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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT04914819
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.4
• Patients Per Site Per Month: 9.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Postpartum Weight Retention; Hypertension in Pregnancy; Diabetes Mellitus in Pregnancy; Preeclampsia; Recruitment	Behavioral: Online Behavioral Weight Loss Program; Behavioral: Virtual weigh-in	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EmPOWER-Mom Study)
• Actual Study Start Date: Jun 18, 2021
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: Online Behavioral Weight Loss Program; 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.; Behavioral: Virtual weigh-in; 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.
Active Comparator: Usual Care 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; 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.

Outcome Measures

Primary Outcome Measures

1. Change in weight in pounds from baseline to 16-week follow-up [16 weeks]

2. Enrollment rate between email recruitment strategies [8 weeks]

   We will compare enrollment rates between two behaviorally-framed email strategies

3. Enrollment rate between mailer recruitment strategies [8 weeks]

   We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift

4. Proportion of participants losing 5 percent or more of weight from baseline to 16-week follow-up [16 weeks]

Secondary Outcome Measures

1. Study completion rate between 2 arms [16 weeks]

2. Intervention arm: number of total logins [16 weeks]

   Engagement with BWL platform measured by total number of logins

3. Intervention arm: number of weeks with one or more logins [16 weeks]

   Engagement with BWL platform measured by number of weeks with one or more logins

4. Intervention arm: number of weeks with daily data reporting for at least 5 of 7 days [16 weeks]

   number of weeks that calories, physical activity minutes, and body weight were reported at least 5 of 7 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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?

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Lewey, MD, MPH, Assistant Professor of Medicine, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04914819
• Other Study ID Numbers: 844694
• First Posted: Jun 7, 2021
• Last Update Posted: Feb 8, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jennifer Lewey, MD, MPH, Assistant Professor of Medicine, University of Pennsylvania: weight loss; postpartum period; hypertension in pregnancy; cardiovascular risk reduction; diabetes prevention program
• Additional relevant MeSH terms: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy in Diabetics; Hypertension; Body Weight; Weight Loss; Gestational Weight Gain

Study Results

No Results Posted as of Feb 8, 2022