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

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT03749746

Collaborator

(none)

148

Enrollment

Location

Arms

34.2

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia Gestational Hypertension Hypertension Obesity Overweight and Obesity Pregnancy Complications Pregnancy Toxemia Postpartum Preeclampsia	Behavioral: Home Blood Pressure Monitoring Behavioral: Heart Health 4 New Moms Other: Usual care	N/A

Detailed 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

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official 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

Actual Study Start Date :

Jan 26, 2019

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Usual care 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.	Other: Usual care 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.
Experimental: Home Blood Pressure Monitoring In addition to usual care outlined above, each participant will receive a Bluetooth-enabled blood pressure cuff along with a checklist of proper technique and instructions on use. Women will be prompted to measure their BP across the first week of each month during the intervention. Based on guidelines, participants will take their blood pressure in the morning and evening, each time taking two readings separated by one minute.	Behavioral: Home Blood Pressure Monitoring 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.
Experimental: Heart Health 4 New Moms Participants randomized to this group will receive instruction on the use of Heart Health 4 New Moms internet-based lifestyle intervention and home blood pressure monitoring. The internet-based intervention is comprised of four key components: an online curriculum with modules on healthy eating and physical activity, a self-monitoring and tracking program, a registered dietitian will act as a lifestyle coach for participants and a customized online toolbox.	Behavioral: Home Blood Pressure Monitoring 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. Behavioral: Heart Health 4 New Moms 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).

Arm

Intervention/Treatment

Active Comparator: Usual care

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.

Other: Usual care

Experimental: Home Blood Pressure Monitoring

In addition to usual care outlined above, each participant will receive a Bluetooth-enabled blood pressure cuff along with a checklist of proper technique and instructions on use. Women will be prompted to measure their BP across the first week of each month during the intervention. Based on guidelines, participants will take their blood pressure in the morning and evening, each time taking two readings separated by one minute.

Behavioral: Home Blood Pressure Monitoring

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.

Experimental: Heart Health 4 New Moms

Participants randomized to this group will receive instruction on the use of Heart Health 4 New Moms internet-based lifestyle intervention and home blood pressure monitoring. The internet-based intervention is comprised of four key components: an online curriculum with modules on healthy eating and physical activity, a self-monitoring and tracking program, a registered dietitian will act as a lifestyle coach for participants and a customized online toolbox.

Behavioral: Home Blood Pressure Monitoring

Behavioral: Heart Health 4 New Moms

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).

Outcome Measures

Primary Outcome Measures

Weight loss [4-8 weeks postpartum to 8-12 months postpartum]
weight change between two study visits

Secondary Outcome Measures

Systolic blood pressure [8-12 months postpartum]
Systolic blood pressure at study visit 2
Diastolic blood pressure [8-12 months postpartum]
Diastolic blood pressure at study visit 2
Hypertension [8-12 months postpartum]
Proportion of women with hypertension by AHA guidelines

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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