Family Skills Training for Obesity

(FAM WEL B-ing Trial)

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

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment FAM WEL B-ing for weight loss in Black adults?

Research shows that family-based weight loss programs can be helpful, especially for women, and that involving family and friends provides important social support. Participants in similar programs have found the involvement of family and the support from counselors beneficial, although they suggest improvements like more engaging activities and exercise sessions. ^{1 2 3 4 5}

Is the Family Skills Training for Obesity generally safe for humans?

The research on family-based weight loss programs, including those for African American adults with type 2 diabetes and adolescents, suggests that these interventions are generally safe and may offer additional health and social benefits beyond weight loss. ^{1 4 5 6 7}

What makes the FAM WEL B-ing treatment unique for weight loss in Black adults?

The FAM WEL B-ing treatment is unique because it focuses on family-centered support, involving family members in the weight loss process to provide culturally relevant social support, which can enhance motivation and retention in Black adults. ^{2 3 4 5 8}

Research Team

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

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

I am between 18 and 75 years old.

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

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

Trial Timeline

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

Treatment Details

Interventions

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

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).

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A "family-based" approach to the treatment of obese type II diabetic patients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an Evidence-Based Weight Loss Trial for Urban African American Adolescents and Caregivers. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Trial of family and friend support for weight loss in African American adults. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Family PArtners in Lifestyle Support (PALS): Family-based weight loss for African American adults with type 2 diabetes. [2022]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Weight loss and African-American women: a systematic review of the behavioural weight loss intervention literature. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Support needs of overweight African American women for weight loss. [2022]