Japan Diabetes Outcome Intervention Trial-1(J-DOIT1), a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment

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.

Effects of telephone-delivered lifestyle support on the development of diabetes in participants at high risk of type 2 diabetes: J-DOIT1, a pragmatic cluster randomised trial

“…The protocol, rationale and recruitment of the study participants are described elsewhere. 12 A cluster randomised controlled trial was conducted at healthcare divisions in companies and communities that carry out health check-ups for employees and residents. Randomisation occurred at the level of branches of the healthcare division to avoid contamination between the intervention and control arms.…”

“…The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a nationwide, pragmatic cluster randomised controlled trial. 11 12 The aim of this study was to investigate whether goal-focused lifestyle coaching delivered by telephone can effectively prevent the development of T2DM in high-risk individuals in a primary healthcare setting. We also aimed to clarify the effectiveness of telephone programmes for lifestyle support by comparing three different protocols.…”

Effect of antihyperglycemic drug monotherapy to prevent the progression of mild hyperglycemia in early type 2 diabetic patients: the Japan Early Diabetes Intervention Study (JEDIS)

“…In Japan, three large-scale clinical trials supported by the Ministry of Health, Labor and Welfare are underway, i.e., Diabetes Outcome Intervention Trial (DOIT)-1, 2 and 3, the underlying rationales of which are the primary, secondary and tertiary preventions of T2DM [29,30]. This study, Japan Early Diabetes Intervention Study (JEDIS), complements these DOITs by comparing the effect on hyperglycemia of standard education and care for diabetes, i.e., lifestyle interventions, to that of additional administration of AHAs in patients with T2DM at its early stage without any complication.…”

Diabetes prevention in the real world: Insights from the JDPP and J‐DOIT1

“…10 The Japan Diabetes Outcome intervention Trial-1 (J-DOIT1) is a nationwide, cluster randomized controlled trial, aiming to establish effective and efficient programs to prevent the development of T2D in high-risk individuals through lifestyle modifications. 11 This review will focus on the effectiveness of a diabetes prevention program (recruitment, target population, method of intervention, and evaluation) in the real world and insights from the JDPP and J-DOIT1. We will provide insights by answering a series of questions.…”

“…The Japan Diabetes Outcome intervention Trial‐1 (J‐DOIT1) is a nationwide, cluster randomized controlled trial, aiming to establish effective and efficient programs to prevent the development of T2D in high‐risk individuals through lifestyle modifications …”