- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01589835
Preventing Diabetes in Those at Risk by Having a Facilitator and Family Doctor Encourage Healthy Activity and Eating Habits (FLIP)
4. marts 2014 opdateret af: University of British Columbia
Preventing Diabetes With Facilitated Lifestyle Intervention Prescriptions.Phase 2: Pilot Study
Nearly six million Canadians are living with an increased risk of diabetes (prediabetes) and approximately 50% of these will develop type 2 diabetes within five years.
The investigators wish to help these people change their lifestyle, to prevent them from getting diabetes.
Trials have shown that by supporting people with prediabetes to be more active and have healthier eating habits they can halve their risk.
However, these interventions were very costly and not performed in Canada.
With the help of local Family Physicians and other health professionals (e.g.
physiotherapy, psychology, endocrinology, nursing) the investigators have created a less expensive intervention suitable for the Canadian population and health system.
The investigators need to perform a study to see whether these modified approaches are practical for Canadians and likely to be effective.
People at risk will be invited to participate from family practices that have helped us in the initial stages of this program.
Family practices will be randomized to giving either the study intervention or continue with the physician's usual care.
People receiving the intervention will have an appointment with their family doctor to discuss their exercise and eating habits and agree changes that are necessary.
A prescription detailing these changes will be completed and signed by the family physician and participant.
Participants will be given the name of a lifestyle change facilitator (LCF) who will receive a copy of the prescription and contact the participant to help them set achievable goals.
The LCF will contact participants once a month for six months to help them achieve these goals.
The investigators eventual aim is to test this intervention in a large-scale randomized control trial.
To achieve this it is necessary to pilot all aspects of the trial.
Information from the pilot study can then be used to design and perform a large-scale study effectively.
The investigators hope that eventually the numbers of Canadians progressing to having diabetes will be reduced.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
59
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z3
- UBC Family Practice
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adults aged ≥ 18 years
- HbA1c of 5.7 to 6.4% and/or FPG of 6.1 to 6.9 mmol/l and/or a 2hr 75g OGTT of between 7.8 and 11.0 mmol/l
Exclusion Criteria:
- People with Type I or II diabetes
- Unstable angina
- Uncontrolled congestive heart failure
- Unstable arrhythmia
- Heart valvular disease
- Severe hypertension (systolic ≥ 200 or diastolic ≥ 120)
- Pregnant women or planning pregnancy within two years
- Life expectancy < 1 year
- Waiting for major surgery
- High risk of fracture
- Pregnancy or planning pregnancy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Sædvanlig pleje
|
Green prescription with support from facilitator
|
|
Eksperimentel: Lifestyle counseling
Green prescription with facilitator support
|
Green prescription with support from facilitator
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
HbA1c Progression to diabetes
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Martin Dawes, UBC
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. juli 2012
Primær færdiggørelse (Faktiske)
1. oktober 2013
Datoer for studieregistrering
Først indsendt
30. april 2012
Først indsendt, der opfyldte QC-kriterier
1. maj 2012
Først opslået (Skøn)
2. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H12-01330
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 Lifestyle changes
-
Chang Gung Memorial HospitalTilmelding efter invitation
-
Chang Gung Memorial HospitalAfsluttetSystolisk dysfunktion i venstre ventrikelTaiwan
-
Chang Gung Memorial HospitalTilmelding efter invitation
-
Inner Mongolia Yili Industrial Group Co., LtdAfsluttetDyspepsi | Mavesmerter | Forstoppelse | Luft i mavenKina
-
Chang Gung Memorial HospitalAfsluttet
-
Xiyuan Hospital of China Academy of Chinese Medical...UkendtIkke-erosiv reflukssygdom/diarré irritabel tyktarmKina
-
Chang Gung Memorial HospitalTilmelding efter invitationMyokardieinfarkt | Venstre bundt-grenblok | Atrieflimren | Venstre ventrikulær hypertrofi | Langt QT syndrom | Sinus Bradykardi | Højre bundt-grenblok | Sinus takykardi | For tidlige atrielle komplekser | For tidlige ventrikulære komplekserTaiwan
-
Chang Gung Memorial HospitalIkke rekrutterer endnuIkke-alkoholisk fedtleversygdom
-
Chung Shan Medical UniversityAfsluttetForhøjet blodtryk
-
Otsuka Beijing Research InstituteAfsluttet