Heart Health 4 New Moms: A Randomized Trial in the First Year After

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03749746
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Completed
Phase	N/A
Start date	January 26, 2019
Completion date	December 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04243317` - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults	N/A
Recruiting	`NCT04101669` - EndoBarrier System Pivotal Trial(Rev E v2)	N/A
Terminated	`NCT03772886` - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball	N/A
Completed	`NCT03640442` - Modified Ramped Position for Intubation of Obese Females.	N/A
Completed	`NCT04506996` - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2	N/A
Recruiting	`NCT06019832` - Analysis of Stem and Non-Stem Tibial Component	N/A
Active, not recruiting	`NCT05891834` - Study of INV-202 in Patients With Obesity and Metabolic Syndrome	Phase 2
Active, not recruiting	`NCT05275959` - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)	N/A
Recruiting	`NCT04575194` - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy	Phase 4
Completed	`NCT04513769` - Nutritious Eating With Soul at Rare Variety Cafe	N/A
Withdrawn	`NCT03042897` - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer	N/A
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Recruiting	`NCT05917873` - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation	N/A
Active, not recruiting	`NCT04353258` - Research Intervention to Support Healthy Eating and Exercise	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Recruiting	`NCT03227575` - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control	N/A
Completed	`NCT01870947` - Assisted Exercise in Obese Endometrial Cancer Patients	N/A
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting	`NCT05972564` - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function	Phase 1/Phase 2
Recruiting	`NCT05371496` - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia — HH4NM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms