NCT02077179

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

February 26, 2014

Last Update Submit

April 4, 2017

Conditions

Metabolic Cardiovascular Syndrome

Keywords

PostpartumPreeclampsiaGestational HypertensionGestational DiabetesExercise InterventionDietary InterventionBehavioral InterventionMobile WebsiteMobile Application

Outcome Measures

Primary Outcomes (1)

  • Metabolic Syndrome Z Score

    The primary outcome measure is the metabolic syndrome (MetS) z score, a continuous score of the five metabolic syndrome variables that make up the Adult Treatment Panel (ATP) III diagnostic criteria (waist circumference, blood pressure, high density lipoprotein, triglycerides and glucose). Differences between study arms will be compared.

    32 weeks postpartum

Secondary Outcomes (7)

  • Adherence to the HIP Program; Percent of Workouts Completed

    32 weeks postpartum

  • Differences in Biochemical Cardiovascular Risk Markers

    32 weeks postpartum

  • Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Midpoint

    20 weeks postpartum

  • Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Study Completion

    32 weeks postpartum

  • Change in Anthropomorphic Measurements and Blood Pressure from Midpoint to Study Completion

    32 weeks postpartum

  • +2 more secondary outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

Participants in this arm will receive care as per the usual standards from Kingston General Hospital and their primary care provider.

HIP Program

EXPERIMENTAL

Participants in this arm will follow the HIP Program in addition to their usual care from Kingston General Hospital and their primary care provider.

Behavioral: HIP Program

Interventions

HIP ProgramBEHAVIORAL

The entirety of the HIP Program is delivered through an interactive mobile website. The physical activity portion of the program consists of daily step counting, prescribed aerobic activity, structured strength and toning workouts, and daily stretching. The program was designed by a local trainer, specializing in postnatal exercise, to increase gradually in intensity, while encouraging a more active lifestyle. The program is designed to be completed at home with minimal equipment. The nutrition portion of the program consists of 16 video tutorials developed by a local Registered Dietitian and weekly diet logs. The video tutorials cover all aspects of healthy eating, from the basics of Canada's Food Guide, to smart snacking, to eating healthy over the holidays.

HIP Program

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's Unviersity

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (5)

  • 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.

    PMID: 24099450BACKGROUND

  • 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.

    PMID: 24316270BACKGROUND

  • 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.

    PMID: 22971452BACKGROUND

  • 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.

    PMID: 22971451BACKGROUND

  • 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.

    PMID: 18691690BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromePre-EclampsiaHypertension, Pregnancy-InducedDiabetes, Gestational

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Graeme N Smith, MD,PhD,FRCSC

    Queen's University

    PRINCIPAL INVESTIGATOR

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
Professor and Head of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 4, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)