Deep South Network for Cancer Control - Healthier Weight Among African American Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •African American female
- •Live or work in target county
- •BMI >= 25 kg/m2
排除标准
- •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
结局指标
主要结局
Weight
时间窗: baseline to 6-months
Measured weight (nearest kg)
次要结局
- Lipids(baseline to 6-months)
- Social Support Healthy Eating and Exercise(baseline to 24-months)
- Self Efficacy for Healthy Eating and Exercise(baseline to 24-months)
- Weight(baseline to 24-months)
- Perceived Stress Scale(baseline to 24-months)
- Waist Circumference(baseline to 6-months)
- Blood Pressure(baseline to 6-months)
- Social Support for Healthy Eating and Exercise(baseline to 12-months)
- Dietary Intake(baseline to 24-months)
研究者
Monica L Baskin
Principal Investigator
University of Alabama at Birmingham