N/A
N=60
Postpartum Weight Loss for Women at Elevated Cardiovascular Risk
Weight Loss · Postpartum Weight Retention · Hypertension in Pregnancy · Diabetes Mellitus in Pregnancy · Preeclampsia
Bottom Line
View on ClinicalTrials.gov: NCT04914819 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Change in Weight in Pounds From Baseline to 16-week Follow-up — -8.6; -3.3 pounds — p=0.048
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Online Behavioral Weight Loss Program (Behavioral); Virtual weigh-in (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight in Pounds From Baseline to 16-week Follow-up |
-8.6; -3.3 | 0.048 sig |
| PRIMARY Enrollment Rate Between Email Recruitment Strategies |
88; 102 | 0.3 |
| PRIMARY Sign-up Rate Between Mailer Recruitment Strategies |
11; 16 | 0.331 |
| PRIMARY Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up |
9; 3 | 0.734 |
| SECONDARY Study Completion Rate Between 2 Arms |
26; 18; 4; 1; 3; 1 | — |
| SECONDARY Intervention Arm: Number of Weeks With One or More Logins |
8.6 | — |
| SECONDARY Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days |
5.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04914819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.