Physical Activity in Children With Type 1 Diabetes Study
20 juli 2015 uppdaterad av: University of Nottingham
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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
13
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Nottingham, Storbritannien
- Nottingham University Hospitals NHS Trust
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
9 år till 11 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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Intervention described in Arm/Group Description.
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Inget ingripande: Control group
Control group.
Children in the Control group are asked to continue normal daily activities.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Feasibility: Response Rate
Tidsram: Response rate at T2
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Number of participants completing outcome measures at T2
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Response rate at T2
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Feasibility: Response Rate
Tidsram: Response rate at T3
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Number of participants completing outcome measures at T3
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Response rate at T3
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Feasibility: Rate of Adherence to the Intervention
Tidsram: Participants were monitored for the duration of the STAK programme (6 weeks)
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Attendance at physical activity sessions and completion of activity diary Intervention group only as the Control group were not exposed to any intervention.
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Participants were monitored for the duration of the STAK programme (6 weeks)
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Feasibility: Number of Participants With Adverse Events
Tidsram: Participants were followed from baseline to research completion
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Number of participants experiencing and/or reporting adverse events.
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Participants were followed from baseline to research completion
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity)
Tidsram: 0 months (baseline) and 6 months (follow-up)
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0 months (baseline) and 6 months (follow-up)
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Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)
Tidsram: 0 months (baseline) and 6 months (follow-up)
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0 months (baseline) and 6 months (follow-up)
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Change in Clinical Outcome Measures (Hba1c, Height, Weight)
Tidsram: 0 months (baseline) and 6 months (follow-up)
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Data collected as routine clinic procedure and will be used to assess changes in HbA1c and BMI from baseline to follow-up.
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0 months (baseline) and 6 months (follow-up)
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Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)
Tidsram: 0 months (baseline) and 6 months (follow-up)
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0 months (baseline) and 6 months (follow-up)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Holly Blake, University of Nottingham
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2014
Primärt slutförande (Faktisk)
1 april 2015
Avslutad studie (Faktisk)
1 maj 2015
Studieregistreringsdatum
Först inskickad
16 januari 2014
Först inskickad som uppfyllde QC-kriterierna
19 maj 2014
Första postat (Uppskatta)
22 maj 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 augusti 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juli 2015
Senast verifierad
1 juli 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14005
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