Physical Activity in Children With Type 1 Diabetes Study

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144337
• Other study ID #: 14005
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: July 20, 2015
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 11 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Physical Activity
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Steps To Active Kids (STAK) programme
Intervention described in Arm/Group Description.

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals Nhs Trust	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Response Rate	Number of participants completing outcome measures at T2	Response rate at T2	No
Primary	Feasibility: Response Rate	Number of participants completing outcome measures at T3	Response rate at T3	No
Primary	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)	No
Primary	Feasibility: Number of Participants With Adverse Events	Number of participants experiencing and/or reporting adverse events.	Participants were followed from baseline to research completion	Yes
Secondary	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)	No
Secondary	Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)		0 months (baseline) and 6 months (follow-up)	No
Secondary	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)	No
Secondary	Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)		0 months (baseline) and 6 months (follow-up)	No