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Physical Activity in Children With Type 1 Diabetes Study

20. juli 2015 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 år til 11 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Steps To Active Kids (STAK) programme
Intervention described in Arm/Group Description.
Ingen indgriben: Control group
Control group. Children in the Control group are asked to continue normal daily activities.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility: Response Rate
Tidsramme: Response rate at T2
Number of participants completing outcome measures at T2
Response rate at T2
Feasibility: Response Rate
Tidsramme: Response rate at T3
Number of participants completing outcome measures at T3
Response rate at T3
Feasibility: Rate of Adherence to the Intervention
Tidsramme: 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.
Participants were monitored for the duration of the STAK programme (6 weeks)
Feasibility: Number of Participants With Adverse Events
Tidsramme: Participants were followed from baseline to research completion
Number of participants experiencing and/or reporting adverse events.
Participants were followed from baseline to research completion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity)
Tidsramme: 0 months (baseline) and 6 months (follow-up)
0 months (baseline) and 6 months (follow-up)
Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)
Tidsramme: 0 months (baseline) and 6 months (follow-up)
0 months (baseline) and 6 months (follow-up)
Change in Clinical Outcome Measures (Hba1c, Height, Weight)
Tidsramme: 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.
0 months (baseline) and 6 months (follow-up)
Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)
Tidsramme: 0 months (baseline) and 6 months (follow-up)
0 months (baseline) and 6 months (follow-up)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Nottingham

Efterforskere

  • Ledende efterforsker: Holly Blake, University of Nottingham

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2014

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

16. januar 2014

Først indsendt, der opfyldte QC-kriterier

19. maj 2014

Først opslået (Skøn)

22. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14005

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fysisk aktivitet

Kliniske forsøg med Steps To Active Kids (STAK) programme

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