Clinical trial NCT02077179: Health Improvement After Pregnancy (HIP) Program Randomized Control Trial
Official title: Health Improvement After Pregnancy (HIP) Program Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metabolic Cardiovascular Syndrome
Keywords: Postpartum
Preeclampsia
Gestational Hypertension
Gestational Diabetes
Exercise Intervention
Dietary Intervention
Behavioral Intervention
Mobile Website
Mobile Application
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 43
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Recent Canadian studies, public opinion polls and the Canadian Heart Health Strategy and Action Plan state that women's heart health is a key national priority; it should be addressed through improving heart health awareness and prevention, and reducing care inequities for women in general and younger women in particular. The investigators have developed an innovative and interactive mobile website based postpartum lifestyle modification program (regular physical activity and nutritional guidance), based on established national guidelines, to improve heart disease risk factors in women. The investigators will conduct a trial to determine if the mobile website based lifestyle modification program can be maintained and reduces a collection of risk factors, which occurring together, greatly increases the risk of developing heart disease. The investigators hypothesize that the interactive mobile website directing regular physical activity and personalized nutritional guidance, compared to standard postpartum care, will be motivational and result in a reduced modified metabolic syndrome z score at 8 months postpartum among the intervention group.


Eligibility criteria: Inclusion Criteria:

- must own or have daily access to one or more of the following; smart phone, tablet or laptop computer

Exclusion Criteria:

* Living greater than 100km from Kingston General Hospital
* Having an existing and long term contraindication to exercise at the time of recruitment

Primary outcomes:
measure: Metabolic Syndrome Z Score
timeFrame: 32 weeks postpartum
Secondary outcomes:
measure: Adherence to the HIP Program; Percent of Workouts Completed
timeFrame: 32 weeks postpartum
measure: Differences in Biochemical Cardiovascular Risk Markers
timeFrame: 32 weeks postpartum
measure: Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Midpoint
timeFrame: 20 weeks postpartum
measure: Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Study Completion
timeFrame: 32 weeks postpartum
measure: Change in Anthropomorphic Measurements and Blood Pressure from Midpoint to Study Completion
timeFrame: 32 weeks postpartum
measure: Adherence to the HIP Program; Percent of Step Counting Completed
timeFrame: 32 weeks postpartum
measure: Adherence to the HIP Program; Percent of Dietary Logs Completed
timeFrame: 32 weeks postpartum
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's Unviersity
state: Ontario
Study officials:
affiliation: Queen's University
name: Graeme N Smith, MD,PhD,FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith GN, Pudwell J, Roddy M. The Maternal Health Clinic: a new window of opportunity for early heart disease risk screening and intervention for women with pregnancy complications. J Obstet Gynaecol Can. 2013 Sep;35(9):831-839. doi: 10.1016/S1701-2163(15)30841-0. No abstract available.
citation: Cusimano MC, Pudwell J, Roddy M, Cho CK, Smith GN. The maternal health clinic: an initiative for cardiovascular risk identification in women with pregnancy-related complications. Am J Obstet Gynecol. 2014 May;210(5):438.e1-9. doi: 10.1016/j.ajog.2013.12.001. Epub 2013 Dec 4.
citation: Smith GN, Pudwell J, Walker M, Wen SW. Risk estimation of metabolic syndrome at one and three years after a pregnancy complicated by preeclampsia. J Obstet Gynaecol Can. 2012 Sep;34(9):836-841. doi: 10.1016/S1701-2163(16)35382-8.
citation: Smith GN, Pudwell J, Walker M, Wen SW. Ten-year, thirty-year, and lifetime cardiovascular disease risk estimates following a pregnancy complicated by preeclampsia. J Obstet Gynaecol Can. 2012 Sep;34(9):830-835. doi: 10.1016/S1701-2163(16)35381-6.
citation: Smith GN, Walker MC, Liu A, Wen SW, Swansburg M, Ramshaw H, White RR, Roddy M, Hladunewich M; Pre-Eclampsia New Emerging Team (PE-NET). A history of preeclampsia identifies women who have underlying cardiovascular risk factors. Am J Obstet Gynecol. 2009 Jan;200(1):58.e1-8. doi: 10.1016/j.ajog.2008.06.035. Epub 2008 Aug 8.