The Feasibility of a Physical Activity Intervention for Children With Type 1 Diabetes Mellitus: Steps To Active Kids (STAK)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- University of Nottingham
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Feasibility: Number of Participants With Adverse Events
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Feasibility: Number of Participants With Adverse Events
Time Frame: Participants were followed from baseline to research completion
Number of participants experiencing and/or reporting adverse events.
Feasibility: Rate of Adherence to the Intervention
Time Frame: 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
Time Frame: Response rate at T3
Number of participants completing outcome measures at T3
Secondary Outcomes
- 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))