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Trial record 1 of 1 for:    NCT02144337
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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
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Physical Activity Behavioral: Steps To Active Kids (STAK) programme Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Feasibility: Response Rate [ Time Frame: Response rate at T2 ]
    Number of participants completing outcome measures at T2

  2. Feasibility: Response Rate [ Time Frame: Response rate at T3 ]
    Number of participants completing outcome measures at T3

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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) ]
  2. Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire) [ Time Frame: 0 months (baseline) and 6 months (follow-up) ]
  3. 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.

  4. Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent) [ Time Frame: 0 months (baseline) and 6 months (follow-up) ]


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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, United Kingdom
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Holly Blake University of Nottingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02144337    
Other Study ID Numbers: 14005
First Posted: May 22, 2014    Key Record Dates
Results First Posted: August 17, 2015
Last Update Posted: August 17, 2015
Last Verified: July 2015
Keywords provided by University of Nottingham:
Physical activity
Type 1 Diabetes Mellitus
Children
Intervention
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases