The Feasibility of a Physical Activity Intervention for Children With Type 1 Diabetes Mellitus: Steps To Active Kids (STAK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Feasibility: Number of Participants With Adverse Events
研究概览
简要总结
This study aims to test the feasibility of a physical activity intervention called the Steps To Active Kids (STAK) programme in children aged 9 - 11 years with Type 1 Diabetes Mellitus (T1DM).
详细描述
The STAK programme promotes physical activity in children who have a chronic condition, low levels of physical activity, are overweight or who lack confidence to take part in physical activity. The intervention involves an Activity Diary, circuit training, pedometer step counting, daily physical activity monitoring and goal setting to promote long-term increases in physical activity and its associated health benefits. This randomised single-centre feasibility study will test whether the STAK programme is feasible for children with T1DM, in terms of acceptability, attractiveness and compliance and a qualitative process evaluation will aid the assessment of feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be aged between 9 and 11 years
- •Have a clinical diagnosis of Type 1 Diabetes Mellitus for at least 3 months
- •Be willing and able to comply with the study protocol
- •Be physically able to participate in physical activity
- •Have a parent/carer who provides informed consent
排除标准
- •Be under the age of 9 years and over the age of 11 years
- •Have been diagnosed with Type 1 Diabetes Mellitus for less than 3 months
- •Have an injury or physical health condition that precludes their participation in physical activity
- •Have a psychiatric disorder that interferes with provision of assent, completion of measurements, intervention, or follow-up
- •Insufficient proficiency in English to comply with treatment or provide data
结局指标
主要结局
Feasibility: Number of Participants With Adverse Events
时间窗: Participants were followed from baseline to research completion
Number of participants experiencing and/or reporting adverse events.
Feasibility: Rate of Adherence to the Intervention
时间窗: Participants were monitored for the duration of the STAK programme (6 weeks)
Attendance at physical activity sessions and completion of activity diary Intervention group only as the Control group were not exposed to any intervention.
Feasibility: Response Rate
时间窗: Response rate at T3
Number of participants completing outcome measures at T3
次要结局
- Change in Clinical Outcome Measures (Hba1c, Height, Weight)(0 months (baseline) and 6 months (follow-up))
- Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity)(0 months (baseline) and 6 months (follow-up))
- Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)(0 months (baseline) and 6 months (follow-up))
- Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)(0 months (baseline) and 6 months (follow-up))