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Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia (HH4M)

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ClinicalTrials.gov Identifier: NCT02147626
Recruitment Status : Completed
First Posted : May 28, 2014
Results First Posted : February 15, 2021
Last Update Posted : February 15, 2021
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Preeclampsia Foundation
Information provided by (Responsible Party):
Janet Rich-Edwards, Brigham and Women's Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Preeclampsia Hypertension Post-partum Weight Retention Behavioral: Web-based educational and motivational modules Behavioral: Information and Screening Group Not Applicable

Detailed Description:
The study team will work with patients via focus groups to develop a novel internet-based program to provide information and tools for cardiovascular disease (CVD) risk reduction for women who are at increased risk of CVD by virtue of their history of preeclampsia, a common complication of pregnancy. The American Heart Association has recently issued guidelines that physicians should include history of the hypertensive pregnancy disorder, preeclampsia, as a risk factor for CVD. Indeed, research demonstrates that roughly 2 out of 3 women with a history of preeclampsia will die from CVD. This study will work with patients with prior preeclampsia and with the Preeclampsia Foundation, a patient- based organization, to create an online lifestyle modification program ( accessible by computer or smart phone) for women with recent preeclampsia to reduce CVD risk. The study is a randomized controlled trial to test the program's acceptability, use, and impact on diet, postpartum weight retention, physical activity, blood pressure, and patient knowledge and self-efficacy to improve health.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Heart Health 4 Moms: Engaging Women With a Recent History of Preeclampsia to Reduce Their Cardiovascular Disease Risk
Actual Study Start Date : September 21, 2015
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Information and Screening Group
Intervention: The patient website will include the American Heart Association (AHA) Class I Lifestyle recommendations (translated to an 8th grade reading level and with a link to the publication), a link to the online National Institutes of Health (NIH) Dietary Approaches to Stop Hypertension (DASH) website, and the NIH smoking cessation website
 Behavioral: Information and Screening Group
Experimental: HH4M Intervention Arm
Intervention: The HH4M patient website will include information and tools. These resources are customized to help new mothers achieve the AHA Class I Lifestyle recommendations for women with a history of preeclampsia.
 Behavioral: Web-based educational and motivational modules
Behavioral: Information and Screening Group


Outcome Measures
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Primary Outcome Measures :
  1. Eating Habits Confidence Survey [ Time Frame: 9 months after intervention starts ]
    The Eating Habits Confidence Survey measures the self-efficacy of a patient to improve their diet. Scores range from 1 (low self-efficacy) to 5 (high self-efficacy). A higher score is a better outcome.

  2. Exercise Confidence Survey [ Time Frame: 9 months after intervention starts ]
    The Exercise Confidence Survey measures self-efficacy of patient to increase physical activity Scores range from 1 (low self-efficacy) to 5 (high self-efficacy). A higher score is a better outcome.

  3. DASH Online Questionnaire [ Time Frame: 9 months after intervention starts ]
    The DASH Online Questionnaire is a food frequency questionnaire that prompts recall of daily servings of foods and beverages consumed in the past 30 days. We calculate a DASH score based on daily intake of eight components (fruits, vegetables, nuts and legumes, whole grains, low-fat dairy, sodium, lean meats and poultry, and sweets). Quintile rankings were summed across components to obtain a summary DASH score for each participant that ranged from 8 to 40. A higher score indicates higher DASH compliance.

  4. Pregnancy Physical Activity Questionnaire [ Time Frame: 9 months after intervention starts ]
    The Pregnancy Physical Activity Questionnaire is a validated questionnaire for women that includes activities relevant to caring for young children. Our measure ascertained type, duration, and frequency of recreational activity and childcare activity. It also measured inactivity (sedentary behavior), such as reading, using a computer, and watching television. The time spent in each activity is multiplied by its intensity measured in Metabolic Equivalent of Task Value (METS) to yield the average weekly energy expenditure related to that activity. The score ranged from 0 to 113 METS per week.

  5. Physical Inactivity in the Pregnancy Physical Activity Questionnaire [ Time Frame: 9 months after intervention starts ]
    The Pregnancy Physical Activity Questionnaire is a validated questionnaire for women that includes activities relevant to caring for young children. Our measure ascertained type, duration, and frequency of recreational activity and childcare activity. It also measured inactivity (sedentary behavior), such as reading, using a computer, and watching TV. The time spent in each inactivity was summed. The hours per week of reported inactivity ranged from 0 to 85.

  6. Patient Knowledge of Cardiovascular Disease Risk [ Time Frame: 9 months after intervention starts ]
    Adapted from 2012 American Heart Association National Survey of women's knowledge of their cardiovascular disease (CVD) risk; adaptation is knowledge of risk with respect to preeclampsia history. The score ranges from 1 (low knowledge) to 4 (high knowledge).

  7. Patient Control Over Cardiovascular Disease Risk [ Time Frame: 9 months after intervention starts ]
    To assess women's sense of personal control over their health, we adapted Kim and Walker's survey on perception of chronic diabetes risk among women with a history of gestational diabetes, using factor analysis (with varimax rotation) to reduce seven items from the Kim scales to a single factor we named ''Personal Control over Cardiovascular Disease Risk.'' The resulting measure had a Cronbach's alpha of 0.73. The score ranges from 1 (low control) to 4 (high control). High control is a better outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT02147626


Locations
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United States, Massachusetts
Brigham and Women's Hospital;
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
Patient-Centered Outcomes Research Institute
Preeclampsia Foundation
Investigators
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Principal Investigator: Janet Rich-Edwards, ScD Brigham and Women's Hospital
Principal Investigator: Ellen Seely, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Janet Rich-Edwards, Brigham and Women's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] January 5, 2017

More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Janet Rich-Edwards, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02147626    
Other Study ID Numbers: 2014P002765
CER-1306-02603 ( Other Grant/Funding Number: PCORI )
First Posted: May 28, 2014    Key Record Dates
Results First Posted: February 15, 2021
Last Update Posted: February 15, 2021
Last Verified: January 2021
Keywords provided by Janet Rich-Edwards, Brigham and Women's Hospital:
preeclampsia
cardiovascular disease
health behaviors
behavioral intervention
 web-based
Hypertension
Post-partum Weight Retention
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension
Cardiovascular Diseases
Gestational Weight Gain
Vascular Diseases
 Hypertension, Pregnancy-Induced
Pregnancy Complications
Weight Gain
Body Weight Changes
Body Weight