Clinical trial NCT04914819: Postpartum Weight Loss for Women at Elevated Cardiovascular Risk
Official title: Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EmPOWER-Mom Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-06-07
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Weight in Pounds From Baseline to 16-week Follow-up
timeFrame: Baseline and 16 weeks
measure: Enrollment Rate Between Email Recruitment Strategies
timeFrame: 8 weeks
measure: Sign-up Rate Between Mailer Recruitment Strategies
timeFrame: 8 weeks
measure: Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Study Completion Rate Between 2 Arms
timeFrame: 16 weeks
measure: Intervention Arm: Number of Weeks With One or More Logins
timeFrame: 16 weeks
measure: Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: