Effects of the Lifestyle Intervention Program GLICEMIA in People at Risk for Type 2 Diabetes: A Cluster-Randomized Controlled Trial

Abstract

OBJECTIVEThe aim of this study was to assess the efficacy of a 12-month prevention program conducted in 42 community pharmacies in reducing the risk for diabetes. RESEARCH DESIGN AND METHODSIn a cluster-randomized controlled trial in 1,092 participants, mean change in the risk for diabetes (indicated by the Finnish Diabetes Risk Score [FINDRISC]) between intervention and control groups was calculated. In the intervention program GLICEMIA, three appointments with individual counseling and five educational group sessions were combined, whereas in the control group, only information about the participants' health was obtained in three assessments. RESULTSAfter adjusting for cluster structure and differences in baseline characteristics, improvement in FINDRISC in the intervention group was 0.74 points (95% CI 0.42-1.04) above the control group. CONCLUSIONSThe GLICEMIA program shows the feasibility of a pharmacy-based intervention and leads to a significant modest reduction in diabetes risk score but does not reduce the rate of diabetes progression over 1 year.The prevalence of type 2 diabetes is increasing worldwide (1). As recently published in a meta-analysis, diabetes prevention in the outpatient setting can be effective (2). Community pharmacies could be a suitable site to establish a conveniently accessible diabetes prevention program (3,4). Therefore, the diabetes prevention program GLICEMIA was developed according to international guidelines and requirements of the German statutory health insurances (5-7). The aim of this study was to evaluate the feasibility and effectiveness of the diabetes prevention program GLICEMIA in community pharmacies. RESEARCH DESIGN AND METHODSThe trial is a prospective multicenter cluster-randomized controlled intervention study. The 42 participating community pharmacies in Bavaria, South Germany, were randomly assigned one-to-one to the intervention or to the control group. Pharmacists from each center participated in a 1-day training on how to conduct the study. The intervention pharmacies had an additional 0.5-day training on counseling for behavior changes. Thus, the study was not blinded. The trial started in

The Effectiveness and Cost of Lifestyle Interventions Including Nutrition Education for Diabetes Prevention: A Systematic Review and Meta-Analysis

“…15,24,25,34–99 Among included studies, there were 32 conducted in the US and 37 conducted in other countries. Study designs included RCT (n=41), pre-post (n=25), matched-cohort design (n=2), and non-randomized comparison (n=1).…”

Lifestyle precision medicine: the next generation in type 2 diabetes prevention?

“…Both protocols focused on overweight or obese (BMI > 25 kg/m 2 ) participants with impaired glucose regulation, and promoted a 5–7% weight reduction, a total and saturated fat intake reduction, an increase in fiber intake, and regular exercise. Numerous other trials focusing on lifestyle interventions in a range of ethnic groups and study settings followed [ 20 , 29 , 58 , 73 ], reporting reductions in diabetes incidence of comparable or lesser magnitude to the DPP and Finnish DPS trials. Long-term follow-up indicates that benefits of intensive lifestyle modification on diabetes incidence are sustained for up to 20 years [ 68 ].…”

FINDRISK im Praxistest

“…In einer cluster-randomisierten, kontrollierten Studie wurde untersucht, inwiefern es möglich ist, GLICEMIA in öf-fentlichen Apotheken umzusetzen und hierbei zu einer Reduktion wesentlicher Diabetesrisikofaktoren beizutragen [15]. Im vorliegenden Beitrag werden die Ergebnisse der Studie mit besonderem Augenmerk auf die einzelnen Aspekte des FINDRISK-Fragebogens diskutiert.…”