N/A
Completed N=13
Physical Activity in Children With Type 1 Diabetes Study
Type 1 diabetes mellitus · Physical Activity
Source: ClinicalTrials.gov NCT02144337 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Feasibility: Response Rate — 4; 4 number of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: Response Rate |
5; 5 | — |
| PRIMARY Feasibility: Rate of Adherence to the Intervention |
75 | — |
| PRIMARY Feasibility: Number of Participants With Adverse Events |
— | — |
| SECONDARY Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity) |
— | — |
| SECONDARY Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire) |
— | — |
| SECONDARY Change in Clinical Outcome Measures (Hba1c, Height, Weight) |
— | — |
| SECONDARY Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02144337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.