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Behavioural Intervention

Family Skills Training for Obesity (FAM WEL B-ing Trial)

N/A
Waitlist Available
Led By Carmen Samuel-Hodge, PhD, MS, RD, LDN
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-75
Be older than 18 years old
Must not have
Participation in an intensive weight loss program (more than 12 visits) in the prior 6 months
Type 1 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find out the best way to help Black adults lose weight by involving their families. Researchers want to know how different family components, like communication and group sessions, can help with weight loss

Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
Since this trial involves behavioral changes rather than medication, side effects may include discomfort from lifestyle adjustments such as dietary restrictions or increased exercise rather than typical drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been part of a weight loss program with over 12 visits in the last 6 months.
Select...
I have Type 1 diabetes.
Select...
My psychiatric condition is not well-controlled with medication or counseling.
Select...
My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Body weight
Secondary study objectives
Change for social support for exercise
Change in Depression
Change in Family Cohesion
+16 more
Other study objectives
Change for social support for eating

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups
Experimental Treatment
Group I: Session 5, On-Line, No Communication and No CohesionExperimental Treatment4 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 CohesionExperimental Treatment4 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 CohesionExperimental Treatment4 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 CommunicationExperimental Treatment4 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 CohesionExperimental Treatment5 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 CohesionExperimental Treatment4 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 CohesionExperimental Treatment4 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 CommunicationExperimental Treatment3 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 CohesionExperimental Treatment4 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 CohesionExperimental Treatment4 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 CohesionExperimental Treatment4 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 CommunicationExperimental Treatment4 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 CohesionExperimental Treatment4 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 CohesionExperimental Treatment4 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 CohesionExperimental Treatment4 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 CommunicationExperimental Treatment4 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

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,451 Total Patients Enrolled
66 Trials studying Obesity
58,444 Patients Enrolled for Obesity
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,576 Total Patients Enrolled
255 Trials studying Obesity
211,420 Patients Enrolled for Obesity
Carmen Samuel-Hodge, PhD, MS, RD, LDNPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
~171 spots leftby Jul 2028