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| ID | Type | Description | Link |
|---|---|---|---|
| CER-1306-02603 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Preeclampsia Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based educational and motivational modules | Behavioral |
| ||
| Information and Screening Group |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 9 months after intervention starts |
| Physical Inactivity in the Pregnancy Physical Activity Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Rich-Edwards, ScD | Brigham and Women's Hospital | Principal Investigator |
| Ellen Seely, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital; | Boston | Massachusetts | 02120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3432232 | Background | 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. | |
| 15595297 | Background | 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. |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Women with a history of preeclampsia within the past five years were recruited via social media from the United States
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 9 months after intervention starts |
|
9 months after start of intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Janet Rich-Edwards | Brigham and Women's Hospital | 6175258264 | jr33@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2017 | Jul 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D011225 | Pre-Eclampsia |
| D006973 | Hypertension |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Behavioral |
|
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. |
| 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). | 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. | 9 months after intervention starts |
| 14761901 | Background | 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. |
| 17575087 | Background | 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. |
| 19912673 | Background | 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. |
| 31215837 | Result | 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. |
| Withdrawal by Subject |
|
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Personal Health Self-efficacy (Eating) | Mean | Standard Deviation | units on a scale |
|
| Personal Health Self-efficacy (Physical Activity) | Mean | Standard Deviation | units on a scale |
|
| Physical Activity | Mean | Standard Deviation | METS/week |
|
| Physical inactivity | Mean | Standard Deviation | hours/week |
|
| Adherence to Dietary Approaches to Stop Hypertension (DASH) Diet | Mean | Standard Deviation | units on a scale |
|
| Patient Knowledge of Cardiovascular Disease Risk | Mean | Standard Deviation | units on a scale |
|
| Patient Control Over Cardiovascular Disease Risk | Mean | Standard Deviation | units on a scale |
|
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
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 9 months after intervention starts |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 9 months after intervention starts |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | METs/week | 9 months after intervention starts |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Hours/week | 9 months after intervention starts |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | 9 months after intervention starts |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 9 months after intervention starts |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | 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 | 0 | 69 | 0 | 69 | 0 | 69 |
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| D014652 | Vascular Diseases |
| D001519 | Behavior |