Cardiovascular DiseaseHH4MNCT02147626

Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia

A study testing Web-based educational and motivational modules and Information and Screening Group in people with Cardiovascular Disease and Preeclampsia, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 44 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cardiovascular Disease, Preeclampsia, Hypertension
What is being tested?: Web-based educational and motivational modules and Information and Screening Group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 151 participants
Where: 1 siteUnited States
Study dates: 21 Sep 2015to 31 May 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 44 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital;
Boston, Massachusetts, 02120

Other trials in United States

About this study

Official title: Heart Health 4 Moms: Engaging Women With a Recent History of Preeclampsia to Reduce Their Cardiovascular Disease Risk

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.

Read the 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.

Conditions: Cardiovascular Disease, Preeclampsia, Hypertension, Post-partum Weight Retention
Being tested: Web-based educational and motivational modules, Information and Screening Group
Keywords: preeclampsia, cardiovascular disease, health behaviors, behavioral intervention, web-based, Hypertension, Post-partum Weight Retention
Medical subject headings: Cardiovascular Diseases, Pre-Eclampsia, Hypertension, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Web-based educational and motivational modulesBehavioural
Information and Screening GroupBehavioural

Study groups in NCT02147626
Study group	Role	What they receive
Information and Screening Group	Active comparator	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 Receives: Behavioral: Information and Screening Group
HH4M Intervention Arm	Experimental	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. Receives: Behavioral: Web-based educational and motivational modules; Behavioral: Information and Screening Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Eating Habits Confidence Survey
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.
Measured: 9 months after intervention starts
Exercise Confidence Survey
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.
Measured: 9 months after intervention starts
DASH Online Questionnaire
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.
Measured: 9 months after intervention starts
Pregnancy Physical Activity Questionnaire
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.
Measured: 9 months after intervention starts
Physical Inactivity in the Pregnancy Physical Activity Questionnaire
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.
Measured: 9 months after intervention starts
Patient Knowledge of Cardiovascular Disease Risk
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).
Measured: 9 months after intervention starts
Patient Control Over Cardiovascular Disease Risk
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.
Measured: 9 months after intervention starts

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 201531 May 2017

First posted28 May 2014 (estimated)
Study start21 Sep 2015
Primary completion31 May 2017
Study completion31 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02147626
Sponsor's protocol ID: 2014P002765
Other IDs: CER-1306-02603
Acronym: HH4M
Status last verified: Jan 2021
First submitted: 20 May 2014
Last updated: 15 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
PubMed 3432232
Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sports Exerc. 2004 Oct;36(10):1750-60. doi: 10.1249/01.mss.0000142303.49306.0d.
PubMed 15595297
Mosca L, Ferris A, Fabunmi R, Robertson RM; American Heart Association. Tracking women's awareness of heart disease: an American Heart Association national study. Circulation. 2004 Feb 10;109(5):573-9. doi: 10.1161/01.CIR.0000115222.69428.C9. Epub 2004 Feb 4.
PubMed 14761901
Kim C, McEwen LN, Piette JD, Goewey J, Ferrara A, Walker EA. Risk perception for diabetes among women with histories of gestational diabetes mellitus. Diabetes Care. 2007 Sep;30(9):2281-6. doi: 10.2337/dc07-0618. Epub 2007 Jun 15.
PubMed 17575087
Apovian CM, Murphy MC, Cullum-Dugan D, Lin PH, Gilbert KM, Coffman G, Jenkins M, Bakun P, Tucker KL, Moore TJ. Validation of a web-based dietary questionnaire designed for the DASH (dietary approaches to stop hypertension) diet: the DASH online questionnaire. Public Health Nutr. 2010 May;13(5):615-22. doi: 10.1017/S1368980009991996. Epub 2009 Nov 16.
PubMed 19912673
Rich-Edwards JW, Stuart JJ, Skurnik G, Roche AT, Tsigas E, Fitzmaurice GM, Wilkins-Haug LE, Levkoff SE, Seely EW. Randomized Trial to Reduce Cardiovascular Risk in Women with Recent Preeclampsia. J Womens Health (Larchmt). 2019 Nov;28(11):1493-1504. doi: 10.1089/jwh.2018.7523. Epub 2019 Jun 19.
PubMed 31215837

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Heart Health 4 Moms: Engaging Women With a Recent History of Preeclampsia to Reduce Their Cardiovascular Disease Risk
ClinicalTrials.gov ID: NCT02147626
Acronym / sponsor ID: HH4M / 2014P002765
Conditions: Cardiovascular Disease, Preeclampsia, Hypertension, Post-partum Weight Retention
Keywords: preeclampsia, cardiovascular disease, health behaviors, behavioral intervention, web-based, Hypertension, Post-partum Weight Retention
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute, Preeclampsia Foundation
Study start: 21 Sep 2015 (actual)
Primary completion: 31 May 2017 (actual)
Study completion: 31 May 2017 (actual)
First posted: 28 May 2014 (estimated)
Results: Posted 15 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Information and Screening Group	Active comparator	Behavioral: Information and Screening GroupIntervention: 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
HH4M Intervention Arm	Experimental	Behavioral: Web-based educational and motivational modules, Behavioral: Information and Screening GroupIntervention: 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.

Who may qualify

Ages: 18 to 44 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Web-based educational and motivational modules	Behavioural	HH4M Intervention Arm
Information and Screening Group	Behavioural	HH4M Intervention Arm, Information and Screening Group

Primary outcome

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.
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.
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.
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.
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.
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).
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.

Results and safety

Results posted to the registry on 15 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Information and Screening Group	75	70
HH4M Intervention Arm	76	69

Primary outcome: Eating Habits Confidence Survey

Time frame: 9 months after intervention starts. Mean (Standard Deviation). Unit: units on a scale

Measure	Information and Screening Group n = 70	HH4M Intervention Arm n = 69
Value	4.2 (0.7)	4.5 (0.6)

Primary outcome: Exercise Confidence Survey

Time frame: 9 months after intervention starts. Mean (Standard Deviation). Unit: units on a scale

Measure	Information and Screening Group n = 70	HH4M Intervention Arm n = 69
Value	3.7 (1)	4 (0.7)

Primary outcome: DASH Online Questionnaire

Time frame: 9 months after intervention starts. Mean (Standard Deviation). Unit: units on a scale

Measure	Information and Screening Group n = 70	HH4M Intervention Arm n = 69
Value	23.6 (4.8)	24.5 (4.7)

Primary outcome: Pregnancy Physical Activity Questionnaire

Time frame: 9 months after intervention starts. Mean (Standard Deviation). Unit: METs/week

Measure	Information and Screening Group n = 70	HH4M Intervention Arm n = 69
Value	25.8 (18.2)	26.6 (19.5)

Adverse events

Time frame: 9 months after start of intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Information and Screening Group	0 of 70 (0%)	0 of 70 (0%)	0 of 70
HH4M Intervention Arm	0 of 69 (0%)	0 of 69 (0%)	0 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 3432232Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
Background: PubMed 15595297Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sports Exerc. 2004 Oct;36(10):1750-60. doi: 10.1249/01.mss.0000142303.49306.0d.
Background: PubMed 14761901Mosca L, Ferris A, Fabunmi R, Robertson RM; American Heart Association. Tracking women's awareness of heart disease: an American Heart Association national study. Circulation. 2004 Feb 10;109(5):573-9. doi: 10.1161/01.CIR.0000115222.69428.C9. Epub 2004 Feb 4.
Background: PubMed 17575087Kim C, McEwen LN, Piette JD, Goewey J, Ferrara A, Walker EA. Risk perception for diabetes among women with histories of gestational diabetes mellitus. Diabetes Care. 2007 Sep;30(9):2281-6. doi: 10.2337/dc07-0618. Epub 2007 Jun 15.
Background: PubMed 19912673Apovian CM, Murphy MC, Cullum-Dugan D, Lin PH, Gilbert KM, Coffman G, Jenkins M, Bakun P, Tucker KL, Moore TJ. Validation of a web-based dietary questionnaire designed for the DASH (dietary approaches to stop hypertension) diet: the DASH online questionnaire. Public Health Nutr. 2010 May;13(5):615-22. doi: 10.1017/S1368980009991996. Epub 2009 Nov 16.
Results publication: PubMed 31215837Rich-Edwards JW, Stuart JJ, Skurnik G, Roche AT, Tsigas E, Fitzmaurice GM, Wilkins-Haug LE, Levkoff SE, Seely EW. Randomized Trial to Reduce Cardiovascular Risk in Women with Recent Preeclampsia. J Womens Health (Larchmt). 2019 Nov;28(11):1493-1504. doi: 10.1089/jwh.2018.7523. Epub 2019 Jun 19.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janet Rich-Edwards, ScD principal investigator

Brigham and Women's Hospital

Ellen Seely, MD principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eating Habits Confidence Survey (time frame: 9 months after intervention starts). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02147626, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.