SLIMMER: a randomised controlled trial of diabetes prevention in Dutch primary health care: design and methods for process, effect, and economic evaluationReportar como inadecuado




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BMC Public Health

, 14:602

Chronic Disease epidemiology

Abstract

BackgroundImplementation of interventions in real-life settings requires a comprehensive evaluation approach. The aim of this article is to describe the evaluation design of the SLIMMER diabetes prevention intervention in a Dutch real-life setting.

Methods-DesignThe SLIMMER study is a randomised, controlled intervention study including subjects aged 40 through 70 years with impaired fasting glucose or high risk of diabetes. The 10-month SLIMMER intervention involves a dietary and physical activity intervention, including case management and a maintenance programme. The control group receives usual health care and written information about a healthy lifestyle. A logic model of change is composed to link intervention activities with intervention outcomes in a logical order. Primary outcome is fasting insulin. Measurements are performed at baseline and after 12 and 18 months and cover quality of life, cardio-metabolic risk factors e.g. glucose tolerance, serum lipids, body fatness, and blood pressure, eating and physical activity behaviour, and behavioural determinants. A process evaluation gives insight in how the intervention was delivered and received by participants and health care professionals. The economic evaluation consists of a cost-effectiveness analysis and a cost-utility analysis. Costs are assessed from both a societal and health care perspective.

DiscussionThis study is expected to provide insight in the effectiveness, including its cost-effectiveness, and delivery of the SLIMMER diabetes prevention intervention conducted in Dutch primary health care. Results of this study provide valuable information for primary health care professionals, researchers, and policy makers.

Trial registrationThe SLIMMER study is registered with ClinicalTrials.gov NCT02094911 since March 19, 2014.

KeywordsType 2 diabetes mellitus Prevention Combined lifestyle intervention Primary health care Real-life setting Evaluation design AbbreviationsAQuAAActivity Questionnaire for Adults and Adolescents

BMIBody mass index

CEACost-effectiveness analysis

CODAMCohort on diabetes and atherosclerosis maastricht

CUACost-utility analysis

FFQFood frequency questionnaire

GGD NOGGemeentelijke Gezondheidsdienst Noord- en Oost-Gelderland

GPGeneral practitioner

HbA1cGlycated hemoglobin

HDLHigh-density lipoprotein

ICERIncremental Cost-effectiveness ratio

IFGImpaired fasting glucose

LDLLow-density lipoprotein

OGTTOral glucose tolerance test

QALYQuality-adjusted life year

SF-36Short-form health survey

SLIMStudy on lifestyle intervention and impaired glucose tolerance Maastricht

SLIMMERSLIM iMplementation experience region Noord- en Oost-Gelderland

SQUASHShort questionnaire to assess health-enhancing physical activity

T0Baseline measurement

T1Measurement after 12 months

T2Measurement after 18 months

T2DMType 2 diabetes mellitus

WUWageningen University.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2458-14-602 contains supplementary material, which is available to authorized users.

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Autor: Geerke Duijzer - Annemien Haveman-Nies - Sophia C Jansen - Josien ter Beek - Gerrit J Hiddink - Edith JM Feskens

Fuente: https://link.springer.com/







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