Physical Activity in Children With Type 1 Diabetes Study
The Feasibility of a Physical Activity Intervention for Children With Type 1 Diabetes Mellitus: Steps To Active Kids (STAK)
1 other identifier
interventional
13
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
August 17, 2015
CompletedAugust 17, 2015
July 1, 2015
11 months
January 16, 2014
May 27, 2015
July 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Feasibility: Response Rate
Number of participants completing outcome measures at T2
Response rate at T2
Feasibility: Response Rate
Number of participants completing outcome measures at T3
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.
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.
Participants were followed from baseline to research completion
Secondary Outcomes (4)
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 Clinical Outcome Measures (Hba1c, Height, Weight)
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)
Study Arms (2)
Intervention group
EXPERIMENTALSteps 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.
Control group
NO INTERVENTIONControl group. Children in the Control group are asked to continue normal daily activities.
Interventions
Intervention described in Arm/Group Description.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nottingham University Hospitals Nhs Trust
Nottingham, United Kingdom
Related Publications (1)
Quirk H, Glazebrook C, Blake H. A physical activity intervention for children with type 1 diabetes- steps to active kids with diabetes (STAK-D): a feasibility study. BMC Pediatr. 2018 Feb 7;18(1):37. doi: 10.1186/s12887-018-1036-8.
PMID: 29415687DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Analysis and interpretation of secondary outcomes ongoing.
Results Point of Contact
- Title
- Helen Quirk
- Organization
- University of Nottingham (UK)
Study Officials
- PRINCIPAL INVESTIGATOR
Holly Blake
University of Nottingham
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2014
First Posted
May 22, 2014
Study Start
May 1, 2014
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
August 17, 2015
Results First Posted
August 17, 2015
Record last verified: 2015-07