Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools
- Conditions
- Obesity
- Registration Number
- NCT04335799
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 340
- BMI of at least 30 kg/m^2
- elevated stress levels based on perceived stress scale score
- self-identified as black race
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Moffitt Cancer Center🇺🇸Tampa, Florida, United StatesAlissa PenaContact813-745-7710Alissa.Pena@moffitt.orgJazmin HendersonContact813-745-5588Jazmin.Henderson@moffitt.orgTiffany Carson, PhDPrincipal Investigator