Postpartum Weight Loss for Women at Elevated Cardiovascular Risk

Study Overview
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Brief Summary
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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.

Official Title
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Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EmPOWER-Mom Study)

Conditions
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Weight Loss, Postpartum Weight Retention, Hypertension in Pregnancy, Diabetes Mellitus in Pregnancy, Preeclampsia, Recruitment

Intervention / Treatment
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* Behavioral: Online Behavioral Weight Loss Program
* Behavioral: Virtual weigh-in


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Online Behavioral Weight Loss<br>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. | Behavioral: Online Behavioral Weight Loss Program<br>* Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.<br>Behavioral: Virtual weigh-in<br>* Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.<br>|
| Active Comparator: Usual Care<br>Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided. | Behavioral: Virtual weigh-in<br>* Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight in Pounds From Baseline to 16-week Follow-up | Mean change in weight in pounds from baseline to 16-week follow-up between study arms. | Baseline and 16 weeks | 
| Enrollment Rate Between Email Recruitment Strategies | We will compare enrollment rates between two behaviorally-framed email strategies | 8 weeks | 
| Sign-up Rate Between Mailer Recruitment Strategies | We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift | 8 weeks | 
| Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up | Proportion of participants who lost 5 percent or more of their weight from baseline to 16-week follow-up between study groups. | Baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Completion Rate Between 2 Arms | Proportion of participants that completed all follow-up procedures between both study arms. | 16 weeks | 
| Intervention Arm: Number of Weeks With One or More Logins | Engagement with BWL platform measured by mean number of weeks with one or more logins | 16 weeks | 
| Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days | Mean number of weeks that calories, physical activity minutes, and body weight were reported at least 5 of 7 days | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, postpartum period, hypertension in pregnancy, cardiovascular risk reduction, diabetes prevention program