RECRUITING

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

Conditions

Obesity and Overweight Diabetes Mellitus Weight Loss Behavior Change weight loss program African American or Black families nutrition and physical activity behavior change

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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)

Quick Facts

Study Start:2025-01-15

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06724406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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)	* participation in an intensive weight loss program (more than 12 visits) in the prior 6 months * type 1 diabetes * significant psychiatric illness, defined as depression or other major psychiatric illness not considered reasonably managed by counseling, medication, or both * prior bariatric surgery or considering bariatric surgery in the next 6 months using or - - planning to start medications intentionally for weight loss * 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. * 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)

Inclusion Criteria

Exclusion Criteria

* 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)

* participation in an intensive weight loss program (more than 12 visits) in the prior 6 months
* type 1 diabetes
* significant psychiatric illness, defined as depression or other major psychiatric illness not considered reasonably managed by counseling, medication, or both
* prior bariatric surgery or considering bariatric surgery in the next 6 months using or - - planning to start medications intentionally for weight loss
* 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.
* 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)

Contacts and Locations

Study Contact

Carmen Samuel-Hodge

CONTACT

919-966-0360

cdsamuel@email.unc.edu

Principal Investigator

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

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Carmen Samuel-Hodge, PhD, MS, RD, LDN, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-15

Study Completion Date2028-07

Study Record Updates

Study Start Date2025-01-15

Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

weight loss program
African American or Black families
nutrition and physical activity behavior change

Additional Relevant MeSH Terms

Obesity and Overweight
Diabetes Mellitus
Weight Loss
Behavior Change