Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | No Intervention | Control group. Children in the Control group are asked to continue normal daily activities. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steps To Active Kids (STAK) programme | Behavioral | Intervention described in Arm/Group Description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Response Rate | Number of participants completing outcome measures at T2 | Response rate at T2 |
| Feasibility: Response Rate | Number of participants completing outcome measures at T3 | 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. | 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. | Participants were followed from baseline to research completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Holly Blake | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals Nhs Trust | Nottingham | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29415687 | Derived | 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. |
Not provided
Not provided
Expression of interest request. Consent (parental) and assent (child) received from those who expressed an interest and agreed to participate.
Recruitment through clinic (single-centre). Postal invitation to all children meeting eligibility criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | 6 week Steps To Active Kids (STAK) programme 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. |
| FG001 | Control Group | Control group. Children in the Control group are asked to continue normal daily activities. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline 0 Months |
| |||||||||||||
| T2 Follow-up (Post-intervention) |
| |||||||||||||
| T3 Follow-up (3 Month Post-intervention) |
|
All participants were included in the analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility: Response Rate | Number of participants completing outcome measures at T2 | Posted | Number | number of participants | Response rate at T2 |
|
|
Data were collected throughout the course of the research (Baseline to completion).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Analysis and interpretation of secondary outcomes ongoing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helen Quirk | University of Nottingham (UK) | 01157484325 | ntxhq1@nottingham.ac.uk |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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) |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| Normal Daily Activity |
Treatment as usual: children asked to continue normal daily activity as usual. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| BMI | Body mass index (calculated from height (cm) and weight (kg) measures from clinic records) | Mean | Standard Deviation | kg/m^2 |
|
| Years diagnosed | Mean | Standard Deviation | years |
|
| Self-reported physical activity | Children rate a range of activities on a three-point scale representing how much of that activity they did (none, a little, a lot) at three time points in the previous 24 hours; today before school (22 items), yesterday after school (22 items), and yesterday during school (11 items). Scores are summed to form a total score for physical activities (possible range 41-123). Higher values represent higher physical activity (i.e., better outcome). | Mean | Standard Deviation | units on a scale |
|
| CSAPPA total | CSAPPA = Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity The CSAPPA scale measures generalised self-efficacy and attitudes towards participation in physical activity. The 19-item CSAPPA scale measures children's perceived adequacy, predilection and enjoyment towards physical activity. Each item is scored from 1 to 4 and total CSAPPA scores range between 19 - 76 with higher scores indicative of greater self-efficacy (i.e., better outcome). Total score calculated as the sum of all sub-scales (CSAPPA adequacy + CSAPPA predilection + CSAPPA enjoyment) | Mean | Standard Deviation | units on a scale |
|
| CSAPPA Adequacy | Perceived adequacy (7 items) refers to the perception of one's ability to achieve some acceptable standard of success, that standard being influenced by the self, parents, peers, teachers and society's expectations. Range of scores 7 - 28, with higher scores indicating higher perceived adequacy (i.e., better outcome). | Mean | Standard Deviation | units on a scale |
|
| CSAPPA Predilection | Predilection (9 items) refers to the preference for being active over being sedentary when given the choice. Range of scores 9 - 36 with higher scores indicating higher predilection towards physical activity (i.e., better outcome). | Mean | Standard Deviation | units on a scale |
|
| CSAPPA Enjoyment | Enjoyment (3 items) refers to enjoyment of Physical Education (P.E.) class. Range of scores 2 - 12 with higher scores indicating greater enjoyment of P.E (i.e., better outcome). | Mean | Standard Deviation | units on a scale |
|
| PHFS total | PHFS = Parents' Hypoglycaemia Fear Survey The 26-item PHFS measured parents' fear of hypoglycaemia and the negative consequences of these episodes, as well as behaviours used to avoid hypoglycaemia and its negative consequences. The measure comprises a behaviour subscale and a worry subscale. Total score calculated as the sum of both sub-scales (PHFS Behaviour + PHFS Worry). Scores range from 0-104. Higher score indicates greater fear of hypoglycaemia (i.e., worse outcome). | Mean | Standard Deviation | units on a scale |
|
| PHFS Behaviour | 11 items on the PHFS-behaviour subscale assess the behaviours that parents may engage in as a result of fear of hypoglycaemia (e.g., 'avoid having my child being alone when his/her sugar is likely to be low'). Items refer to diabetes management behaviours parents may perform to reduce the chance of hypoglycaemia, the tendency to keep blood glucose levels high to avoid hypoglycaemia and behaviours aimed at avoiding the negative consequences of hypoglycaemia. Scores range from 0-44. Higher score indicates more hypoglycaemia avoidance behaviours (i.e., worse outcome). | Mean | Standard Deviation | units on a scale |
|
| PHFS Worry | 15 items on the PHFS-worry subscale address specific worries that parents may have in relation to various aspects of hypoglycaemia (e.g., 'child not having food, fruit or juice with him/her'). Items on the worry subscale assess worry about hypoglycaemia occurring when the child is alone or when there is no food or drink available, worry about the child having an accident or physical injury, and worry about the child being unable to function normally. Scores on the worry subscale range from 0-60. Higher score indicates greater worry (i.e., worse outcome). | Mean | Standard Deviation | units on a scale |
|
| HbA1c (mmol/mol) | Glycaemic control measured in mmol/mol. UK recommended level for good diabetes control is currently <58mmol/mol for children. Higher score indicates worse outcome. Lower score (<58mmol/mol) indicates better outcome. | Mean | Standard Deviation | mmol/mol |
|
|
| Primary | Feasibility: Response Rate | Number of participants completing outcome measures at T3 | Posted | Number | Number of participants | Response rate at T3 |
|
|
|
| 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. | Posted | Number | percentage of the intervention group | Participants were monitored for the duration of the STAK programme (6 weeks) |
|
|
|
| Secondary | Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity) | Not Posted | 0 months (baseline) and 6 months (follow-up) |
| Secondary | Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire) | Not Posted | 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. | Not Posted | 0 months (baseline) and 6 months (follow-up) |
| Secondary | Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent) | Not Posted | 0 months (baseline) and 6 months (follow-up) |
| Primary | Feasibility: Number of Participants With Adverse Events | Number of participants experiencing and/or reporting adverse events. | Posted | Number | number of participants | Participants were followed from baseline to research completion |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Normal Daily Activity | Treatment as usual: children asked to continue normal daily activity as usual. | 0 | 5 | 0 | 5 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |