Physical Activity, Type 1 Diabetes Mellitus
Conditions
Keywords
Physical activity, Type 1 Diabetes Mellitus, Children, Intervention
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.
Interventions
BEHAVIORALSteps To Active Kids (STAK) programme
Intervention described in Arm/Group Description.
Sponsors
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Response Rate | Response rate at T2 | Number of participants completing outcome measures at T2 |
| Feasibility: Rate of Adherence to the Intervention | 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 | Participants were followed from baseline to research completion | Number of participants experiencing and/or reporting adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent) | 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) | Data collected as routine clinic procedure and will be used to assess changes in HbA1c and BMI from baseline to follow-up. |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment through clinic (single-centre). Postal invitation to all children meeting eligibility criteria.
Pre-assignment details
Expression of interest request. Consent (parental) and assent (child) received from those who expressed an interest and agreed to participate.
Participants by arm
| Arm | Count |
|---|---|
| Steps To Active Kids (STAK) Programme 6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).
Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity. | 8 |
| Normal Daily Activity Treatment as usual: children asked to continue normal daily activity as usual. | 5 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| T2 Follow-up (Post-intervention) | Lack of Efficacy | 1 | 1 |
| T2 Follow-up (Post-intervention) | Lost to Follow-up | 2 | 0 |
| T2 Follow-up (Post-intervention) | Withdrawal by Subject | 1 | 0 |
| T3 Follow-up (3 Month Post-intervention) | Lost to Follow-up | 2 | 0 |
| T3 Follow-up (3 Month Post-intervention) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Steps To Active Kids (STAK) Programme | Normal Daily Activity | Total |
|---|---|---|---|
| Age, Continuous | 10.1 years STANDARD_DEVIATION 0.8 | 10.0 years STANDARD_DEVIATION 1 | 10.1 years STANDARD_DEVIATION 0.9 |
| BMI | 19.5 kg/m^2 STANDARD_DEVIATION 3.8 | 20.5 kg/m^2 STANDARD_DEVIATION 3.4 | 19.9 kg/m^2 STANDARD_DEVIATION 3.5 |
| CSAPPA Adequacy | 22.4 units on a scale STANDARD_DEVIATION 1.8 | 20.0 units on a scale STANDARD_DEVIATION 4.5 | 21.5 units on a scale STANDARD_DEVIATION 3.1 |
| CSAPPA Enjoyment | 10.6 units on a scale STANDARD_DEVIATION 1.7 | 10.3 units on a scale STANDARD_DEVIATION 1.5 | 10.5 units on a scale STANDARD_DEVIATION 1.6 |
| CSAPPA Predilection | 28.7 units on a scale STANDARD_DEVIATION 4 | 29.0 units on a scale STANDARD_DEVIATION 5 | 28.8 units on a scale STANDARD_DEVIATION 4.1 |
| CSAPPA total | 61.7 units on a scale STANDARD_DEVIATION 5.7 | 59.3 units on a scale STANDARD_DEVIATION 9.9 | 60.8 units on a scale STANDARD_DEVIATION 7.1 |
| HbA1c (mmol/mol) | 57.1 mmol/mol STANDARD_DEVIATION 10.2 | 55.4 mmol/mol STANDARD_DEVIATION 11.8 | 56.5 mmol/mol STANDARD_DEVIATION 10.4 |
| PHFS Behaviour | 21.9 units on a scale STANDARD_DEVIATION 7.5 | 20.2 units on a scale STANDARD_DEVIATION 2.6 | 21.8 units on a scale STANDARD_DEVIATION 4.4 |
| PHFS total | 42.8 units on a scale STANDARD_DEVIATION 17.6 | 37.4 units on a scale STANDARD_DEVIATION 11.5 | 42.7 units on a scale STANDARD_DEVIATION 13.3 |
| PHFS Worry | 21.2 units on a scale STANDARD_DEVIATION 14.1 | 17.2 units on a scale STANDARD_DEVIATION 9.8 | 20.8 units on a scale STANDARD_DEVIATION 12.2 |
| Race/Ethnicity, Customized Black African | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Mixed race | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White British | 6 participants | 5 participants | 11 participants |
| Self-reported physical activity | 56.8 units on a scale STANDARD_DEVIATION 9.1 | 49.8 units on a scale STANDARD_DEVIATION 5.7 | 54.16 units on a scale STANDARD_DEVIATION 8.5 |
| Sex: Female, Male Female | 6 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
| Years diagnosed | 5.1 years STANDARD_DEVIATION 3.1 | 2.9 years STANDARD_DEVIATION 2.3 | 4.3 years STANDARD_DEVIATION 2.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 5 |
| serious Total, serious adverse events | 0 / 8 | 0 / 5 |
Outcome results
Primary
Feasibility: Number of Participants With Adverse Events
Number of participants experiencing and/or reporting adverse events.
Time frame: Participants were followed from baseline to research completion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Feasibility: Number of Participants With Adverse Events | 0 number of participants |
Primary
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.
Time frame: Participants were monitored for the duration of the STAK programme (6 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Feasibility: Rate of Adherence to the Intervention | 75 percentage of the intervention group |
Primary
Feasibility: Response Rate
Number of participants completing outcome measures at T2
Time frame: Response rate at T2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Feasibility: Response Rate | 4 number of participants |
| Control Group | Feasibility: Response Rate | 4 number of participants |
Primary
Feasibility: Response Rate
Number of participants completing outcome measures at T3
Time frame: Response rate at T3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Feasibility: Response Rate | 5 Number of participants |
| Control Group | Feasibility: Response Rate | 5 Number of participants |
Secondary
Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)
Time frame: 0 months (baseline) and 6 months (follow-up)
Secondary
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)
Secondary
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.
Time frame: 0 months (baseline) and 6 months (follow-up)
Secondary
Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)
Time frame: 0 months (baseline) and 6 months (follow-up)