PRE-STARt Intervention - Trial of an Interactive Family Based Lifestyle Programme
2019年1月14日 更新者：University Hospitals, Leicester
Prevention Strategies for Adolescents at Risk of Diabetes - A Randomised Controlled Trial of an Interactive Family-based Lifestyle Programme
To investigate whether the interactive family based lifestyle programme leads to behaviour change at 6 months with the primary outcome being increased levels of moderate to vigorous physical activity (MVPA).
調査の概要
詳細な説明
To investigate whether the lifestyle programme results in changes to the following outcomes 3 and 6 months after baseline assessment (Child)
- An increase in objectively measured total amount of physical activity
- An increase in the proportion meeting MVPA guidelines (measured objectively)
- Reduction in time spent sedentary (measured objectively and self-reported)
- Change in self-reported physical activity
- Reduction in measures of adiposity (body mass index percentile, per cent body fat)
- Improvement in psychological factors that may mediate physical activity participation (self-efficacy, motivation, attitudes, social support and enjoyment of physical activity; and physical self-perceptions)
- Change in healthy food provision and parenting practices for healthy food
- Improvement in diet composition.
- Improvement in knowledge of physical activity and nutrition.
- Improvement in cardio-metabolic variables (blood pressure, glucose, HbA1c, cholesterol)
The Investigators will also include qualitative data collected from:
- Evaluation forms following each intervention workshop session which will be completed by the Parent/guardian, child and facilitator
- Feedback from focus groups to be held following completion of the total intervention i.e. 8 sessions
To investigate whether the lifestyle programme results in changes to the following outcomes 3 and 6 months after baseline assessment (Parent(s)/guardian(s))
- An increase in objectively measured total volume of physical activity
- An increase in the proportion meeting MVPA guidelines (measured objectively)
- Reduction in time spent sedentary (measured objectively and self-reported)
- Change in self-reported physical activity
- Reduction in measures of adiposity (body mass index percentile, per cent body fat)
- Change in healthy food provision and parenting practices for healthy food
- Improvement in diet composition.
- Improvement in knowledge of physical activity and nutrition.
研究の種類
介入
入学 (実際)
318
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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Leicester、イギリス、LE4 5pW
- University Hospitals of Leicester
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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
12年～14年 (子)
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
全て
説明
Inclusion Criteria:
Parents/guardians will answer questions in the eligibility questionnaire about their child and family health history. Participants will be invited to participate if they are 12-14 years old inclusive (12 years 0 days to 14 years 354 days old) and are identified as having the following risk factors for development of Type 2 Diabetes (which will be identified from the eligibility questionnaire):
BMI > 95th percentile for age and gender OR
BMI > 85th percentile PLUS one other from the following list:
- Family history of Diabetes (first degree relative).
- Non-white ethnicity.
- Watching TV/play computer games for more than 2 hours a day (self-report).
- Sugar intake more than 1.5 cans (or 532 ml) of fizzy pop/fruit juice per day (self-report).
Exclusion Criteria:
Young people will not be eligible for participation in the study if they are outside the age range of interest (<11 years and 364 days or >14 years and 1 day), have an existing diagnosis of Type 1 or Type 2 Diabetes, < 85th percentile. Young people will also be excluded if they themselves do not provide written assent or their parent/guardian does not provide written consent.
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：Control
The control participants will not receive the educational intervention but will be provided with a detailed advice leaflet for themselves and their parents/guardians.
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他の：Intervention
The educational intervention participants will receive the eight 90 minute sessions of an interactive family based lifestyle programme.
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Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).
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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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The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
時間枠：6 months post baseline
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Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
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6 months post baseline
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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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An increase in total volume of physical activity
時間枠：3 and 6 months
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Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
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3 and 6 months
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An increase in the proportion meeting MVPA guidelines
時間枠：3 and 6 months
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Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
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3 and 6 months
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Reduction in time spent sedentary
時間枠：3 and 6 months
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Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
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3 and 6 months
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Change in physical activity levels
時間枠：3 and 6 months
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Self reported - questionnaire
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3 and 6 months
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Reduction in Body mass index percentile (BMI)
時間枠：3 and 6 months
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Body mass will be measured to the nearest 0.1kg and height will be measured to the nearest 0.1 cm using a clinically approved bioelectrical impedance scale and a portable stadiometer, respectively.
BMI will be calculated as weight/height2 and will be converted to a BMI percentile based on WHO growth charts
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3 and 6 months
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Change in healthy food provision and parenting practices for healthy food
時間枠：3 and 6 months
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As parents are active participants in the intervention The Investigators will also query their knowledge and attitudes towards healthy eating and physical activity.
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3 and 6 months
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Improvement in diet composition
時間枠：3 and 6 months
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The Investigators will query the nutrition habits of participants to investigate any changes in the behaviours targeted in the workshops.
A food frequency questionnaire (FFQ) taken from the ISCOLE study that was adapted from the HBSC Study will be used to query the consumption of 23 food categories in a "usual" week.
The Investigators will also query breakfast consumption for weekdays and weekends.
The Investigators have also created ad hoc questions on other intervention targets of snacking behaviours, fruit and vegetable intake and fizzy drink consumption.
This ad hoc method has been used in other international multi-site studies.
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3 and 6 months
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Improvement in knowledge of physical activity and nutrition
時間枠：3 and 6 months
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The physical activity questionnaire for adolescents (PAQ-A) [62] will be used to assess the Types and context of physical activity in order to investigate changes in the Types of sports/exercise/activities the participating child may participate in (information which is not available from the accelerometer or the majority of other validated self-report questionnaires).
This questionnaire requests responses for the last 7 days by asking participants to check a list of activities for frequency of participation.
This questionnaire has received support from an expert panel and has also high validity against objective measures and moderate reliability.
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3 and 6 months
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Improvement in HbA1c
時間枠：3 and 6 months
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Biochemical measures (Child only) - HbA1c
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3 and 6 months
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Improvement in Triglycerides
時間枠：3 and 6 months
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Biochemical measures (Child only) - Triglycerides
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3 and 6 months
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Improvement in Glucose
時間枠：3 and 6 months
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Biochemical measures (Child only) - Glucose
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3 and 6 months
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Improvement in HDL-C
時間枠：3 and 6 months
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Biochemical measures (Child only) HDL-C
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3 and 6 months
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Improvement in Total Cholesterol
時間枠：3 and 6 months
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Biochemical measures (Child only) -Total cholesterol will be measured using a point-of-care testing (POCT) and LDL-C will be calculated.
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3 and 6 months
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Improvement in cardio-metabolic variables
時間枠：3 and 6 months
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Biochemical measures (Child only) - Capillary blood samples will be taken from each child using the finger prick method.
The CardioChek® system will be used as the POCT method.
The CardioChek® system is a portable hand held device that requires between 15 to 40 µL capillary sample from a finger-stick for each test.
The CardioChek® system is certified by the Cholesterol Reference Method Laboratory Network (CRMLN) and National Cholesterol Education Program (NCEP), is FDA-cleared, CE-marked, internationally registered, and is CLIA-waived by the Centers for Medicare & Medicaid Services, USA.
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3 and 6 months
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Blood Pressure (Child)
時間枠：3 and 6 months
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Arterial blood pressure will be measured using an automated sphygmomanometer with an appropriate sized cuff while the patient is seated, and having rested quietly for 5 minutes.
Three measurements will be obtained for blood pressure and an average of the last two will be used in any analysis.
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3 and 6 months
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Blood Pressure (Parent(s)/guardian(s))
時間枠：3 and 6 months
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Arterial blood pressure will be measured using an automated sphygmomanometer with an appropriate sized cuff while the patient is seated, and having rested quietly for 5 minutes.
Three measurements will be obtained for blood pressure and an average of the last two will be used in any analysis.
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3 and 6 months
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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。
協力者
捜査官
- 主任研究者：Melanie J Davies, MD、University Hospitals, Leicester
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
2016年7月1日
一次修了 (実際)
2017年3月1日
研究の完了 (実際)
2017年10月1日
試験登録日
最初に提出
2016年5月5日
QC基準を満たした最初の提出物
2016年7月22日
最初の投稿 (見積もり)
2016年7月27日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月16日
QC基準を満たした最後の更新が送信されました
2019年1月14日
最終確認日
2019年1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。