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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

Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE November 21, 2018
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE January 26, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
Weight loss [ Time Frame: 4-8 weeks postpartum to 8-12 months postpartum ]
weight change between two study visits
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • Systolic blood pressure [ Time Frame: 8-12 months postpartum ]
    Systolic blood pressure at study visit 2
  • Diastolic blood pressure [ Time Frame: 8-12 months postpartum ]
    Diastolic blood pressure at study visit 2
  • Hypertension [ Time Frame: 8-12 months postpartum ]
    Proportion of women with hypertension by AHA guidelines
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • Blood pressure [ Time Frame: 8-12 months postpartum ]
    Blood pressure at study visit 2
  • Hypertension [ Time Frame: 8-12 months postpartum ]
    Proportion of women with hypertension by AHA guidelines
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Preeclampsia
  • Gestational Hypertension
  • Hypertension
  • Obesity
  • Overweight and Obesity
  • Pregnancy Complications
  • Pregnancy Toxemia
  • Postpartum Preeclampsia
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Home Blood Pressure Monitoring
  • 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.
    Interventions:
    • Behavioral: Home Blood Pressure Monitoring
    • Behavioral: Heart Health 4 New Moms
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nidha Khan, MPH 412-641-3295 khann4@mwri.magee.edu
Contact: Alisse Hauspurg, MD 412-641-2291 janickia@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03749746
Other Study ID Numbers  ICMJE 18080007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alisse Hauspurg, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alisse Hauspurg, MD Magee-Womens Hospital of University of Pittsburgh Medical Center
PRS Account University of Pittsburgh
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP