Health Improvement After Pregnancy (HIP) Program Randomized Control Trial (HIP)
4. april 2017 opdateret af: Dr. Graeme Smith, Queen's University
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
43
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 2V7
- Queen's Unviersity
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Standard of Care
Participants in this arm will receive care as per the usual standards from Kingston General Hospital and their primary care provider.
|
|
|
Eksperimentel: 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.
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Metabolic Syndrome Z Score
Tidsramme: 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.
|
32 weeks postpartum
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence to the HIP Program; Percent of Workouts Completed
Tidsramme: 32 weeks postpartum
|
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.
|
32 weeks postpartum
|
|
Differences in Biochemical Cardiovascular Risk Markers
Tidsramme: 32 weeks postpartum
|
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.
|
32 weeks postpartum
|
|
Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Midpoint
Tidsramme: 20 weeks postpartum
|
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.
|
20 weeks postpartum
|
|
Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Study Completion
Tidsramme: 32 weeks postpartum
|
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.
|
32 weeks postpartum
|
|
Change in Anthropomorphic Measurements and Blood Pressure from Midpoint to Study Completion
Tidsramme: 32 weeks postpartum
|
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.
|
32 weeks postpartum
|
|
Adherence to the HIP Program; Percent of Step Counting Completed
Tidsramme: 32 weeks postpartum
|
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.
|
32 weeks postpartum
|
|
Adherence to the HIP Program; Percent of Dietary Logs Completed
Tidsramme: 32 weeks postpartum
|
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.
|
32 weeks postpartum
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Graeme N Smith, MD,PhD,FRCSC, Queen's University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2014
Primær færdiggørelse (Faktiske)
1. april 2016
Studieafslutning (Faktiske)
1. april 2016
Datoer for studieregistrering
Først indsendt
26. februar 2014
Først indsendt, der opfyldte QC-kriterier
3. marts 2014
Først opslået (Skøn)
4. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OBGY-249-14
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