PRE-STARt Intervention - Trial of an Interactive Family Based Lifestyle Programme
2019년 1월 14일 업데이트: 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).
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (실제)
등록
318
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Leicester, 영국, LE4 5pW
- University Hospitals of Leicester
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
12년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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간섭 없음: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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.
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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An increase in total volume of physical activity
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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))
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Melanie J Davies, MD, University Hospitals, Leicester
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
연구 시작
2016년 7월 1일
기본 완료 (실제)
기본 완료
2017년 3월 1일
연구 완료 (실제)
연구 완료
2017년 10월 1일
연구 등록 날짜
최초 제출
최초 제출
2016년 5월 5일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2016년 7월 22일
처음 게시됨 (추정)
처음 게시됨
2016년 7월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2019년 1월 16일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2019년 1월 14일
마지막으로 확인됨
마지막으로 확인됨
2019년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 65436
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Non identifiable participant data will be only be shared with the study collaborators.
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .