Type 1 Diabetes MellitusNCT02144337

Physical Activity in Children With Type 1 Diabetes Study

A study testing Steps To Active Kids (STAK) programme in people with Type 1 Diabetes Mellitus and Physical Activity, run by University of Nottingham at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 9 to 11 years
Conditions the study is for: Type 1 Diabetes Mellitus, Physical Activity
What is being tested?: Steps To Active Kids (STAK) programme
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited Kingdom
Study dates: May 2014to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Nottingham University Hospitals Nhs Trust
Nottingham

Other trials in United Kingdom

About this study

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

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).

Read the 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
Being tested: Steps To Active Kids (STAK) programme
Keywords: Physical activity, Type 1 Diabetes Mellitus, Children, Intervention
Medical subject headings: Diabetes Mellitus, Type 1, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Steps To Active Kids (STAK) programmeBehavioural
Intervention described in Arm/Group Description.

Study groups in NCT02144337
Study group	Role	What they receive
Intervention group	Experimental	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. Receives: Behavioral: Steps To Active Kids (STAK) programme
Control group	No intervention	Control group. Children in the Control group are asked to continue normal daily activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility: Response Rate
Number of participants completing outcome measures at T2
Measured: Response rate at T2
Feasibility: Response Rate
Number of participants completing outcome measures at T3
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 0 months (baseline) and 6 months (follow-up)
Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)
Measured: 0 months (baseline) and 6 months (follow-up)
Change in Clinical Outcome Measures (Hba1c, Height, Weight)
Data collected as routine clinic procedure and will be used to assess changes in HbA1c and BMI from baseline to follow-up.
Measured: 0 months (baseline) and 6 months (follow-up)
Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)
Measured: 0 months (baseline) and 6 months (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014May 2015

First posted22 May 2014 (estimated)
Study startMay 2014
Primary completionApr 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02144337
Sponsor's protocol ID: 14005
Status last verified: Jul 2015
First submitted: 16 Jan 2014
Last updated: 17 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29415687

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer
Diabetes Mellitus, Type 2, Cancer
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
Diabetes Mellitus, Type 1
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes

All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Feasibility of a Physical Activity Intervention for Children With Type 1 Diabetes Mellitus: Steps To Active Kids (STAK)
ClinicalTrials.gov ID: NCT02144337
Acronym / sponsor ID: 14005
Conditions: Type 1 Diabetes Mellitus, Physical Activity
Keywords: Physical activity, Type 1 Diabetes Mellitus, Children, Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of NottinghamUniversity, hospital or other
Study start: May 2014
Primary completion: Apr 2015 (actual)
Study completion: May 2015 (actual)
First posted: 22 May 2014 (estimated)
Results: Posted 17 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention group	Experimental	Behavioral: Steps To Active Kids (STAK) programmeSteps 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 intervention	–Control group. Children in the Control group are asked to continue normal daily activities.

Who may qualify

Ages: 9 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Steps To Active Kids (STAK) programmeIntervention described in Arm/Group Description.	Behavioural	Intervention group

Primary outcome

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.

4 secondary outcomes

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)
Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)
Time frame: 0 months (baseline) and 6 months (follow-up)

Results and safety

Results posted to the registry on 17 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	8	8
Control Group	5	5

Primary outcome: Feasibility: Response Rate

Time frame: Response rate at T2. Number. Unit: number of participants

Measure	Intervention Group n = 8	Control Group n = 5
Value	4	4

Primary outcome: Feasibility: Response Rate

Time frame: Response rate at T3. Number. Unit: Number of participants

Measure	Intervention Group n = 8	Control Group n = 5
Value	5	5

Primary outcome: Feasibility: Rate of Adherence to the Intervention

Time frame: Participants were monitored for the duration of the STAK programme (6 weeks). Number. Unit: percentage of the intervention group

Measure	Intervention Group n = 8
Value	75

Primary outcome: Feasibility: Number of Participants With Adverse Events

Time frame: Participants were followed from baseline to research completion. Number. Unit: number of participants

Measure	Overall Study Group Sample n = 13
Value	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data were collected throughout the course of the research (Baseline to completion).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Steps To Active Kids (STAK) Programme	0 of 8 (0%)	0 of 8 (0%)	Not reported
Normal Daily Activity	0 of 5 (0%)	0 of 5 (0%)	Not reported

Limitations and caveats (from the sponsor): Analysis and interpretation of secondary outcomes ongoing.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29415687Quirk 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.

Related trials for Type 1 Diabetes Mellitus

RecruitingObservational study
Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer
Diabetes Mellitus, Type 2, Cancer
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
Diabetes Mellitus, Type 1
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holly Blake principal investigator

University of Nottingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Steps To Active Kids (STAK) programme in people with Type 1 Diabetes Mellitus and Physical Activity, run by University of Nottingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Response Rate (time frame: Response rate at T2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02144337, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015; AzTrials last refreshed its copy on 30 Oct 2026.