PRE-STARt Intervention - Trial of an Interactive Family Based Lifestyle Programme
14 de enero de 2019 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
318
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Leicester, Reino Unido, LE4 5pW
- University Hospitals of Leicester
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 14 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: 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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Otro: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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An increase in total volume of physical activity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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))
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Melanie J Davies, MD, University Hospitals, Leicester
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2016
Finalización primaria (Actual)
1 de marzo de 2017
Finalización del estudio (Actual)
1 de octubre de 2017
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2016
Primero enviado que cumplió con los criterios de control de calidad
22 de julio de 2016
Publicado por primera vez (Estimar)
27 de julio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
14 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 65436
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
Non identifiable participant data will be only be shared with the study collaborators.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .