Weight Loss
Conditions
Brief summary
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
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).
Interventions
BEHAVIORALWeight Loss Only
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.
BEHAVIORALWeight Loss Plus
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.
Sponsors
National Cancer Institute (NCI)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | baseline to 6-months | Measured weight (nearest kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | baseline to 6-months | Measured blood pressure (mmHG) - systolic and diastolic |
| Lipids | baseline to 6-months | Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio |
| Weight | baseline to 12-months | Measured weight (nearest kg) |
| Social Support for Healthy Eating and Exercise | baseline to 6-months | Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated. |
| Waist Circumference | baseline to 6-months | Measured circumference (nearest cm) |
| Self Efficacy for Healthy Eating and Exercise | baseline to 6-months | Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated. |
| Dietary Intake | baseline to 6-months | 24 hour recall |
| Perceived Stress Scale | baseline to 6-months | Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses. |
| Social Support Healthy Eating and Exercise | baseline to 24-months | Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated. |
Countries
United States
Outcome results
None listed