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PRE-STARt Intervention - Trial of an Interactive Family Based Lifestyle Programme

14 января 2019 г. обновлено: 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).

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

318

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 12 лет до 14 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Без вмешательства: 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.
Другой: Intervention
The educational intervention participants will receive the eight 90 minute sessions of an interactive family based lifestyle programme.
Поведенческий: Interactive Lifestyle programme workshop
Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
Временное ограничение: 6 months post baseline
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
6 months post baseline

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
An increase in total volume of physical activity
Временное ограничение: 3 and 6 months
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
3 and 6 months
An increase in the proportion meeting MVPA guidelines
Временное ограничение: 3 and 6 months
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
3 and 6 months
Reduction in time spent sedentary
Временное ограничение: 3 and 6 months
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
3 and 6 months
Change in physical activity levels
Временное ограничение: 3 and 6 months
Self reported - questionnaire
3 and 6 months
Reduction in Body mass index percentile (BMI)
Временное ограничение: 3 and 6 months
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
3 and 6 months
Change in healthy food provision and parenting practices for healthy food
Временное ограничение: 3 and 6 months
As parents are active participants in the intervention The Investigators will also query their knowledge and attitudes towards healthy eating and physical activity.
3 and 6 months
Improvement in diet composition
Временное ограничение: 3 and 6 months
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.
3 and 6 months
Improvement in knowledge of physical activity and nutrition
Временное ограничение: 3 and 6 months
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.
3 and 6 months
Improvement in HbA1c
Временное ограничение: 3 and 6 months
Biochemical measures (Child only) - HbA1c
3 and 6 months
Improvement in Triglycerides
Временное ограничение: 3 and 6 months
Biochemical measures (Child only) - Triglycerides
3 and 6 months
Improvement in Glucose
Временное ограничение: 3 and 6 months
Biochemical measures (Child only) - Glucose
3 and 6 months
Improvement in HDL-C
Временное ограничение: 3 and 6 months
Biochemical measures (Child only) HDL-C
3 and 6 months
Improvement in Total Cholesterol
Временное ограничение: 3 and 6 months
Biochemical measures (Child only) -Total cholesterol will be measured using a point-of-care testing (POCT) and LDL-C will be calculated.
3 and 6 months
Improvement in cardio-metabolic variables
Временное ограничение: 3 and 6 months
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.
3 and 6 months
Blood Pressure (Child)
Временное ограничение: 3 and 6 months
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.
3 and 6 months
Blood Pressure (Parent(s)/guardian(s))
Временное ограничение: 3 and 6 months
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.
3 and 6 months

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University Hospitals, Leicester

Соавторы

University of Leipzig
Technische Universität Dresden
University of Leicester
The Algarve Regional Health Administration
Alexander Technological Educational Institute, Thessaloniki, Greece
Diabetes Centre of Paediatrics P&A
Primary Care Centre Egia, San Sebastian, Spain
Basque Government Department of Public Health
Health Department of the Alto/Bajo Deba
Associacao Protectora dos Diabeticos de Portugal

Следователи

  • Главный следователь: Melanie J Davies, MD, University Hospitals, Leicester

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 июля 2016 г.

Первичное завершение (Действительный)

1 марта 2017 г.

Завершение исследования (Действительный)

1 октября 2017 г.

Даты регистрации исследования

Первый отправленный

5 мая 2016 г.

Впервые представлено, что соответствует критериям контроля качества

22 июля 2016 г.

Первый опубликованный (Оценивать)

27 июля 2016 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

16 января 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 января 2019 г.

Последняя проверка

1 января 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 65436

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

Да

Описание плана IPD

Non identifiable participant data will be only be shared with the study collaborators.

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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