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Completed

NCT Number: NCT02144337

Physical Activity in Children With Type 1 Diabetes Study

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).

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Physical Activity

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham University Hospitals Nhs Trust

Nottingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Steps To Active Kids (STAK) programme

Behavioral

Intervention described in Arm/Group Description.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 22, 2014
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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