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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK125367 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss Plus Stress Management | Experimental | Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training |
|
| Weight Loss Only | Active Comparator | Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 4-month mean weight change of participants using SECA scale | weight change as measured by a SECA scale in kilograms and baseline and month 4 will be calculated and averaged | Baseline to Month 4 |
| 12-month mean weight change of participants using SECA scale | weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged | Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| mean change in perceived stress using Perceived Stress Scale-10 score | Perceived stress as measured with a validated survey will be assessed at baseline and month to assess changes in participant's stress | Baseline to Month 4 |
| mean change in perceived stress using Perceived Stress Scale-10 score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany L Carson, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35090433 | Derived | 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. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| 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 |
|
Perceived stress as measured with a validated survey will be assessed at baseline and month 12 to assess changes in participant's stress |
| Baseline to Month 12 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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