Health Improvement After Pregnancy (HIP) Program Randomized Control Trial (HIP)
2017年4月4日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
43
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Ontario
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Kingston、Ontario、カナダ、K7L 2V7
- Queen's Unviersity
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Standard of Care
Participants in this arm will receive care as per the usual standards from Kingston General Hospital and their primary care provider.
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実験的：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.
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Metabolic Syndrome Z Score
時間枠：32 weeks postpartum
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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.
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32 weeks postpartum
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adherence to the HIP Program; Percent of Workouts Completed
時間枠：32 weeks postpartum
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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.
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32 weeks postpartum
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Differences in Biochemical Cardiovascular Risk Markers
時間枠：32 weeks postpartum
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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.
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32 weeks postpartum
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Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Midpoint
時間枠：20 weeks postpartum
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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.
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20 weeks postpartum
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Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Study Completion
時間枠：32 weeks postpartum
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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.
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32 weeks postpartum
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Change in Anthropomorphic Measurements and Blood Pressure from Midpoint to Study Completion
時間枠：32 weeks postpartum
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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.
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32 weeks postpartum
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Adherence to the HIP Program; Percent of Step Counting Completed
時間枠：32 weeks postpartum
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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.
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32 weeks postpartum
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Adherence to the HIP Program; Percent of Dietary Logs Completed
時間枠：32 weeks postpartum
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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.
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32 weeks postpartum
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Graeme N Smith, MD,PhD,FRCSC、Queen's University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年9月1日
一次修了 (実際)
2016年4月1日
研究の完了 (実際)
2016年4月1日
試験登録日
最初に提出
2014年2月26日
QC基準を満たした最初の提出物
2014年3月3日
最初の投稿 (見積もり)
2014年3月4日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月5日
QC基準を満たした最後の更新が送信されました
2017年4月4日
最終確認日
2017年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。