The STRENGTH Study: Shapely Sisters Targeting Realistic Exercise and Nutrition Goals Through Healthy Habits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
This study evaluates the efficacy of a stress-focused tailored weight loss intervention compared to a standard weight loss intervention on weight loss in severely obese (BMI > 40.0) African American women.
详细描述
Stress has been identified as a major barrier to engaging in healthy lifestyle behaviors (e.g. diet and exercise) among African American women. African American women consistently lose less weight than their Caucasian counterparts in weight loss interventions. One reason for this disparity may be due to the failure of most weight loss interventions to address stress management adequately or in a culturally competent way.
The purpose of this study is to evaluate the efficacy of a stress-focused tailored weight loss intervention compared to a standard weight loss intervention on weight loss in severely obese (BMI > 40.0) African American women. The stress-focused weight loss intervention will incorporate stress management content throughout the entire intervention and will include content that is culturally tailored. The standard weight loss intervention will cover stress management techniques during one of the 14 sessions and the material will be more generic in nature (e.g. not culturally tailored).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •African American (self-identified)
- •BMI > 40 kg/m2
- •Access to internet connection and phone for personal use
排除标准
- •Unable to walk without the use of an assistance device
- •Failure to pass the Physical Activity Readiness Questionnaire (PAR-Q) or unable to attain medical clearance from their doctor
- •Substance abuse within past two years
- •Schizophrenia
- •Currently pregnant, pregnant within the past 6 months or plans to become pregnant in the next 6 months
- •History of malignancy other than non-melanoma skin cancer, that has not been in remission or cured surgically for > 5 years
- •Participation in a weight loss program in the past 12 months
- •> 5% loss of body weight within the past 6 months
- •Bariatric surgery recipient
- •Heart attack in the past 6 months
- •Stroke within the past 6 months
- •NOTE: Participants who "fail" the PAR-Q will be required to obtain medical clearance from their medical provider
结局指标
主要结局
Weight
时间窗: Change from Baseline to 6 Months
collect weight in pounds
次要结局
- Physical Activity(Change from Baseline to 6 Months)
- Psychosocial & Behavioral Measures(Change from Baseline to 6 Months)
- Walkability(Change from Baseline to 6 Months)
- Aerobic Fitness(Change from Baseline to 6 Months)
研究者
Danielle Braxton, MPH, RD
Graduate Research Assistant
University of North Carolina, Chapel Hill