Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EmPOWER-Mom Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Enrollment Rate Between Email Recruitment Strategies
研究概览
简要总结
The aim of this study is to test the feasibility and effectiveness of a 16-week online behavioral weight loss program compared to usual care to promote weight loss in the postpartum period among women with cardiovascular risk factors. The investigators will also be testing different behavioral strategies to recruit postpartum women to the study, including 2 email recruitment strategies and 2 mailer recruitment strategies, informed by behavioral design.
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
- 否
入选标准
- •Age ≥18 years;
- •Delivered a baby at HUP or PAH within 3-12 months prior to study start;
- •BMI ≥ 27 kg/m2
- •Diagnosis of one of the following medical conditions: chronic hypertension, gestational hypertension, preeclampsia, eclampsia, gestational diabetes, or diabetes mellitus (type 1 or 2) based on diagnosis codes in the EMR
- •Has online access through smartphone or computer and has email address
- •Ability to read and provide informed consent to participate in the study
排除标准
- •Delivered prior to 32 weeks gestation in the EMR
- •Documentation of fetal demise or neonatal demise in the EMR
- •Currently pregnant or planning to get pregnant within the next 5 months
- •Does not speak English
- •Answers yes to any of the following questions:
- •Are you currently participating in any other weight loss or physical activity studies?
- •Do you have any medical conditions or other reasons why you could not participate in a 16-week weight loss or physical activity program?
- •Participants will be excluded after completing the run-in period if they do not complete the daily food log or their baseline BMI is < 27 kg/m2
结局指标
主要结局
Enrollment Rate Between Email Recruitment Strategies
时间窗: 8 weeks
We will compare enrollment rates between two behaviorally-framed email strategies
Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up
时间窗: Baseline and 16 weeks
Proportion of participants who lost 5 percent or more of their weight from baseline to 16-week follow-up between study groups.
Change in Weight in Pounds From Baseline to 16-week Follow-up
时间窗: Baseline and 16 weeks
Mean change in weight in pounds from baseline to 16-week follow-up between study arms.
Sign-up Rate Between Mailer Recruitment Strategies
时间窗: 8 weeks
We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift
次要结局
- Intervention Arm: Number of Weeks With One or More Logins(16 weeks)
- Study Completion Rate Between 2 Arms(16 weeks)
- Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days(16 weeks)
研究者
Jennifer Lewey, MD, MPH
Assistant Professor of Medicine
University of Pennsylvania