Postpartum Weight Loss for Women at Elevated Cardiovascular Risk

Weight Loss Clinical Trial

— EMPOWER-Mom  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914819
• Other study ID #: 844694
• Secondary ID: 5K23HL153667-03
• Status: Completed
• Phase: N/A
• Start date: June 18, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus in Pregnancy
• Gestational Weight Gain
• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Postpartum Weight Retention
• Pre-Eclampsia
• Preeclampsia
• Pregnancy in Diabetics
• Recruitment
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Enrollment Rate Between Email Recruitment Strategies	We will compare enrollment rates between two behaviorally-framed email strategies	8 weeks
Primary	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
Primary	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	Study Completion Rate Between 2 Arms	Proportion of participants that completed all follow-up procedures between both study arms.	16 weeks
Secondary	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
Secondary	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