Status:
COMPLETED
Postpartum Weight Loss for Women at Elevated Cardiovascular Risk
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Weight Loss
Postpartum Weight Retention
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04914819
Start Date
June 18 2021
End Date
December 31 2021
Last Update
July 6 2023
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104