Trial Outcomes & Findings for Physical Activity in Children With Type 1 Diabetes Study (NCT NCT02144337)
NCT ID: NCT02144337
Last Updated: 2015-08-17
Results Overview
Number of participants completing outcome measures at T2
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Response rate at T2
Results posted on
2015-08-17
Participant Flow
Recruitment through clinic (single-centre). Postal invitation to all children meeting eligibility criteria.
Expression of interest request. Consent (parental) and assent (child) received from those who expressed an interest and agreed to participate.
Participant milestones
| Measure |
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.
|
Control Group
Control group. Children in the Control group are asked to continue normal daily activities.
|
|---|---|---|
|
Baseline 0 Months
STARTED
|
8
|
5
|
|
Baseline 0 Months
COMPLETED
|
8
|
5
|
|
Baseline 0 Months
NOT COMPLETED
|
0
|
0
|
|
T2 Follow-up (Post-intervention)
STARTED
|
8
|
5
|
|
T2 Follow-up (Post-intervention)
COMPLETED
|
4
|
4
|
|
T2 Follow-up (Post-intervention)
NOT COMPLETED
|
4
|
1
|
|
T3 Follow-up (3 Month Post-intervention)
STARTED
|
8
|
5
|
|
T3 Follow-up (3 Month Post-intervention)
COMPLETED
|
5
|
5
|
|
T3 Follow-up (3 Month Post-intervention)
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Control Group
Control group. Children in the Control group are asked to continue normal daily activities.
|
|---|---|---|
|
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
Physical Activity in Children With Type 1 Diabetes Study
Baseline characteristics by cohort
| Measure |
Steps To Active Kids (STAK) Programme
n=8 Participants
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.
|
Normal Daily Activity
n=5 Participants
Treatment as usual: children asked to continue normal daily activity as usual.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.1 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
10.0 years
STANDARD_DEVIATION 1 • n=7 Participants
|
10.1 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White British
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black African
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
BMI
|
19.5 kg/m^2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
20.5 kg/m^2
STANDARD_DEVIATION 3.4 • n=7 Participants
|
19.9 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Years diagnosed
|
5.1 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
2.9 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
4.3 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Self-reported physical activity
|
56.8 units on a scale
STANDARD_DEVIATION 9.1 • n=5 Participants
|
49.8 units on a scale
STANDARD_DEVIATION 5.7 • n=7 Participants
|
54.16 units on a scale
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
CSAPPA total
|
61.7 units on a scale
STANDARD_DEVIATION 5.7 • n=5 Participants
|
59.3 units on a scale
STANDARD_DEVIATION 9.9 • n=7 Participants
|
60.8 units on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
CSAPPA Adequacy
|
22.4 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
20.0 units on a scale
STANDARD_DEVIATION 4.5 • n=7 Participants
|
21.5 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
CSAPPA Predilection
|
28.7 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
29.0 units on a scale
STANDARD_DEVIATION 5.0 • n=7 Participants
|
28.8 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
CSAPPA Enjoyment
|
10.6 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
10.3 units on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
10.5 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
PHFS total
|
42.8 units on a scale
STANDARD_DEVIATION 17.6 • n=5 Participants
|
37.4 units on a scale
STANDARD_DEVIATION 11.5 • n=7 Participants
|
42.7 units on a scale
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
PHFS Behaviour
|
21.9 units on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
20.2 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
21.8 units on a scale
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
PHFS Worry
|
21.2 units on a scale
STANDARD_DEVIATION 14.1 • n=5 Participants
|
17.2 units on a scale
STANDARD_DEVIATION 9.8 • n=7 Participants
|
20.8 units on a scale
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
HbA1c (mmol/mol)
|
57.1 mmol/mol
STANDARD_DEVIATION 10.2 • n=5 Participants
|
55.4 mmol/mol
STANDARD_DEVIATION 11.8 • n=7 Participants
|
56.5 mmol/mol
STANDARD_DEVIATION 10.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Response rate at T2Number of participants completing outcome measures at T2
Outcome measures
| Measure |
Intervention Group
n=8 Participants
Steps To Active Kids (STAK) programme
|
Control Group
n=5 Participants
No intervention
|
|---|---|---|
|
Feasibility: Response Rate
|
4 number of participants
|
4 number of participants
|
PRIMARY outcome
Timeframe: Response rate at T3Number of participants completing outcome measures at T3
Outcome measures
| Measure |
Intervention Group
n=8 Participants
Steps To Active Kids (STAK) programme
|
Control Group
n=5 Participants
No intervention
|
|---|---|---|
|
Feasibility: Response Rate
|
5 Number of participants
|
5 Number of participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
Steps To Active Kids (STAK) programme
|
Control Group
No intervention
|
|---|---|---|
|
Feasibility: Rate of Adherence to the Intervention
|
75 percentage of the intervention group
|
—
|
PRIMARY outcome
Timeframe: Participants were followed from baseline to research completionNumber of participants experiencing and/or reporting adverse events.
Outcome measures
| Measure |
Intervention Group
n=13 Participants
Steps To Active Kids (STAK) programme
|
Control Group
No intervention
|
|---|---|---|
|
Feasibility: Number of Participants With Adverse Events
|
0 number of participants
|
—
|
SECONDARY outcome
Timeframe: 0 months (baseline) and 6 months (follow-up)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 months (baseline) and 6 months (follow-up)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 months (baseline) and 6 months (follow-up)Outcome measures
Outcome data not reported
Adverse Events
Steps To Active Kids (STAK) Programme
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Daily Activity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place