Improving Weight Loss Outcomes of Black Women Using a Culturally-Relevant Stress-Management Enhanced Behavioral Weight Loss Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 341
- 试验地点
- 1
- 主要终点
- 4-month mean weight change of participants using SECA scale
研究概览
简要总结
The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI of at least 30 kg/m^2
- •elevated stress levels based on perceived stress scale score
- •self-identified as black race
排除标准
- •pregnant or are planning to become pregnant in the next year
- •known major medical or psychological condition known to influence body weight loss (e.g., medicated or poorly controlled diabetes (fasting blood glucose > 126 mg/dL), cardiovascular event in the preceding 12 months, history of gastric bypass surgery, bariatric surgery, or eating disorder)
- •history of psychiatric hospitalization in past 2 years
- •history of substance abuse or eating disorder
- •any condition for which a medical professional has suggested diet modification, physical activity, and/or weight reduction would be contraindicated.
- •currently taking medications for weight loss
研究组 & 干预措施
Weight Loss Plus Stress Management
Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training
干预措施: Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training (Behavioral)
Weight Loss Only
Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
干预措施: Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics (Behavioral)
结局指标
主要结局
4-month mean weight change of participants using SECA scale
时间窗: Baseline to Month 4
weight change as measured by a SECA scale in kilograms and baseline and month 4 will be calculated and averaged
12-month mean weight change of participants using SECA scale
时间窗: Baseline to Month 12
weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged
次要结局
- mean change in perceived stress using Perceived Stress Scale-10 score(Baseline to Month 12)