- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01067924
Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes
The purpose of the study is to assess the effectiveness of motivational interviewing in promoting maintenance of physical activity in people with Type 2 diabetes (T2D) upon the completion of a structured exercise program.
Participants with T2D who are new graduates of a supervised exercise program will be randomly assigned to either standard care (SC) or to standard care and in addition, participate in two individual motivational interview (MI) sessions (SC + MI).
The primary outcome will be change in physical activity behavior assessed by the Godin Leisure and Exercise questionnaire. Secondary outcomes will include change in blood glucose control (A1C), BMI, six minute walk-test, QoL, and self-efficacy.
Outcomes will be measured in groups at baseline, end of program, 3 months and 6 months post-program.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Alberta
-
Calgary, Alberta, Canada
- University of Calgary
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- a) self-reported physician diagnosed T2D, included are those who are treated with diet alone, oral medication and insulin
- b) clearance by Living Well clinical staff to exercise through GXT algorithm and triaged to "Keep Going" level class,
- c) at least 18 years of age,
- d) ability to read and write in English.
Exclusion Criteria:
- a) insulin therapy that began less than 2 years after T2D diagnosis,
- b) changes during the previous 2 months in oral hypoglycemic
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Standard for pleje
|
Intervention arm will receive 2 motivational interviewing session aimed at increasing maintenance of physical activity upon the completion of a supervised exercise program.
Motivational interviews will occur at the end of the structured program and at 3 months post program completion.
Outcomes will be collected at 6 months post-program.
|
Eksperimentel: Motiverende samtale
|
Intervention arm will receive 2 motivational interviewing session aimed at increasing maintenance of physical activity upon the completion of a supervised exercise program.
Motivational interviews will occur at the end of the structured program and at 3 months post program completion.
Outcomes will be collected at 6 months post-program.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in physical activity as measured by the GODIN physical activity questionnaire
Tidsramme: baseline, 3, 6 months post program
|
baseline, 3, 6 months post program
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Hemoglobin A1C, BMI, six minute walk-test, QoL, and self-efficacy.
Tidsramme: Baseline, 3, 6 months post-program
|
Baseline, 3, 6 months post-program
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ronald Sigal, University of Calgary
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 22490
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