University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
NCT Number: NCT02938312
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.
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Notify Me30 year–70 year
Female
Interventional
Not applicable
Birmingham, Alabama, 35294, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: baseline to 6-months
Measured weight (nearest kg)
Time frame: baseline to 6-months
Measured circumference (nearest cm)
Time frame: baseline to 6-months
Measured blood pressure (mmHG) - systolic and diastolic
Time frame: baseline to 6-months
Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio
Time frame: baseline to 12-months
Measured weight (nearest kg)
Time frame: baseline to 24-months
Measured weight (nearest kg)
Time frame: 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.
Time frame: baseline to 12-months
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated.
Time frame: 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.
Time frame: baseline to 6-months
Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated.
Time frame: baseline to 12-months
Self-report
Time frame: baseline to 24-months
Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated.
Time frame: baseline to 6-months
24 hour recall
Time frame: baseline to 12-months
24 hour recall
Time frame: baseline to 24-months
24 hour recall
Time frame: baseline to 6-months
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Time frame: baseline to 12-months
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Time frame: baseline to 24-months
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
University of Alabama at Birmingham
Other
Deep South Network for Cancer Control - Healthier Weight Among African American Women
Acronym: JTBH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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