Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools (RESET)

H. Lee Moffitt Cancer Center and Research Institute

Status: Active, not recruiting

Conditions: Obesity

Treatments: Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics; Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04335799

MCC-21236

R01DK125367 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 341 patients

Sex: Female

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI of at least 30 kg/m^2
• elevated stress levels based on perceived stress scale score
• self-identified as black race

Exclusion criteria

• pregnant or are planning to become pregnant in the next year
• known major medical or psychological condition known to influence body weight loss (e.g., medicated or poorly controlled diabetes (fasting blood glucose > 126 mg/dL), cardiovascular event in the preceding 12 months, history of gastric bypass surgery, bariatric surgery, or eating disorder)
• history of psychiatric hospitalization in past 2 years
• history of substance abuse or eating disorder
• any condition for which a medical professional has suggested diet modification, physical activity, and/or weight reduction would be contraindicated.
• currently taking medications for weight loss

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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341 participants in 2 patient groups

Weight Loss Plus Stress Management

Experimental group

Description:

Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training

Treatment:

Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

Weight Loss Only

Active Comparator group

Description:

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

Treatment:

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