Prevention Strategies for Adolescents at Risk of Diabetes - A Randomised Controlled Trial of an Interactive Family-based Lifestyle Programme
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- University Hospitals, Leicester
- Enrollment
- 318
- Locations
- 1
- Primary Endpoint
- The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
Time Frame: 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.
Secondary Outcomes
- An increase in total volume of physical activity(3 and 6 months)
- Improvement in HbA1c(3 and 6 months)
- Reduction in time spent sedentary(3 and 6 months)
- Change in physical activity levels(3 and 6 months)
- Improvement in Triglycerides(3 and 6 months)
- Blood Pressure (Child)(3 and 6 months)
- Improvement in Total Cholesterol(3 and 6 months)
- Improvement in HDL-C(3 and 6 months)
- An increase in the proportion meeting MVPA guidelines(3 and 6 months)
- Improvement in diet composition(3 and 6 months)
- Improvement in cardio-metabolic variables(3 and 6 months)
- Reduction in Body mass index percentile (BMI)(3 and 6 months)
- Change in healthy food provision and parenting practices for healthy food(3 and 6 months)
- Improvement in knowledge of physical activity and nutrition(3 and 6 months)
- Improvement in Glucose(3 and 6 months)
- Blood Pressure (Parent(s)/guardian(s))(3 and 6 months)