University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT03749746
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
The overall objective of this study is to conduct a pilot trial of an internet-based lifestyle intervention and home blood pressure monitoring in the year after delivery among overweight and obese women with preeclampsia to evaluate feasibility, acceptability and to assess the effect of the intervention. The investigators hypothesize that compared to usual care, an internet-based lifestyle intervention implemented in the immediate postpartum period in overweight and obese women with preeclampsia improves weight loss at one year postpartum. 150 overweight or obese women with preeclampsia will be randomized into internet-based lifestyle intervention plus home blood pressure monitoring, home blood pressure monitoring alone, or usual care groups in the postpartum period. The investigators will assess feasibility by the proportions of women who are eligible, enroll, and remain in the study at one year. The effect of home blood pressure monitoring on blood pressure and progression to sustained hypertension will also be explored. A successful outcome of this study would have a direct impact to improve cardiovascular health and future pregnancy health in women who have had preeclampsia.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each participant will receive 1:1 training by the project staff in all aspects of home blood pressure monitoring (HBPM). Throughout the study, they will be asked to monitor home blood pressures for the first week of each month with Bluetooth-enabled blood pressure cuffs.
The intervention is comprised of four key components: (1) The online curriculum consists of 12 modules on healthy eating and physical activity adapted from the Diabetes Prevention Program and specifically targeting postpartum women. (2) Self-monitoring and tracking program, in which participants will be provided with a Bluetooth-enabled blood pressure cuff and digital scale and will be provided real-time feedback on their blood pressure and weight trends. (3) A registered dietitian will act as a lifestyle coach for participants with regular review of progress and provision of coaching notes, support and suggestions. (4) Finally participants will have access to a customized online toolbox, including dietary tracking sheets and recipes from the American Heart Association (AHA).
Participants will be counseled on routine postpartum care and will receive additional information on cardiovascular risk following preeclampsia as well as information on support groups and registries as well as online resources for lifestyle modification.
Time frame: 4-8 weeks postpartum to 8-12 months postpartum
weight change between two study visits
Time frame: 8-12 months postpartum
Systolic blood pressure at study visit 2
Time frame: 8-12 months postpartum
Diastolic blood pressure at study visit 2
Time frame: 8-12 months postpartum
Proportion of women with hypertension by AHA guidelines
University of Pittsburgh
Other
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
Acronym: HH4NM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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