Women of Color and Family Obesity Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 454
- 主要终点
- Weight (lb)
研究概览
简要总结
The proposed randomized controlled trial will evaluate an educational self-management intervention in 450 African American women and weight management. It will be the first to use a culturally tailored in-person and telephone approach to address all aspects of wellness and social determinants for African American women to achieve optimal long term wellness for both self and family.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self-identified African American woman, aged 20-59
- •BMI 27.5-57.4
- •Ability to walk unrestricted for > 3 min
- •Caretaker of a child -providing a meal at least 50% of days/week
- •Caretaker of at least one child aged 5 -12 years
- •Resides in Jackson, Saginaw, Ypsilanti, Lansing, Detroit (All cities in Michigan)
- •Speaks English fluently
排除标准
- •<12 months postpartum
- •Active pregnancy
- •Prior or anticipated bariatric surgery
- •Non-ambulatory
- •History of a severe cardiovascular event (including cerebrovascular accident or myocardial infarction)
- •Severe mental illness, neurologic disease and/or cognitive impairment
研究组 & 干预措施
Intervention
Subjects will be randomized to the program intervention which is a female-specific, culturally relevant, self-regulation based in-person group sessions and telephone counseling intervention designed for African American women who are overweight or obese.
干预措施: PRIDE counseling intervention (Behavioral)
Control
Usual care
结局指标
主要结局
Weight (lb)
时间窗: Closing Event (Month 12)
After 12 months all women will be invited to come to a clinical data collection event "Closing Event" where weight will be collected for all women on the same measurement scale. All measurements will be taken by project staff to ensure data validly.
次要结局
- Height (inches)(Closing Event (Month 12))
- Waist Circumference (inches)(Closing Event (Month 12))
- Blood Pressure (mmHg)(Closing Event (Month 12))
- Total Cholesterol (mg/dL)(Closing Event (Month 12))
- High Density Lipoprotein Cholesterol (mg/dL)(Closing Event (Month 12))
- Low Density Lipoprotein Cholesterol (mg/dL)(Closing Event (Month 12))
- Triglycerides (mg/dL)(Closing Event (Month 12))
- Hemoglobin A1c(Closing Event (Month 12))
- Total Distance Walked (ft)(Closing Event (Month 12))
研究者
Randall Brown
PI
University of Michigan