N/A N=151 Randomized Prevention

Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia

Cardiovascular Disease · Preeclampsia · Hypertension · Post-partum Weight Retention

Bottom Line

View on ClinicalTrials.gov: NCT02147626 ↗

Enrolled (actual)

151

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Eating Habits Confidence Survey — 4.2; 4.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Web-based educational and motivational modules (Behavioral); Information and Screening Group (Behavioral)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Brigham and Women's Hospital
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Eating Habits Confidence Survey	4.2; 4.5	—
PRIMARY Exercise Confidence Survey	3.7; 4	—
PRIMARY DASH Online Questionnaire	23.6; 24.5	—
PRIMARY Pregnancy Physical Activity Questionnaire	25.8; 26.6	—
PRIMARY Physical Inactivity in the Pregnancy Physical Activity Questionnaire	22.7; 16.5	—
PRIMARY Patient Knowledge of Cardiovascular Disease Risk	2.5; 2.7	—
PRIMARY Patient Control Over Cardiovascular Disease Risk	3.2; 3.2	—

Summary

This study will compare two arms in a randomized clinical trial of cardiovascular risk prevention in women with a history of preeclampsia. The first arm will provide postpartum patients and their clinicians with the American Heart Association's (AHA) Class I Lifestyle Recommendations for women with a history of preeclampsia. The second arm will additionally receive access to a customized patient-informed online program with modules on how to achieve the AHA recommendations for diet, activity and weight management.

Eligibility Criteria

Inclusion Criteria

Within 5 years of a live birth complicated by preeclampsia as determined by medical chart review
Age >=18
Not pregnant
Normotensive or prehypertensive
Access to the internet via computer or mobile device
Able to communicate in English or Spanish at an 8th grade level.

Exclusion Criteria

Type 1 or Type 2 diabetes
Currently pregnant
Diagnosis of hypertension BP >140/90 mm Hg or on medications for treatment of hypertension

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02147626). 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.