Lifestyle Intervention + Stress Management for Obesity
(RESET Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking medications specifically for weight loss.
What data supports the effectiveness of the treatment Lifestyle Intervention + Stress Management for Obesity?
Is the Lifestyle Intervention + Stress Management for Obesity safe for humans?
The Diabetes Prevention Program Intensive Lifestyle Intervention (DPP-ILI) has been studied in diverse groups and shown to be safe for humans, focusing on diet and exercise to prevent diabetes. While specific safety data on the addition of stress management is not detailed, the core lifestyle intervention has been safely used in various populations.12367
How is the Lifestyle Intervention + Stress Management treatment for obesity unique compared to other treatments?
Research Team
Tiffany Carson, PhD
Principal Investigator
Moffitt Cancer Center
Eligibility Criteria
This trial is for adult black females with obesity, defined as a BMI of at least 30 kg/m^2, who are experiencing high stress levels. Participants should not be pregnant or planning pregnancy within the year, have no recent psychiatric hospitalizations, substance abuse issues, eating disorders, or medical conditions that would make weight loss unsafe.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a behavioral weight loss intervention with or without stress management for 26 sessions
Follow-up
Participants are monitored for weight change and stress levels after treatment
Treatment Details
Interventions
- Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
- Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator