Postpartum Weight Loss for Women at Elevated Cardiovascular Risk

Not Applicable

Completed

• Conditions: Preeclampsia; Hypertension in Pregnancy; Recruitment; Weight Loss; Postpartum Weight Retention; Diabetes Mellitus in Pregnancy
• Interventions: Behavioral: Virtual weigh-in; Behavioral: Online Behavioral Weight Loss Program

• Registration Number: NCT04914819
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-07
• Study Start: 2021-06-18
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Results First Submitted: 2023-02-06
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Results First Posted: 2023-07-06
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Virtual weigh-in	Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided.
Online Behavioral Weight Loss	Virtual weigh-in	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.
Online Behavioral Weight Loss	Online Behavioral Weight Loss Program	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.

Primary Outcome Measures

Name	Time	Method
Enrollment Rate Between Email Recruitment Strategies	8 weeks	We will compare enrollment rates between two behaviorally-framed email strategies
Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up	Baseline and 16 weeks	Proportion of participants who lost 5 percent or more of their weight from baseline to 16-week follow-up between study groups.
Change in Weight in Pounds From Baseline to 16-week Follow-up	Baseline and 16 weeks	Mean change in weight in pounds from baseline to 16-week follow-up between study arms.
Sign-up Rate Between Mailer Recruitment Strategies	8 weeks	We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift

Secondary Outcome Measures

Name	Time	Method
Intervention Arm: Number of Weeks With One or More Logins	16 weeks	Engagement with BWL platform measured by mean number of weeks with one or more logins
Study Completion Rate Between 2 Arms	16 weeks	Proportion of participants that completed all follow-up procedures between both study arms.
Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days	16 weeks	Mean number of weeks that calories, physical activity minutes, and body weight were reported at least 5 of 7 days

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States