Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools
NCT ID: NCT04335799
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
341 participants
INTERVENTIONAL
2021-10-12
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Study Groups
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Weight Loss Plus Stress Management
Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training
Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training
12-month evidence based weight loss intervention with additional training on stress management strategies
Weight Loss Only
Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
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
Interventions
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Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training
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
12-month evidence based weight loss intervention with an attention control of general women's health topics
Eligibility Criteria
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Inclusion Criteria
* elevated stress levels based on perceived stress scale score
* self-identified as black race
Exclusion Criteria
* 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
21 Years
75 Years
FEMALE
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Tiffany L Carson, PhD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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References
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Buro AW, Baskin M, Miller D, Ward T, West DS, Gore LR, Gwede CK, Epel E, Carson TL. Rationale and study protocol for a randomized controlled trial to determine the effectiveness of a culturally relevant, stress management enhanced behavioral weight loss intervention on weight loss outcomes of black women. BMC Public Health. 2022 Jan 28;22(1):193. doi: 10.1186/s12889-022-12519-z.
Related Links
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Moffitt Cancer Center Clinical Trials website
Other Identifiers
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MCC-21236
Identifier Type: -
Identifier Source: org_study_id
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