Abstract
BackgroundLifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach.The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects.MethodsFor the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards.ResultsForty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in individual characteristics between the study arms.ConclusionWe have launched J-DOIT1, a nation-wide trial to prevent the development of T2DM in high-risk individuals using telephone-delivered intervention. This trial is expected to contribute to evidence-based real-world preventive practices.Trial registrationUMIN000000662.
Highlights
Introduction and welcome callIn Week 1 In Month 2 Support callsIn Months 2, 3, 4, 7, and 10.In Months 3, 4, 5, 6, 7, 8, 9, In Months 7 and 12 10, and 11.Advice sheets by mail NoMonthly, during Month 2-12 Monthly, during Month 2-12Feedback by graph MonthlyThe number of groups in the control/ 8/8 intervention arm
A recent survey performed by the Ministry of Health, Labour and Welfare has projected that approximately 8.9 million people have diabetes and another 13.2 million people are at high risk for diabetes in Japan [3,4]
To what extent annual health checkups contribute toward overcoming the pandemic of diabetes
Summary
The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. In 2003 the Health Promotion Law was enforced aiming at preventing lifestyle-related diseases including T2DM It has become mandatory for all Japanese adults to undergo health checkups provided by public medical care insurance at least once a year. A large number of high-risk subjects for diabetes are identified every year through these health checkups. The Japan Diabetes Outcome intervention Trial-1 (J-DOIT1) is a nation-wide, cluster randomized controlled trial [17], aiming to establish effective and efficient programs to prevent the development of T2DM in high-risk individuals through lifestyle modifications. This information should be widely referred to and shared by researchers and practitioners in preventive medicine
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