MedTrace Logo

Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

NCT04335799 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2026-05-15

No results posted yet for this study

Summary

The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.

Conditions

Interventions

BEHAVIORAL

Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

12-month evidence based weight loss intervention with additional training on stress management strategies

BEHAVIORAL

Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics

12-month evidence based weight loss intervention with an attention control of general women's health topics

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Tiffany L Carson, PhD · Moffitt Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2026-04-14
Completion
2027-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04335799 on ClinicalTrials.gov