FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of North Carolina, Chapel Hill
About 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
self-identified as Black or African American (Index participant)
BMI equal to greater than 30 kg/m² (Index); BMI equal to greater than 27.5 kg/m² (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
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Family Skills Training Session Quantity: 5
BehavioralThe number of family skills training sessions administered: 5 sessions
Family Skills Training Session Mode: In-person
BehavioralThe mode of administration of family skills training sessions: in person or online
Family Skills Training Content: Communication
BehavioralThe content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution
Family Skills Training Content: Cohesion
BehavioralThe content of family skills training sessions administered focused on cohesion: cohesion or no cohesion
Family Skills Training Session Quantity: 10
BehavioralThe number of family skills training sessions administered: 10 sessions
Family Skills Training Session Mode: Online
BehavioralThe mode of administration of family skills training sessions: online
Family Skills Training Content: No Communication
BehavioralThe content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution
Family Skills Training Content: No Cohesion
BehavioralThe content of family skills training sessions administered focused on cohesion: no cohesion
Treatment groups
256 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: Session 5, In-Person, Communication and CohesionExperimental treatment 4 interventions
Group B: Session 5, In-Person, Communication and No CohesionExperimental treatment 4 interventions
Group C: Session 5, In-Person, Cohesion and No CommunicationExperimental treatment 3 interventions
Group D: Session 5, In-Person, No Communication and No CohesionExperimental treatment 5 interventions
Group E: Session 5, On-Line, Communication and CohesionExperimental treatment 4 interventions
Group F: Session 5, On-Line, Communication and No CohesionExperimental treatment 4 interventions
Group G: Session 5, On-Line, Cohesion and No CommunicationExperimental treatment 4 interventions
Group H: Session 5, On-Line, No Communication and No CohesionExperimental treatment 4 interventions
Group I: Session 10, In-Person, Communication and CohesionExperimental treatment 4 interventions
Group J: Session 10, In-Person, Communication and No CohesionExperimental treatment 4 interventions
Group K: Session 10, In-Person, Cohesion and No CommunicationExperimental treatment 4 interventions
Group L: Session 10, In-Person, No Communication and No CohesionExperimental treatment 4 interventions
Group M: Session 10, On-Line, Communication and CohesionExperimental treatment 4 interventions
Group N: Session 10, On-Line, Communication and No CohesionExperimental treatment 4 interventions
Group O: Session 10, On-Line, Cohesion and No CommunicationExperimental treatment 4 interventions
Group P: Session 10, On-Line, No Communication and No CohesionExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Change in Body weight
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
Time frame
baseline and 6 monthsSecondary outcomes
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.
Time frame
baseline and 6 months2
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.
Time frame
baseline and 6 months3
Change in physical activity steps
To assess physical activity, the number of daily steps will be captured using a Fitbit wearable fitness tracker
Time frame
baseline and 6 months4
Change in glycosylated hemoglobin (A1c)
Changes in A1c will be measured using a, Point of Contact A1c -Siemens Diabetes 5075 A1C Analyzer
Time frame
baseline and 6 monthsOther outcomes
1
Change for social support for eating
The Social Support and Eating Habits Survey (10 items) measures social support specific to healthy eating. Subscales assess encouragement for eating behaviors from partners (e.g., "Encouraged me not to eat 'unhealthy food' when I am tempted") and discouragement for eating behaviors from partners (e.g., "Brought home foods I am trying not to eat"). The items are rated on a scale of "none" to "very often." Total scores range from 5 to 50, with higher scores indicating more social support for eating behaviors.
Time frame
baseline and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov