Health Improvement After Pregnancy (HIP) Program Randomized Control Trial

NCT ID: NCT02077179

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Cardiovascular Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

HIP Program

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

Group Type EXPERIMENTAL

HIP Program

Intervention Type BEHAVIORAL

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.

Interventions

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HIP Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Graeme Smith

Professor and Head of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Graeme N Smith, MD,PhD,FRCSC

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Queen's Unviersity

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 24099450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24316270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22971452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22971451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18691690 (View on PubMed)

Other Identifiers

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OBGY-249-14

Identifier Type: -

Identifier Source: org_study_id

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