RESET: Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Weight Loss Plus Stress Management Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training |
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
|
| Active Comparator: Weight Loss Only Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics |
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
|
Outcome Measures
Primary Outcome Measures
- 4-month mean weight change of participants using SECA scale [Baseline to Month 4]
weight change as measured by a SECA scale in kilograms and baseline and month 4 will be calculated and averaged
- 12-month mean weight change of participants using SECA scale [Baseline to Month 12]
weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged
Secondary Outcome Measures
- mean change in perceived stress using Perceived Stress Scale-10 score [Baseline to Month 4]
Perceived stress as measured with a validated survey will be assessed at baseline and month to assess changes in participant's stress
- mean change in perceived stress using Perceived Stress Scale-10 score [Baseline to Month 12]
Perceived stress as measured with a validated survey will be assessed at baseline and month 12 to assess changes in participant's stress
Eligibility Criteria
Criteria
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)
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history of psychiatric hospitalization in past 2 years
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history of substance abuse or eating disorder
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any condition for which a medical professional has suggested diet modification, physical activity, and/or weight reduction would be contraindicated.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Tiffany L Carson, PhD, Moffitt Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MCC-21236
- R01DK125367