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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02144337
Other study ID # 14005
Secondary ID
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


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
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