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Physical Activity in Children With Type 1 Diabetes Study

Not Applicable
Completed
Conditions
Physical Activity
Type 1 Diabetes Mellitus
Interventions
Behavioral: Steps To Active Kids (STAK) programme
Registration Number
NCT02144337
Lead Sponsor
University of Nottingham
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
13
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention groupSteps To Active Kids (STAK) programmeSteps 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.
Primary Outcome Measures
NameTimeMethod
Feasibility: Number of Participants With Adverse EventsParticipants were followed from baseline to research completion

Number of participants experiencing and/or reporting adverse events.

Feasibility: Rate of Adherence to the InterventionParticipants 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 RateResponse rate at T3

Number of participants completing outcome measures at T3

Secondary Outcome Measures
NameTimeMethod
Change in Clinical Outcome Measures (Hba1c, Height, Weight)0 months (baseline) and 6 months (follow-up)

Data collected as routine clinic procedure and will be used to assess changes in HbA1c and BMI from baseline to 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)

Trial Locations

Locations (1)

Nottingham University Hospitals Nhs Trust

🇬🇧

Nottingham, United Kingdom

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