Reducing Obesity in Underserved Postpartum African American Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 主要终点
- Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
研究概览
简要总结
In this proposal, the investigators will develop a culturally-tailored, 8-week clinic-based weight loss program to reduce obesity among postpartum African American (AA) adult women that can be integrated into a postpartum care model within a clinical setting.
详细描述
The investigators proposal adapts The Diabetes Prevention Program (DPP) 16 session core curriculum to our 8 session model and in addition uses the cultural tailoring techniques of the DPP to address the needs of our AA population in several ways: 1) The reference materials and lesson handouts include information about the types of foods and cooking methods used by an AA culture (see Other Study Documents); 2) Topics are selected for group classes that are most appropriate for our participants such as Hip Hop or Salsa dancing for physical activity.
Participants will be randomized during the early postpartum period to either usual care or intervention. Usual care participants will be offered the weight management standard of care which is one visit with a dietitian in the Nutrition and Weight Management Center. Intervention participants will be assigned a Birth Sister for the postpartum period. They will also attend 8 weekly sessions for the weight loss program. All participants will complete study assessment visits at 6 weeks postpartum and 15 weeks postpartum.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pre-Natal:
- •BMI greater than or equal to 25
- •Ready to change (classified as answering yes to: Are you seriously considering trying to lose weight to reach your goal in the next 6 months?)
- •English-speaking
- •Post-partum:
- •Live birth (based on medical record review)
排除标准
- •Pre-Natal:
- •Signs of moderate to severe depression based on the Patient Health Questionnaire-9 (PHQ-9)
- •Previous enrollment in the Birth Sister's program prior to the study
- •Post-partum:
- •Signs of moderate to severe post-partum depression based on the Edinburgh Postnatal Depression Scale (EPDS)
研究组 & 干预措施
Intervention
Weekly, in-person, support groups providing nutrition and physical activity education
干预措施: Nutrition and physical activity education (Behavioral)
Control
Standard of care - one counseling visit with a study dietitian
结局指标
主要结局
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
时间窗: Weekly up to 8 weeks
次要结局
- Waist Circumference at 8 Weeks(8 weeks)
- Change From Baseline Weight to 8 Weeks(Baseline and 8 weeks)
- Participant Satisfaction as Measured by Questionnaire and Exit Interview(8 weeks)
- Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire(Baseline and 8 weeks)
- Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire(Baseline and 8 weeks)
- Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale(Baseline and 8 weeks)
研究者
Caroline Apovian
Professor of Medicine and Pediatrics
Boston Medical Center