Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EMPOWER-Mom)

University of Pennsylvania

Status: Completed

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

Treatments: Behavioral: Virtual weigh-in; Behavioral: Online Behavioral Weight Loss Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04914819

5K23HL153667-03 (U.S. NIH Grant/Contract)

844694

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years;
2. Delivered a baby at HUP or PAH within 3-12 months prior to study start;
3. BMI ≥ 27 kg/m2
4. 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
5. Has online access through smartphone or computer and has email address
6. Ability to read and provide informed consent to participate in the study

Exclusion criteria

1. Delivered prior to 32 weeks gestation in the EMR

2. Documentation of fetal demise or neonatal demise in the EMR

3. Currently pregnant or planning to get pregnant within the next 5 months

4. Does not speak English

5. 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?

6. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Online Behavioral Weight Loss

Active Comparator group

Description:

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.

Treatment:

Behavioral: Online Behavioral Weight Loss Program

Behavioral: Virtual weigh-in

Usual Care

Active Comparator group

Description:

Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.

Treatment:

Behavioral: Virtual weigh-in