Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EmPOWER-Mom Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Enrollment Rate Between Email Recruitment Strategies
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Online Behavioral Weight Loss
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Intervention: Online Behavioral Weight Loss Program (Behavioral)
Online Behavioral Weight Loss
Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study.
Intervention: Virtual weigh-in (Behavioral)
Usual Care
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Intervention: Virtual weigh-in (Behavioral)
Outcomes
Primary Outcomes
Enrollment Rate Between Email Recruitment Strategies
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 8 weeks
We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift
Secondary Outcomes
- 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)
Investigators
Jennifer Lewey, MD, MPH
Assistant Professor of Medicine
University of Pennsylvania