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

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ClinicalTrials.gov Identifier: NCT03749746
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Alisse Hauspurg, University of Pittsburgh

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 Not Applicable

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. 90 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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 : January 26, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Weight loss [ Time Frame: 4-8 weeks postpartum to 8-12 months postpartum ]
    weight change between two study visits


Secondary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: 8-12 months postpartum ]
    Systolic blood pressure at study visit 2

  2. Diastolic blood pressure [ Time Frame: 8-12 months postpartum ]
    Diastolic blood pressure at study visit 2

  3. Hypertension [ Time Frame: 8-12 months postpartum ]
    Proportion of women with hypertension by AHA guidelines



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pre-pregnancy body mass index ≥25 kg/m2
  • diagnosed with preeclampsia
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749746


Contacts
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Contact: Nidha Khan, MPH 412-641-3295 khann4@mwri.magee.edu
Contact: Alisse Hauspurg, MD 412-641-2291 janickia@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Magee-Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Nidha Khan, MPH    412-641-3295    khann4@mwri.magee.edu   
Contact: Alisse Hauspurg, MD    412-641-2291    janickia@upmc.edu   
Principal Investigator: Alisse Hauspurg, MD         
Sub-Investigator: Janet Catov, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Alisse Hauspurg, MD Magee-Womens Hospital of University of Pittsburgh Medical Center
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Responsible Party: Alisse Hauspurg, Fellow, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03749746    
Other Study ID Numbers: 18080007
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Toxemia
Pre-Eclampsia
Pregnancy Complications
Hypertension, Pregnancy-Induced
Hypertension
Obesity
Overweight
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Infection