Journey to Better Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Deep South Network for Cancer Control - Healthier Weight Among African American Women

Conditions
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Weight Loss

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American female Live or work 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) Cardiovascular event in the preceding 12 months History of gastric bypass 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: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 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) | Behavioral: Weight Loss Only<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>|
| Experimental: Weight Loss Plus<br>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 | Behavioral: Weight Loss Plus<br>* 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.<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 6-months | 
| Blood Pressure | Measured blood pressure (mmHG) - systolic and diastolic | 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 |