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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01321 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB00011637 | Other Identifier | OHSU Knight Cancer Institute | |
| P30CA069533 | U.S. NIH Grant/Contract | View source | |
| R03CA197657 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
This pilot clinical trial studies how well an evidence-based exercise and nutrition program adapted for Latinas works in improving physical activity and dietary behavior in non-active, overweight, or obese rural Latinas. An exercise and nutrition program may reduce the risk for developing certain cancers, obesity, and chronic health conditions in Latinas who are non-active, overweight, or obese.
PRIMARY OBJECTIVES:
I. Adapt an effective evidence-based exercise and nutrition program to meet the needs of rural Latinas.
II. Implement the adapted program in a rural Latina population. III. Evaluate feasibility and potential to improve physical activity and dietary behavior of the adapted program in a rural Latina population.
OUTLINE:
Phase I: Create a community advisory board to adapt Strong Women Healthy Hearts Program (SWHHP) using feedback on the existing SWHHP from Latinas residing in the community.
Phase II: Conduct a small pilot study to assess effectiveness of the adapted program (one group pre-post design, with data collected at three time points).
INTERVENTION GROUP: Participants undergo instructor-led exercise and nutrition education classes for 60 minutes each twice a week for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (exercise, nutrition education program) | Experimental | Exercise Intervention & Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Undergo instructor-led exercise program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Mean and standard deviation will be calculated. | Baseline up to post intervention, up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fitness level as assessed by the 6 minute walk test | The distance walked in 6 minutes will be recorded. Mean and standard deviation will be calculated. | Baseline up to post intervention, up to 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Perry | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Nutritional Intervention | Behavioral | Undergo instructor-led nutritional education program |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |