NCT05981508

Brief Summary

The purpose of this research study is to test the feasibility and acceptability of an interactive counselor -led online family skills training as part of a behavioral weight loss program for Black Adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 6, 2025

Completed
Last Updated

November 6, 2025

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

July 31, 2023

Results QC Date

June 30, 2025

Last Update Submit

October 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Body Weight

    Body weight (kg) expressed as a continuous variable will be collected on a digital scale.

    Baseline, 12 weeks

Secondary Outcomes (11)

  • Change in Body Mass Index (BMI)

    Baseline,12 weeks

  • Change in Self-Regulation of Eating Behaviors

    Baseline,12 weeks

  • Change in Self-Efficacy of Eating Behaviors

    Baseline,12 weeks

  • Change in Social Support Effectiveness

    Baseline,12 weeks

  • Change in Social Support for Eating

    Baseline,12 weeks

  • +6 more secondary outcomes

Study Arms (2)

In-person Family Skills Training

ACTIVE COMPARATOR

The index partner will participate in intervention as a dyad with a family member with an in-person skills training.

Behavioral: Together, Eating and Activity, Matter Plus (TEAM+) In-Person

Online Family Skills Training

EXPERIMENTAL

The index partner will participate in intervention as a dyad with a family member with an online skills training.

Behavioral: Together, Eating and Activity, Matter Plus (TEAM+) Online

Interventions

TEAM+ is a 3-month, family enhanced behavioral weight loss (BWL) intervention designed for Black adults consisting of an online family dyadic skills training and in-person core behavioral weight loss sessions.

Also known as: TEAM +
Online Family Skills Training

TEAM+ is a 3-month, family enhanced behavioral weight loss (BWL) intervention designed for Black adults consisting of in-person family dyadic skills training and core behavioral weight loss sessions.

Also known as: TEAM +
In-person Family Skills Training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self-identify as a Black or African American,
  • are between 18-75 years old
  • have a family member willing to attend study session with you
  • have Internet access
  • reside in the Raleigh/Durham/Chapel Hill area,

You may not qualify if:

  • not interested in losing weight
  • have any conditions affecting weight
  • currently receiving cancer treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health Promotion and Disease Prevention

Chapel Hill, North Carolina, 27499, United States

Location

MeSH Terms

Conditions

Body WeightBody Weight ChangesObesityOverweightFeeding BehaviorSedentary BehaviorChronic DiseaseWeight Loss

Interventions

EatingExercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBehavior, AnimalBehaviorDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Candice L. Alick, PhD
Organization
Morehouse School of Medicine

Study Officials

  • Candice Alick, PhD, MS

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 8, 2023

Study Start

February 5, 2024

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

November 6, 2025

Results First Posted

November 6, 2025

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
beginning 9 and continuing for 36 months following publication
Access Criteria
Investigator has approved from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations