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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54CA153719 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study.
Using a cluster-randomized study design, 400 overweight or obese African American women living in 8 rural counties in Alabama and Mississippi associated with the Deep South Network for Cancer Control will be assigned to either a weight loss only or weight loss plus community strategies condition for 2 years.
Weight Loss Only condition: In year 1, participants will attend weekly in-person group sessions (1.5 hours each) aimed at behavioral changes for weight loss (diet and physical activity) for 6 months followed by twice a month meetings for 3 months, then monthly meetings for 3 months. In year 2, monthly phone calls will be used to encourage continued behavior change or weight maintenance. In-person group meetings will be facilitated by a trained lay staff and community health advisors. Monthly phone calls will be conducted by the community health advisor.
Weight Loss Plus Community Strategies condition: Participants will receive the same weight loss program as the Weight Loss Only condition. In addition, a community-based organization or other non-profit group in the targeted community will receive funds and technical assistance to implement community-wide efforts to increase access to healthy affordable food and safe and convenient opportunities for physical activity (e.g., increase farmer's markets, develop walking trails).
Over the course of the study, participants will complete four full assessments to include measurement of height and weight (to calculate BMI), waist circumference, blood pressure, finger-stick blood draw for lipid and glucose testing, dietary recall, and questionnaires concerning participation in physical activity, self-efficacy for eating and exercise behaviors, depressive symptoms, perceived stress, social support, and demographic information (e.g., age, marital status, education, employment, household income).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss Only | Active Comparator | 24- month weight loss program (year 1: weekly in-person meetings for 6 months, followed by 2 meetings per month for 3 months, then monthly for 3 months; year 2: monthly phone calls) |
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| Weight Loss Plus | Experimental | Same intervention as "Weight Loss Only" but includes community-wide interventions to increase access to healthy affordable food and opportunities for safe and convenient physical activity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss Only | Behavioral | Participants will attend in-person weekly sessions (about 1.5 hours each) for 6 months and then twice a month for 3 months and monthly for 3 months. Sessions focus on behavioral techniques supporting healthy diet (including calorie restriction for weight loss) and achieving recommended amounts of physical activity per week. During 1-year weight loss maintenance, participants receive monthly motivational phone calls. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Measured weight (nearest kg) | baseline to 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference | Measured circumference (nearest cm) | baseline to 6-months |
| Blood Pressure | Measured blood pressure (mmHG) - systolic and diastolic |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Weight Loss Plus | Behavioral | Participants attend in-person meetings as described above. This condition also includes community-wide strategies to increase access to healthy affordable food and safe opportunities for physical activity. |
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| baseline to 6-months |
| Lipids | Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio | baseline to 6-months |
| Weight | Measured weight (nearest kg) | baseline to 12-months |
| Weight | Measured weight (nearest kg) | baseline to 24-months |
| Social Support for Healthy Eating and Exercise | Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated. | baseline to 6-months |
| Social Support for Healthy Eating and Exercise | Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated. | baseline to 12-months |
| Social Support Healthy Eating and Exercise | Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated. | baseline to 24-months |
| Self Efficacy for Healthy Eating and Exercise | Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated. | baseline to 6-months |
| Self Efficacy for Healthy Eating and Exercise | Self-report | baseline to 12-months |
| Self Efficacy for Healthy Eating and Exercise | Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated. | baseline to 24-months |
| Dietary Intake | 24 hour recall | baseline to 6-months |
| Dietary Intake | 24 hour recall | baseline to 12-months |
| Dietary Intake | 24 hour recall | baseline to 24-months |
| Perceived Stress Scale | Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses. | baseline to 6-months |
| Perceived Stress Scale | Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses. | baseline to 12-months |
| Perceived Stress Scale | Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses. | baseline to 24-months |