Clinical trial NCT02144337: Physical Activity in Children With Type 1 Diabetes Study
Official title: The Feasibility of a Physical Activity Intervention for Children With Type 1 Diabetes Mellitus: Steps To Active Kids (STAK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Physical Activity
Keywords: Physical activity
Type 1 Diabetes Mellitus
Children
Intervention
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 13
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Feasibility: Response Rate
timeFrame: Response rate at T2
measure: Feasibility: Response Rate
timeFrame: Response rate at T3
measure: Feasibility: Rate of Adherence to the Intervention
timeFrame: Participants were monitored for the duration of the STAK programme (6 weeks)
measure: Feasibility: Number of Participants With Adverse Events
timeFrame: Participants were followed from baseline to research completion
Secondary outcomes:
measure: Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity)
timeFrame: 0 months (baseline) and 6 months (follow-up)
measure: Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)
timeFrame: 0 months (baseline) and 6 months (follow-up)
measure: Change in Clinical Outcome Measures (Hba1c, Height, Weight)
timeFrame: 0 months (baseline) and 6 months (follow-up)
measure: Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)
timeFrame: 0 months (baseline) and 6 months (follow-up)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Nhs Trust
Study officials:
affiliation: University of Nottingham
name: Holly Blake
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quirk H, Glazebrook C, Blake H. A physical activity intervention for children with type 1 diabetes- steps to active kids with diabetes (STAK-D): a feasibility study. BMC Pediatr. 2018 Feb 7;18(1):37. doi: 10.1186/s12887-018-1036-8.