Physical Activity in Children With Type 1 Diabetes Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Feasibility of a Physical Activity Intervention for Children With Type 1 Diabetes Mellitus: Steps To Active Kids (STAK)

Conditions
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Type 1 Diabetes Mellitus, Physical Activity

Intervention / Treatment
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* Behavioral: Steps To Active Kids (STAK) programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Steps To Active Kids (STAK) programme (6 weeks) includes: StreetDance DVD designed to be completed at home (4 weeks in total). A dance routine is taught over 4 weeks with new elements introduced each day. Activity diary aims to encourage children to record daily activities in a logbook and to educate children about physical activity. Step counter: Children are given a pedometer and encouraged to record steps in the activity diary and to set personal goals to increase their steps. Weekly group activity sessions for 4 - 6 weeks. Involve a circuit of activity stations varying in intensity. The group sessions are designed to be fun and non-competitive. Children can record their scores at each station and monitor their own progress. | Behavioral: Steps To Active Kids (STAK) programme<br>* Intervention described in Arm/Group Description.<br>|
| No Intervention: Control group<br>Control group. Children in the Control group are asked to continue normal daily activities. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Response Rate | Number of participants completing outcome measures at T2 | Response rate at T2 | 
| Feasibility: Response Rate | Number of participants completing outcome measures at T3 | Response rate at T3 | 
| Feasibility: Rate of Adherence to the Intervention | Attendance at physical activity sessions and completion of activity diary Intervention group only as the Control group were not exposed to any intervention. | Participants were monitored for the duration of the STAK programme (6 weeks) | 
| Feasibility: Number of Participants With Adverse Events | Number of participants experiencing and/or reporting adverse events. | Participants were followed from baseline to research completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Clinical Outcome Measures (Hba1c, Height, Weight) | Data collected as routine clinic procedure and will be used to assess changes in HbA1c and BMI from baseline to follow-up. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Type 1 Diabetes Mellitus, Children, Intervention