Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia

NCT02147626 | Completed Results DMC

• 2 other identifiers: 2014P002765CER-1306-02603
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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

  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

Study Arms (2)

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

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.

Behavioral: Web-based educational and motivational modules; Behavioral: Information and Screening Group

Interventions

Web-based educational and motivational modules BEHAVIORAL

HH4M Intervention Arm

Information and Screening Group BEHAVIORAL

HH4M Intervention Arm; Information and Screening Group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Preeclampsia Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital;

Boston, Massachusetts, 02120, United States

Location

Related Publications (6)

• 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.

  PMID: 3432232 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.

  PMID: 15595297 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.

  PMID: 14761901 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.

  PMID: 17575087 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.

  PMID: 19912673 BACKGROUND

• 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.

  PMID: 31215837 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Pre-Eclampsia; Hypertension; Health Behavior

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Behavior

Results Point of Contact

• Title: Dr. Janet Rich-Edwards
• Organization: Brigham and Women's Hospital

jr33@partners.org

6175258264

Study Officials

• Janet Rich-Edwards, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Ellen Seely, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 28, 2014
• Study Start: September 21, 2015
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: February 15, 2021
• Results First Posted: February 15, 2021

Record last verified: 2021-01

Locations

US (1)