Promoting Weight-Loss in African American Cancer Survivors in the Deep South

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Conditions
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Weight Loss, Cancer

Intervention / Treatment
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* Behavioral: Weight Loss Only
* Behavioral: Weight Loss Plus
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American breast, colon, or prostate cancer survivor (Index Participant) Family member (support person) of African American breast, colon, or prostate cancer survivor (Family Member Participant) Live, work, or attend school in target county BMI >= 25 kg/m2 Exclusion Criteria: Pregnant or planning to become pregnant in the next year Known major medical or psychological condition known to influence body weight Uncontrolled hypertension (BP > 160 mmHg systolic or >100 mmHg diastolic) medicated or poorly controlled diabetes (glucose > 126) Cardiovascular event in the preceding 12 months History of gastric bypass or bariatric surgery History of psychiatric hospitalization in past 2 years History of substance abuse or eating disorder Any other condition by which a medical professional has suggested diet modification, physical activity and/or weight reduction would be contraindicated

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weight Loss Only<br>Group-based behavioral weight loss intervention designed to reach clinically significant weight loss ( 5-10% of baseline weight). | Behavioral: Weight Loss Only<br>* 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)<br>|
| Experimental: Weight Loss Plus<br>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. | Behavioral: Weight Loss Plus<br>* 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.<br>|
| Active Comparator: Control<br>Educational materials and optional participation in community-wide cancer awareness activities. | Behavioral: Control<br>* Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measured weight (nearest kg) | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist Circumference | Measured circumference (nearest cm) | Baseline to 24 months | 
| Lipids | Measured total cholesterol, triglycerides, HDL, LDL, ratio (mg/dL) | 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 |