- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00677937
A Diabetes Prevention Study Targeting High Risk Individuals With Education and Ongoing Support (PREVENTION)
A Randomised Controlled Trial to Investigate an Educational Programme and Continuous Monitoring to Prevent Diabetes in Individuals With Screen Detected Pre-diabetes in a Multi-ethnic Population
The study aims to identify people at high diabetes risk within the local population and then implement and evaluate a pragmatic and low-cost diabetes prevention programme containing structured education on lifestyle, physical activity and food choices. An ongoing support framework will continue to reinforce and maintain the participant's individual goals to prevent the development of diabetes and reduce cardiovascular risk.
Therefore the principal question is: can we significantly reduce the incidence of diabetes through structured education in a high risk multi-ethnic UK population?
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Leicestershire
-
Leicester, Leicestershire, Det Forenede Kongerige, LE1 5WW
- University Hospitals of Leicester
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Patients that will be included into the study if they have either / or
- Diagnosed with Pre-Diabetes (IGT or IFG)
- Aged 40 - 75 if English speaking European or 25 - 75 if South Asian
- Able to attend group education sessions
Exclusion Criteria:
Patients will be excluded from the study if they are:
- Unable to give consent
- Unable to attend group education sessions
- Diagnosis of diabetes at screening or during the study
- Require an interpreter for language other than South Asian
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
Intervention to include education and ongoing support
|
6 hours of education with 1 month of inclusion, 3 years of ongoing support including annual refresher sessions
|
Ingen indgriben: 2
Control to receive standard care
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Reduction in incidence of diabetes at 3 years
Tidsramme: 3 years from entry into the study
|
3 years from entry into the study
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
change in hba1c, fasting and post glucose levels, cardiovascular risk (framingham), presence of MetS (NCEP ATP III)
Tidsramme: 3 years from enrollment into the study
|
3 years from enrollment into the study
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Melanie Davies, MD, FRCP, University Hospitals, Leicester
- Ledende efterforsker: Kamlesh Khunti, Univeristy of Leicester
Publikationer og nyttige links
Generelle publikationer
- Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.
- Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials. Diabetes Care. 2019 Oct;42(10):1847-1853. doi: 10.2337/dc19-0400. Epub 2019 Aug 9.
- Yates T, Henson J, Edwardson C, Bodicoat DH, Davies MJ, Khunti K. Differences in levels of physical activity between White and South Asian populations within a healthcare setting: impact of measurement type in a cross-sectional study. BMJ Open. 2015 Jul 23;5(7):e006181. doi: 10.1136/bmjopen-2014-006181.
- Gray LJ, Khunti K, Williams S, Goldby S, Troughton J, Yates T, Gray A, Davies MJ; Let's Prevent Collaborators. Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation. Cardiovasc Diabetol. 2012 May 20;11:56. doi: 10.1186/1475-2840-11-56.
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
- UHL10564
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 Type 2 diabetes mellitus
-
AstraZenecaRekruttering
-
Daewoong Pharmaceutical Co. LTD.Ikke rekrutterer endnuT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRekrutteringType 2 diabetes mellitus (T2DM)Kina
-
Newsoara Biopharma Co., Ltd.RekrutteringT2DM (Type 2 Diabetes Mellitus)Kina
-
Shanghai Golden Leaf MedTec Co. LtdAktiv, ikke rekrutterendeType 2 diabetes mellitus (T2DM)Kina
-
SanofiAfsluttet
-
Haisco Pharmaceutical Group Co., Ltd.AfsluttetT2DM (Type 2 Diabetes Mellitus)Kina
-
PegBio Co., Ltd.AfsluttetType 2 diabetes mellitus (T2DM)Kina
-
Oramed, Ltd.IntegriumAfsluttetT2DM (Type 2 Diabetes Mellitus)Forenede Stater
-
Oramed, Ltd.IntegriumAfsluttetT2DM (Type 2 Diabetes Mellitus)Forenede Stater
Kliniske forsøg med Modified DESMOND education and ongoing support
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Afsluttet
-
March of Dimes, CanadaHamilton Health Sciences CorporationAfsluttet
-
NYU Langone HealthAgency for Healthcare Research and Quality (AHRQ)Ikke rekrutterer endnuType 2 diabetesForenede Stater
-
Omada Health, Inc.Palo Alto Medical Foundation; Sutter HealthAfsluttetType 2 diabetesForenede Stater
-
University of MichiganNational Institute on Aging (NIA)Ikke rekrutterer endnuKronisk smerte | Kognitiv svækkelse
-
University of ArizonaRekruttering
-
University of ArkansasTrukket tilbageDiabetes mellitus, type 2 | SøvnhygiejneForenede Stater
-
University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Rekruttering
-
Omada Health, Inc.Abbott Diabetes Care; Evidation HealthAfsluttetType 2 diabetesForenede Stater
-
Psychiatric Research Unit, Region Zealand, DenmarkTrukket tilbagePsykiatrisk indlæggelse