and behavior changes is likely safe.

This trial is in the "Not Applicable" phase, indicating it does not test a new drug or device. Instead, it focuses on finding the best way to support weight loss through family involvement, which is typically a low-risk approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Skills Training for Obesity trial because it explores how family dynamics, like communication and cohesion, impact weight loss, a relatively new angle in obesity treatment. Unlike traditional weight loss programs that focus primarily on individual behavior changes or medication, this trial tests whether enhancing family interactions can boost weight loss outcomes, particularly for Black adults. By comparing in-person and online sessions, the trial also examines the flexibility and accessibility of delivering these interventions. This approach might reveal powerful insights into how family support can play a critical role in obesity management, potentially leading to more tailored and effective weight loss strategies.

What evidence suggests that this trial's treatments could be effective for weight loss among Black adults?

Research has shown that involving family can greatly aid weight loss. Family-focused weight loss programs succeed by addressing both behavior and environment, crucial factors in managing weight. Past programs for Black adults succeeded by incorporating family support and communication. Early results suggest that families working together create a supportive environment that fosters healthy habits. This trial will test various treatment arms, each with different combinations of family skills training sessions, to identify the best approach for weight loss. Participants will experience varying levels of focus on communication and cohesion, both in-person and online, to determine the most effective strategy. ^{1 2 3 4 6}

Who Is on the Research Team?

Carmen Samuel-Hodge, PhD, MS, RD, LDN

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for Black adults looking to lose weight, possibly with obesity or diabetes. Participants will join a 6-month program involving group sessions and family-based activities focusing on communication and cohesion. They must be willing to track their diet, physical activity, and weight changes.

Inclusion Criteria

Self-identified as Black or African American (Index participant)

English speaking

I have a partner or family member ready to join the study with me to lose weight.

Exclusion Criteria

I have had or am considering weight loss surgery soon and might start weight loss medications.

Pregnancy/breastfeeding or intended pregnancy in the next 6 months

Alcohol or substance abuse, defined as alcohol or substance use that interferes with work activities and/or has had a major negative impact on family/social function, the latter defined as more than 2 episodes per month

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-month behavioral weight loss intervention, including group sessions and family-based dyad sessions, tracking weight, dietary intake, and physical activity

24 weeks

Multiple in-person and online sessions

Follow-up

Participants are monitored for changes in body weight, blood pressure, and other health metrics

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests which combination of family skills training (communication, cohesion) alongside standard weight loss programs works best for Black adults. It varies the number of sessions (5 or 10) and delivery mode (in-person or online).

How Is the Trial Designed?

Group I: Session 5, On-Line, No Communication and No Cohesion Experimental Treatment 4 Interventions

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

Group II: Session 5, On-Line, Communication and No Cohesion Experimental Treatment 4 Interventions

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion

Group III: Session 5, On-Line, Communication and Cohesion Experimental Treatment 4 Interventions

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion

Group IV: Session 5, On-Line, Cohesion and No Communication Experimental Treatment 4 Interventions

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication

Group V: Session 5, In-Person, No Communication and No Cohesion Experimental Treatment 5 Interventions

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

Group VI: Session 5, In-Person, Communication and No Cohesion Experimental Treatment 4 Interventions

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion

Group VII: Session 5, In-Person, Communication and Cohesion Experimental Treatment 4 Interventions

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion

Group VIII: Session 5, In-Person, Cohesion and No Communication Experimental Treatment 3 Interventions

Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication

Group IX: Session 10, On-Line, No Communication and No Cohesion Experimental Treatment 4 Interventions

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

Group X: Session 10, On-Line, Communication and No Cohesion Experimental Treatment 4 Interventions

Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion

Group XI: Session 10, On-Line, Communication and Cohesion Experimental Treatment 4 Interventions

Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion

Group XII: Session 10, On-Line, Cohesion and No Communication Experimental Treatment 4 Interventions

Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication

Group XIII: Session 10, In-Person, No Communication and No Cohesion Experimental Treatment 4 Interventions

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

Group XIV: Session 10, In-Person, Communication and No Cohesion Experimental Treatment 4 Interventions

Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion

Group XV: Session 10, In-Person, Communication and Cohesion Experimental Treatment 4 Interventions

Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion

Group XVI: Session 10, In-Person, Cohesion and No Communication Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A family-based weight-loss intervention for underserved African American families revealed significant secondary benefits, particularly in cognitive outcomes like self-regulation and goal-setting, as reported by both adolescents and parents.

Parents highlighted social benefits such as family support and communication, while adolescents focused on positive family interactions, indicating that these programs can enhance overall well-being beyond just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary benefits of the families improving together (FIT) for weight loss trial on cognitive and social factors in African American adolescents. Sweeney, AM., Wilson, DK., Loncar, H., et al.[2022]

A study involving 136 African American adolescents and their caregivers found that most participants found the family-based weight loss intervention helpful, particularly in terms of program practices and content.

Despite overall satisfaction, participants highlighted challenges with session logistics and expressed a desire for more engaging, tailored content, including exercise sessions and skills-based learning, indicating areas for improvement in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an Evidence-Based Weight Loss Trial for Urban African American Adolescents and Caregivers. Campbell-Voytal, K., Hartlieb, KB., Cunningham, PB., et al.[2023]

A family-centered behavioral weight loss intervention for African American adults with type 2 diabetes resulted in a significant average weight loss of 5.0 kg among participants in the intervention group compared to a weight gain of 1.4 kg in the control group after 20 weeks.

The intervention not only improved weight loss but also led to better management of diabetes (as indicated by lower hemoglobin A1c levels), reduced depressive symptoms, and enhanced family interactions and self-care behaviors related to diet and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family PArtners in Lifestyle Support (PALS): Family-based weight loss for African American adults with type 2 diabetes. Samuel-Hodge, CD., Holder-Cooper, JC., Gizlice, Z., et al.[2022]

In a 2-year trial involving 193 African American adults, those who enrolled in a weight loss program with family or friends lost more weight than those who enrolled alone, with family participants losing about 5-6 kg compared to 3-4 kg for individuals.

However, the overall social support level (high vs low) did not significantly impact weight loss outcomes, indicating that the effectiveness of social support may depend more on the active participation and success of partners rather than just their presence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of family and friend support for weight loss in African American adults. Kumanyika, SK., Wadden, TA., Shults, J., et al.[2022]

A study involving 66 middle-aged overweight and obese African American women revealed a strong interest in receiving social support for weight loss, particularly focused on health benefits.

Participants identified supportive behaviors such as exercising together, providing nutrition education, using positive reinforcement, and avoiding criticism as key elements for effective weight loss support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support needs of overweight African American women for weight loss. Thomas, JL., Stewart, DW., Lynam, IM., et al.[2022]

Familial factors, both genetic and environmental, significantly influence obesity and the effectiveness of weight loss treatments, highlighting the importance of family dynamics in health maintenance practices.

The family-oriented weight control program incorporates nutrition, behavior change, exercise, and support systems, using 'skill builders' to help families address specific challenges related to diet and exercise, ultimately promoting healthier lifestyles for all family members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity a family matter: creating new behavior. Frankle, RT.[2004]

In a study of 49 obese diabetic patients, those who participated in a weight control program alone lost an average of 19.9 pounds, while those who attended with their spouses lost 19.1 pounds, showing no significant difference in overall weight loss.

However, the results indicated that women benefited more from the family-based approach, while men had better outcomes when participating alone, suggesting that treatment strategies may need to be tailored based on gender.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A "family-based" approach to the treatment of obese type II diabetic patients. Wing, RR., Marcus, MD., Epstein, LH., et al.[2019]

A systematic review of 25 studies on behavioral weight loss interventions for African-American women found that more intensive and well-designed trials yield better weight loss results, especially in medically at-risk populations.

Despite these interventions, African-American women tend to lose less weight compared to other groups, highlighting the need to address biological, social, and environmental factors that contribute to obesity in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss and African-American women: a systematic review of the behavioural weight loss intervention literature. Fitzgibbon, ML., Tussing-Humphreys, LM., Porter, JS., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11090859

RePORT RePORTER - National Institutes of Health (NIH) | Our research team has previously developed and implemented family-centered behavioral weight loss interventions for Black adults, including both couples and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06724406

FAMily-centered WEight Loss for Black Adults (FAM WEL B ... The goal of this clinical trial is to learn the best combination of family components that yields optimal weight loss among Black adults.

3. hpdp.unc.edu hpdp.unc.edu/famwelbeing/

FAMily-centered WEight Loss for Black Adults (FAM WEL ... The research study aims to identify the best combination of family-centered components to optimize weight loss outcomes among Black adults.

4. trialx.com trialx.com/clinical-trials/listings/305538/family-centered-weight-loss-for-black-adults-fam-wel-b-ing/?&radius=50

FAMily-centered WEight Loss for Black Adults (FAM WEL B ... This clinical trial aims to determine the most effective combination of family components to achieve optimal weight loss among Black adults.

5. hpdp.unc.edu hpdp.unc.edu/current-research/family-centered-weight-loss-for-black-adults-fam-wel-b-ing-optimization-and-evaluation-using-multiphase-optimization-strategy-most-and-social-network-analysis-sna/

FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing) This study works to optimize these interventions. In this study, researchers will recruit Black adult family dyads, who will receive a version of the core ...

6. withpower.com withpower.com/trial/phase-overweight-10-2024-5b388

Family Skills Training for Obesity (FAM WEL B-ing Trial) The goal of this clinical trial is to learn the best combination of family components that yields optimal weight loss among Black adults.