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Health Improvement After Pregnancy (HIP) Program Randomized Control Trial (HIP)

Primary Purpose

Metabolic Cardiovascular Syndrome

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HIP Program
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Cardiovascular Syndrome focused on measuring Postpartum, Preeclampsia, Gestational Hypertension, Gestational Diabetes, Exercise Intervention, Dietary Intervention, Behavioral Intervention, Mobile Website, Mobile Application

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Queen's Unviersity

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

HIP Program

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adherence to the HIP Program; Percent of Workouts Completed
Adherence to the HIP Program will be assessed based on the number of times a participant indicates using the mobile website that a prescribed workout has been completed. This outcome will only be measured in the intervention arm.
Differences in Biochemical Cardiovascular Risk Markers
Differences between study arms for the following biochemical cardiovascular risk markers will be assessed at 32 weeks postpartum; lipid profile, fasting glucose, glycated hemoglobin, high sensitivity C-reactive protein, and urine microalbumin creatinine ratio.
Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Midpoint
Changes in systolic blood pressure, diastolic blood pressure and weight from baseline measures at 6-8 weeks postpartum will be assessed at the midpoint of the program at 20 weeks postpartum. Differences between study arms will be compared.
Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Study Completion
Changes in systolic blood pressure, diastolic blood pressure and weight from baseline measures at 6-8 weeks postpartum will be assessed at the midpoint of the program at 32 weeks postpartum. Differences between study arms will be compared.
Change in Anthropomorphic Measurements and Blood Pressure from Midpoint to Study Completion
Changes in systolic blood pressure, diastolic blood pressure, weight, body mass index, hip circumference, and waist circumference from midpoint measures at 20 weeks postpartum will be assessed at the end of the program at 32 weeks postpartum. Differences between study arms will be compared.
Adherence to the HIP Program; Percent of Step Counting Completed
Adherence to the HIP Program will be assessed based on the number of times a participant uses the mobile website to log their daily step count total. The number of times that the logged step count meets or exceeds the prescribed number of daily steps will also be assessed. This outcome will only be measured in the intervention arm.
Adherence to the HIP Program; Percent of Dietary Logs Completed
Adherence to the HIP Program will be assessed based on the number of times a participant uses the mobile website to enter the weekly dietary log. The number of times that the dietary log meets the prescribed intake for each of the Canada's Food Guide food groups will also be assessed. This outcome will only be measured in the intervention arm.

Full Information

First Posted
February 26, 2014
Last Updated
April 4, 2017
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT02077179
Brief Title
Health Improvement After Pregnancy (HIP) Program Randomized Control Trial
Acronym
HIP
Official Title
Health Improvement After Pregnancy (HIP) Program Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor retention and recruitment,changes need to be made to the program
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Cardiovascular Syndrome
Keywords
Postpartum, Preeclampsia, Gestational Hypertension, Gestational Diabetes, Exercise Intervention, Dietary Intervention, Behavioral Intervention, Mobile Website, Mobile Application

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants in this arm will receive care as per the usual standards from Kingston General Hospital and their primary care provider.
Arm Title
HIP Program
Arm Type
Experimental
Arm Description
Participants in this arm will follow the HIP Program in addition to their usual care from Kingston General Hospital and their primary care provider.
Intervention Type
Behavioral
Intervention Name(s)
HIP Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Metabolic Syndrome Z Score
Description
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.
Time Frame
32 weeks postpartum
Secondary Outcome Measure Information:
Title
Adherence to the HIP Program; Percent of Workouts Completed
Description
Adherence to the HIP Program will be assessed based on the number of times a participant indicates using the mobile website that a prescribed workout has been completed. This outcome will only be measured in the intervention arm.
Time Frame
32 weeks postpartum
Title
Differences in Biochemical Cardiovascular Risk Markers
Description
Differences between study arms for the following biochemical cardiovascular risk markers will be assessed at 32 weeks postpartum; lipid profile, fasting glucose, glycated hemoglobin, high sensitivity C-reactive protein, and urine microalbumin creatinine ratio.
Time Frame
32 weeks postpartum
Title
Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Midpoint
Description
Changes in systolic blood pressure, diastolic blood pressure and weight from baseline measures at 6-8 weeks postpartum will be assessed at the midpoint of the program at 20 weeks postpartum. Differences between study arms will be compared.
Time Frame
20 weeks postpartum
Title
Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Study Completion
Description
Changes in systolic blood pressure, diastolic blood pressure and weight from baseline measures at 6-8 weeks postpartum will be assessed at the midpoint of the program at 32 weeks postpartum. Differences between study arms will be compared.
Time Frame
32 weeks postpartum
Title
Change in Anthropomorphic Measurements and Blood Pressure from Midpoint to Study Completion
Description
Changes in systolic blood pressure, diastolic blood pressure, weight, body mass index, hip circumference, and waist circumference from midpoint measures at 20 weeks postpartum will be assessed at the end of the program at 32 weeks postpartum. Differences between study arms will be compared.
Time Frame
32 weeks postpartum
Title
Adherence to the HIP Program; Percent of Step Counting Completed
Description
Adherence to the HIP Program will be assessed based on the number of times a participant uses the mobile website to log their daily step count total. The number of times that the logged step count meets or exceeds the prescribed number of daily steps will also be assessed. This outcome will only be measured in the intervention arm.
Time Frame
32 weeks postpartum
Title
Adherence to the HIP Program; Percent of Dietary Logs Completed
Description
Adherence to the HIP Program will be assessed based on the number of times a participant uses the mobile website to enter the weekly dietary log. The number of times that the dietary log meets the prescribed intake for each of the Canada's Food Guide food groups will also be assessed. This outcome will only be measured in the intervention arm.
Time Frame
32 weeks postpartum

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graeme N Smith, MD,PhD,FRCSC
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's Unviersity
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24099450
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.
Results Reference
background
PubMed Identifier
24316270
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.
Results Reference
background
PubMed Identifier
22971452
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.
Results Reference
background
PubMed Identifier
22971451
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.
Results Reference
background
PubMed Identifier
18691690
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.
Results Reference
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Health Improvement After Pregnancy (HIP) Program Randomized Control Trial

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