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

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

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 Overview

• Status: Completed
• Conditions: Weight Loss; Recruitment; Preeclampsia; Hypertension in Pregnancy; Diabetes Mellitus in Pregnancy; Postpartum Weight Retention
• Intervention / Treatment: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Virtual weigh-in

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: weight loss; postpartum period; hypertension in pregnancy; cardiovascular risk reduction; diabetes prevention program
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Body Weight Changes; Weight Gain; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Weight Loss; Body Weight; Pre-Eclampsia; Pregnancy in Diabetics; Hypertension, Pregnancy-Induced; Gestational Weight Gain
• Other Study ID Numbers: 844694; 5K23HL153667-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No