Trial Outcomes & Findings for Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia (NCT NCT02147626)
NCT ID: NCT02147626
Last Updated: 2021-02-15
Results Overview
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.
COMPLETED
NA
151 participants
9 months after intervention starts
2021-02-15
Participant Flow
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.
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
Participant milestones
| Measure |
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
Information and Screening Group
|
HH4M Intervention Arm
Intervention: The HH4M patient website will include information and tools. These resources are customized to help new mothers achieve the American Heart Association ( AHA) Class I Lifestyle recommendations for women with a history of preeclampsia.
Web-based educational and motivational modules
Information and Screening Group
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
76
|
|
Overall Study
COMPLETED
|
70
|
69
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
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
Information and Screening Group
|
HH4M Intervention Arm
Intervention: The HH4M patient website will include information and tools. These resources are customized to help new mothers achieve the American Heart Association ( AHA) Class I Lifestyle recommendations for women with a history of preeclampsia.
Web-based educational and motivational modules
Information and Screening Group
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Pregnancy
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia
Baseline characteristics by cohort
| Measure |
Information and Screening Group
n=75 Participants
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
|
HH4M Intervention Arm
n=76 Participants
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
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
|
63 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic African-American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Multi-race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latina
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Personal Health Self-efficacy (Eating)
|
4.3 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Personal Health Self-efficacy (Physical Activity)
|
3.9 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Physical Activity
|
26.3 METS/week
STANDARD_DEVIATION 20.1 • n=5 Participants
|
23.5 METS/week
STANDARD_DEVIATION 16.8 • n=7 Participants
|
24.9 METS/week
STANDARD_DEVIATION 18.5 • n=5 Participants
|
|
Physical inactivity
|
24.4 hours/week
STANDARD_DEVIATION 14.9 • n=5 Participants
|
22.7 hours/week
STANDARD_DEVIATION 15.3 • n=7 Participants
|
23.5 hours/week
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Adherence to Dietary Approaches to Stop Hypertension (DASH) Diet
|
23.1 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
24.4 units on a scale
STANDARD_DEVIATION 4.9 • n=7 Participants
|
24.3 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Patient Knowledge of Cardiovascular Disease Risk
|
2.0 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Patient Control Over Cardiovascular Disease Risk
|
3.2 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 9 months after intervention startsThe 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.
Outcome measures
| Measure |
Information and Screening Group
n=70 Participants
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
|
HH4M Intervention Arm
n=69 Participants
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
|
|---|---|---|
|
Eating Habits Confidence Survey
|
4.2 units on a scale
Standard Deviation 0.7
|
4.5 units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: 9 months after intervention startsThe 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.
Outcome measures
| Measure |
Information and Screening Group
n=70 Participants
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
|
HH4M Intervention Arm
n=69 Participants
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
|
|---|---|---|
|
Exercise Confidence Survey
|
3.7 units on a scale
Standard Deviation 1
|
4 units on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: 9 months after intervention startsThe 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.
Outcome measures
| Measure |
Information and Screening Group
n=70 Participants
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
|
HH4M Intervention Arm
n=69 Participants
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
|
|---|---|---|
|
DASH Online Questionnaire
|
23.6 units on a scale
Standard Deviation 4.8
|
24.5 units on a scale
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: 9 months after intervention startsThe 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.
Outcome measures
| Measure |
Information and Screening Group
n=70 Participants
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
|
HH4M Intervention Arm
n=69 Participants
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
|
|---|---|---|
|
Pregnancy Physical Activity Questionnaire
|
25.8 METs/week
Standard Deviation 18.2
|
26.6 METs/week
Standard Deviation 19.5
|
PRIMARY outcome
Timeframe: 9 months after intervention startsThe 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.
Outcome measures
| Measure |
Information and Screening Group
n=70 Participants
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
|
HH4M Intervention Arm
n=69 Participants
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
|
|---|---|---|
|
Physical Inactivity in the Pregnancy Physical Activity Questionnaire
|
22.7 Hours/week
Standard Deviation 16.5
|
16.5 Hours/week
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: 9 months after intervention startsAdapted 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).
Outcome measures
| Measure |
Information and Screening Group
n=70 Participants
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
|
HH4M Intervention Arm
n=69 Participants
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
|
|---|---|---|
|
Patient Knowledge of Cardiovascular Disease Risk
|
2.5 units on a scale
Standard Deviation 0.9
|
2.7 units on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 9 months after intervention startsTo 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.
Outcome measures
| Measure |
Information and Screening Group
n=70 Participants
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
|
HH4M Intervention Arm
n=69 Participants
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
|
|---|---|---|
|
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
|
Adverse Events
Information and Screening Group
HH4M Intervention Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place