Metabolic Cardiovascular SyndromeHIPNCT02077179

Health Improvement After Pregnancy (HIP) Program Randomized Control Trial

A study testing HIP Program in people with Metabolic Cardiovascular Syndrome, run by Queen's University at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Any age, women only
Conditions the study is for: Metabolic Cardiovascular Syndrome
What is being tested?: HIP Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteCanada
Study dates: Sep 2014to Apr 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Queen's Unviersity
Kingston, Ontario, K7L 2V7

Other trials in Canada

About this study

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.

Conditions: Metabolic Cardiovascular Syndrome
Being tested: HIP Program
Keywords: Postpartum, Preeclampsia, Gestational Hypertension, Gestational Diabetes, Exercise Intervention, Dietary Intervention, Behavioral Intervention, Mobile Website, Mobile Application
Medical subject headings: Metabolic Syndrome, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HIP ProgramBehavioural
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.

Study groups in NCT02077179
Study group	Role	What they receive
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. Receives: Behavioral: HIP Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 32 weeks postpartum

Secondary outcomes (7)

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.
Measured: 32 weeks postpartum
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.
Measured: 32 weeks postpartum
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.
Measured: 20 weeks postpartum
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.
Measured: 32 weeks postpartum
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.
Measured: 32 weeks postpartum
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.
Measured: 32 weeks postpartum
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.
Measured: 32 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Apr 2016

First posted4 Mar 2014 (estimated)
Study startSep 2014
Primary completionApr 2016
Study completionApr 2016

Why it stopped: Poor retention and recruitment,changes need to be made to the program

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Metabolic Cardiovascular SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02077179
Sponsor's protocol ID: OBGY-249-14
Acronym: HIP
Status last verified: Apr 2017
First submitted: 26 Feb 2014
Last updated: 5 Apr 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 24099450
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.
PubMed 24316270
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.
PubMed 22971452
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.
PubMed 22971451
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.
PubMed 18691690

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Cardiovascular Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health Improvement After Pregnancy (HIP) Program Randomized Control Trial
ClinicalTrials.gov ID: NCT02077179
Acronym / sponsor ID: HIP / OBGY-249-14
Conditions: Metabolic Cardiovascular Syndrome
Keywords: Postpartum, Preeclampsia, Gestational Hypertension, Gestational Diabetes, Exercise Intervention, Dietary Intervention, Behavioral Intervention, Mobile Website
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor retention and recruitment,changes need to be made to the program
Enrolment: 43 participants (actual)
Lead sponsor: Queen's UniversityUniversity, hospital or other
Study start: Sep 2014
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 4 Mar 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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	Behavioral: HIP ProgramParticipants in this arm will follow the HIP Program in addition to their usual care from Kingston General Hospital and their primary care provider.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HIP ProgramThe 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.	Behavioural	HIP Program

Primary outcome

Metabolic Syndrome Z Score
Time frame: 32 weeks postpartum
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.

7 secondary outcomes

Adherence to the HIP Program; Percent of Workouts Completed
Time frame: 32 weeks postpartum
Differences in Biochemical Cardiovascular Risk Markers
Time frame: 32 weeks postpartum
Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Midpoint
Time frame: 20 weeks postpartum
Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Study Completion
Time frame: 32 weeks postpartum
Change in Anthropomorphic Measurements and Blood Pressure from Midpoint to Study Completion
Time frame: 32 weeks postpartum
Adherence to the HIP Program; Percent of Step Counting Completed
Time frame: 32 weeks postpartum
Adherence to the HIP Program; Percent of Dietary Logs Completed
Time frame: 32 weeks postpartum

Results and safety

The study was stopped early (reason given: Poor retention and recruitment,changes need to be made to the program). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Background: PubMed 24099450Smith 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.
Background: PubMed 24316270Cusimano 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.
Background: PubMed 22971452Smith 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.
Background: PubMed 22971451Smith 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.
Background: PubMed 18691690Smith 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.
Individual participant dataSharing planned: No

Related trials for Metabolic Cardiovascular Syndrome

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Graeme N Smith, MD,PhD,FRCSC principal investigator

Queen's University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HIP Program in people with Metabolic Cardiovascular Syndrome, run by Queen's University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Poor retention and recruitment,changes need to be made to the program). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic Syndrome Z Score (time frame: 32 weeks postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02077179, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.