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This study tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama.
This is a 3-arm cluster randomized controlled study that compares a trained lay provided weight loss program vs. the same program plus community-based weight management strategies vs. general cancer prevention education on weight loss and other clinical outcomes (primary outcomes) and healthy behaviors, and psychosocial functioning (secondary outcomes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss Only | Active Comparator | Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (~5-10% of baseline weight). |
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| Weight Loss Plus | Experimental | Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (~5-10% of baseline weight) plus community-level strategies to support healthy weight. Strategies are based on CDC's recommended community strategies and are developed by local contractors. They include expanded farmers markets/gardens, improvement to walking trails, etc. |
|
| Control | Active Comparator | Educational materials and optional participation in community-wide cancer awareness activities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss Only | Behavioral | 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) |
| 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 24 months |
| Lipids | Measured total cholesterol, triglycerides, HDL, LDL, ratio (mg/dL) |
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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 |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single Blind (Participant)
| Weight Loss Plus | 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. |
|
| Control | Behavioral | Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions. |
|
| Baseline to 24 months |
| Blood Pressure | Measured blood pressure (mmHG) - systolic and diastolic | Baseline to 24 months |
| Weight | Measured weight (nearest kg) | Baseline to 12 months |
| Weight | Measured weight (nearest kg) | Baseline to 24 months |
| Social Support for Diet and Exercise Behaviors | self report measure of social support (family, friend) in performing diet and exercise behaviors | Baseline to 6 months |
| Social Support for Diet and Exercise Behaviors | self report measure of social support (family, friend) in performing diet and exercise behaviors | Baseline to 12 months |
| Social Support for Diet and Exercise Behaviors | self report measure of social support (family, friend) in performing diet and exercise behaviors | Baseline to 24 months |
| Self Efficacy for Diet and Exercise Behaviors | self report measure of confidence in performing diet and exercise behaviors | Baseline to 6 months |
| Self Efficacy for Diet and Exercise Behaviors | self report measure of confidence in performing diet and exercise behaviors | Baseline to 12 months |
| Self Efficacy for Diet and Exercise Behaviors | self report measure of confidence in performing diet and exercise behaviors | Baseline to 24 months |
| Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) | self report measure of dietary intake | Baseline to 6 months |
| Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) | self report measure of dietary intake | Baseline to 12 months |
| Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) | self report measure of dietary intake | Baseline to 24 months |