Clinical trial

Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04335799

Active, not recruitingNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 75 Years

SexFemale

Healthy volunteersAccepted

ConditionObesity

Full registry 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) * 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

Treatments and study arms

Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

Behavioral

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

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

Behavioral

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

Primary outcomes

4-month mean weight change of participants using SECA scaleBaseline 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 scaleBaseline to Month 12

weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Moffitt Cancer Center🇺🇸 Tampa, Florida, United States

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