search
Back to results

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

Primary Purpose

Weight Loss, Postpartum Weight Retention, Hypertension in Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Behavioral Weight Loss Program
Virtual weigh-in
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring weight loss, postpartum period, hypertension in pregnancy, cardiovascular risk reduction, diabetes prevention program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Online Behavioral Weight Loss

Usual Care

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
Enrollment Rate Between Email Recruitment Strategies
We will compare enrollment rates between two behaviorally-framed email strategies
Sign-up Rate Between Mailer Recruitment Strategies
We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift
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.

Secondary Outcome Measures

Study Completion Rate Between 2 Arms
Proportion of participants that completed all follow-up procedures between both study arms.
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
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

Full Information

First Posted
May 20, 2021
Last Updated
June 15, 2023
Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04914819
Brief Title
Postpartum Weight Loss for Women at Elevated Cardiovascular Risk
Acronym
EMPOWER-Mom
Official Title
Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EmPOWER-Mom Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Postpartum Weight Retention, Hypertension in Pregnancy, Diabetes Mellitus in Pregnancy, Preeclampsia, Recruitment
Keywords
weight loss, postpartum period, hypertension in pregnancy, cardiovascular risk reduction, diabetes prevention program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Behavioral Weight Loss
Arm Type
Active Comparator
Arm 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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Online Behavioral Weight Loss Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual weigh-in
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Weight in Pounds From Baseline to 16-week Follow-up
Description
Mean change in weight in pounds from baseline to 16-week follow-up between study arms.
Time Frame
Baseline and 16 weeks
Title
Enrollment Rate Between Email Recruitment Strategies
Description
We will compare enrollment rates between two behaviorally-framed email strategies
Time Frame
8 weeks
Title
Sign-up Rate Between Mailer Recruitment Strategies
Description
We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift
Time Frame
8 weeks
Title
Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up
Description
Proportion of participants who lost 5 percent or more of their weight from baseline to 16-week follow-up between study groups.
Time Frame
Baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Study Completion Rate Between 2 Arms
Description
Proportion of participants that completed all follow-up procedures between both study arms.
Time Frame
16 weeks
Title
Intervention Arm: Number of Weeks With One or More Logins
Description
Engagement with BWL platform measured by mean number of weeks with one or more logins
Time Frame
16 weeks
Title
Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days
Description
Mean number of weeks that calories, physical activity minutes, and body weight were reported at least 5 of 7 days
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Postpartum Weight Loss for Women at Elevated Cardiovascular Risk

We'll reach out to this number within 24 hrs