Physical Activity in Children With Type 1 Diabetes Study

NCT ID: NCT02144337

Last Updated: 2015-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-05-31

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).

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.

Conditions

Type 1 Diabetes Mellitus; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Steps To Active Kids (STAK) programme

Intervention Type: BEHAVIORAL

Intervention described in Arm/Group Description.

Control group

Control group. Children in the Control group are asked to continue normal daily activities.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Steps To Active Kids (STAK) programme

Intervention described in Arm/Group Description.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holly Blake

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Nottingham University Hospitals Nhs Trust

Nottingham, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 29415687 (View on PubMed)

Other Identifiers

14005

Identifier Type: -

Identifier Source: org_study_id