Physical Activity in Children With Type 1 Diabetes Study

University of Nottingham13 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus Physical Activity

Interventions

Steps To Active Kids (STAK) programmeBEHAVIORAL

Intervention described in Arm/Group Description.

Eligibility

Sex: ALLMin age: 9 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (1)

Nottingham University Hospitals Nhs Trust

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Feasibility: Response Rate

Number of participants completing outcome measures at T2

Time frame: Response rate at T2

Feasibility: Response Rate

Number of participants completing outcome measures at T3

Time frame: 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.

Time frame: 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.

Time frame: Participants were followed from baseline to research completion

Secondary Outcomes

Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity)

Time frame: 0 months (baseline) and 6 months (follow-up)

Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)

Time frame: 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.

Time frame: 0 months (baseline) and 6 months (follow-up)

Data from ClinicalTrials.gov

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