Physical Activity in Children With Type 1 Diabetes Study
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|ClinicalTrials.gov Identifier: NCT02144337|
Recruitment Status : Completed
First Posted : May 22, 2014
Results First Posted : August 17, 2015
Last Update Posted : August 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Physical Activity||Behavioral: Steps To Active Kids (STAK) programme||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Feasibility of a Physical Activity Intervention for Children With Type 1 Diabetes Mellitus: Steps To Active Kids (STAK)|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||May 2015|
Experimental: Intervention group
Steps 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.
Behavioral: Steps To Active Kids (STAK) programme
Intervention described in Arm/Group Description.
No Intervention: Control group
Control group. Children in the Control group are asked to continue normal daily activities.
- Feasibility: Response Rate [ Time Frame: Response rate at T2 ]Number of participants completing outcome measures at T2
- Feasibility: Response Rate [ Time Frame: Response rate at T3 ]Number of participants completing outcome measures at T3
- Feasibility: Rate of Adherence to the Intervention [ Time Frame: Participants 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: Number of Participants With Adverse Events [ Time Frame: Participants were followed from baseline to research completion ]Number of participants experiencing and/or reporting adverse events.
- 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) [ Time Frame: 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 Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent) [ Time Frame: 0 months (baseline) and 6 months (follow-up) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144337
|Nottingham University Hospitals Nhs Trust|
|Nottingham, United Kingdom|
|Principal Investigator:||Holly Blake||University of Nottingham|