Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02147626

Acronym

HH4M

Enrollment

151

Registered

2014-05-28

Start date

2015-09-21

Completion date

2017-05-31

Last updated

2021-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Hypertension, Post-partum Weight Retention, Preeclampsia

Keywords

preeclampsia, cardiovascular disease, health behaviors, behavioral intervention, web-based, Hypertension, Post-partum Weight Retention

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.

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.

Interventions

BEHAVIORALWeb-based educational and motivational modules

BEHAVIORALInformation and Screening Group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Eating Habits Confidence Survey	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	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	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	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	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	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	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.

Countries

United States

Participant flow

Recruitment details

From July 2015 to May 2016, women living in the United States with recent preeclampsia were recruited through the website and social media of the Preeclampsia Foundation, the March of Dimes Foundation, BabyCenter.com, and Craigslist.

Pre-assignment details

Women were eligible to participate if they had preeclampsia in the past five years and did not have current chronic hypertension; women also had to have access to the internet via computer or mobile device

Participants by arm

Arm	Count
Information and Screening Group Intervention: The patient website will include the 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) DASH website, and the NIH smoking cessation website Information and Screening Group	75
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. Web-based educational and motivational modules Information and Screening Group	76
Total	151

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	4	4
Overall Study	Pregnancy	1	2
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Information and Screening Group	Total	HH4M Intervention Arm
Adherence to Dietary Approaches to Stop Hypertension (DASH) Diet	23.1 units on a scale STANDARD_DEVIATION 4.8	24.3 units on a scale STANDARD_DEVIATION 5.1	24.4 units on a scale STANDARD_DEVIATION 4.9
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	75 Participants	151 Participants	76 Participants
Patient Control Over Cardiovascular Disease Risk	3.2 units on a scale STANDARD_DEVIATION 0.4	3.2 units on a scale STANDARD_DEVIATION 0.4	3.2 units on a scale STANDARD_DEVIATION 0.4
Patient Knowledge of Cardiovascular Disease Risk	2.0 units on a scale STANDARD_DEVIATION 0.9	2.0 units on a scale STANDARD_DEVIATION 0.8	1.9 units on a scale STANDARD_DEVIATION 0.8
Personal Health Self-efficacy (Eating)	4.3 units on a scale STANDARD_DEVIATION 0.6	4.4 units on a scale STANDARD_DEVIATION 0.6	4.4 units on a scale STANDARD_DEVIATION 0.6
Personal Health Self-efficacy (Physical Activity)	3.9 units on a scale STANDARD_DEVIATION 0.8	3.9 units on a scale STANDARD_DEVIATION 0.7	3.9 units on a scale STANDARD_DEVIATION 0.7
Physical Activity	26.3 METS/week STANDARD_DEVIATION 20.1	24.9 METS/week STANDARD_DEVIATION 18.5	23.5 METS/week STANDARD_DEVIATION 16.8
Physical inactivity	24.4 hours/week STANDARD_DEVIATION 14.9	23.5 hours/week STANDARD_DEVIATION 15.1	22.7 hours/week STANDARD_DEVIATION 15.3
Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latina	7 Participants	17 Participants	10 Participants
Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic African-American	2 Participants	4 Participants	2 Participants
Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Asian	1 Participants	3 Participants	2 Participants
Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Multi-race	2 Participants	3 Participants	1 Participants
Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White	63 Participants	124 Participants	61 Participants
Sex: Female, Male Female	75 Participants	151 Participants	76 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 70	0 / 69
other Total, other adverse events	0 / 70	0 / 69
serious Total, serious adverse events	0 / 70	0 / 69

Outcome results

Primary

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.