Prevention Strategies for Adolescents at Risk of Diabetes - A Randomised Controlled Trial of an Interactive Family-based Lifestyle Programme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
研究概览
简要总结
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).
详细描述
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))
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
Intervention
The educational intervention participants will receive the eight 90 minute sessions of an interactive family based lifestyle programme.
干预措施: Interactive Lifestyle programme workshop (Behavioral)
结局指标
主要结局
The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
时间窗: 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.
次要结局
- 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)