Obesity Clinical Trial
— HH4NMOfficial title:
Heart Health 4 New Moms: A Randomized Controlled Trial of a Lifestyle Intervention and Home Blood Pressure Monitoring Following Preeclampsia in Overweight and Obese Women
Verified date | December 2021 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Preeclampsia causes devastating maternal and neonatal morbidity and mortality with a high recurrence risk and a rapid, occult progression to cardiovascular disease after delivery. There is a critical need for effective interventions to reduce these risks. This is a pilot randomized controlled trial of a novel postpartum lifestyle intervention compared to women who take home blood pressure measurements and women with usual care who are overweight and obese in the first year after preeclampsia. The investigators hypothesize that the intervention will lead to improved weight loss and blood pressure in the first year postpartum, which has broad implications for future pregnancy and long-term cardiovascular health.
Status | Completed |
Enrollment | 148 |
Est. completion date | December 1, 2021 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - pre-pregnancy body mass index =25 kg/m2 - diagnosed with preeclampsia or gestational hypertension - access to internet Exclusion Criteria: - multiple gestation - medical co-morbidities: chronic kidney disease, active liver disease (acute hepatitis, chronic active hepatitis), active cardiac disease, pre-pregnancy diabetes mellitus, chronic hypertension diagnosed prior to pregnancy - pregnancy prior to randomization |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Magee-Womens Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight loss | weight change between two study visits | 4-8 weeks postpartum to 8-12 months postpartum | |
Secondary | Systolic blood pressure | Systolic blood pressure at study visit 2 | 8-12 months postpartum | |
Secondary | Diastolic blood pressure | Diastolic blood pressure at study visit 2 | 8-12 months postpartum | |
Secondary | Hypertension | Proportion of women with hypertension by AHA guidelines | 8-12 months postpartum |
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