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
Open accessAbstract
Objectives: To examine the effects of telephone-delivered lifestyle coaching on preventing the development of type 2 diabetes mellitus (T2DM) in participants with impaired fasting glucose (IFG). Design: Cluster randomised trial. Setting: 40 groups from 17 healthcare divisions in Japan: companies (31), communities (6) and mixed settings (3). Participants: Participants aged 20–65 years with fasting plasma glucose (FPG) of 5.6–6.9 mmol/L were invited from the 17 healthcare divisions. Randomisation: The groups were then randomly assigned to an intervention or a control arm by independent statisticians according to a computer-generated list. Intervention: The intervention arm received a 1-year telephone-delivered intervention provided by three private lifestyle support centres (at different frequencies: low-frequency (3 times), middle-frequency (6 times) and high-frequency (10 times) support calls). The intervention and control arms both received self-help devices such as a weight scale and pedometer. Outcomes: Participants were followed up using data from annual health check-ups and a questionnaire regarding lifestyle. The primary outcome was the development of T2DM defined as FPG ≥7.0 mmol/L, the diagnosis of diabetes, or use of an antidiabetic drug, confirmed by referring to medical cards. Results: Of 14 473 screened individuals, participants were enrolled in either the intervention (n=1240) arm or control (n=1367) arm. Overall, the HR for the development of T2DM in the intervention arm during 5.5 years was 1.00 (95% CI 0.74 to 1.34). In the subanalysis, the HR was 0.59 (95% CI 0.42 to 0.83) in the subgroup that received phone calls the most frequently, compared with the control arm. A limitation of the study includes a lack of blinding. Conclusions: High-frequency telephone-delivered lifestyle support could effectively prevent T2DM in participants with IFG in a primary healthcare setting, although low-frequency and middle-frequency phone calls did not. Trial registration number: This trial has been registered with the University Hospital Medical Information Network (UMIN000000662).
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Of 5 TM studies on T2DM development, 1 by Sakane et al indicated TM is effective, and the other 4 did not show significant differences compared to the control group.
“Of the 5 (20%) studies reporting the effects of TM on T2DM development, only 1 (20%) study by Sakane et al [39] indicated that TM is effective. The other 4 (80%) studies [35,40,44,50] did not show any significant differences compared to the control group.”
From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [39]
The Results (Primary outcomes; page unavailable) report no reduction in T2DM development overall: HR 1.00 (95% CI 0.74–1.34). The Discussion (Main findings; page unavailable) explicitly says the study could not prove the intervention effective overall. A significant reduction appeared only in the subgroup at the centre providing 10 telephone calls, so describing the study without that qualification as showing TM was effective contradicts its overall finding. (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredAll studies successful in improving dysglycemia had a DHI duration of at least 3 months, while the study successful in T2DM prevention had a duration of 12 months.
“All studies successful in improving dysglycemia had a DHI duration of at least 3 months, while the study successful in T2DM prevention had a duration of 12 months [39].”
From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [39]
The Methods (Intervention arm; page unavailable) describe telephone support over one year, and the Results (Primary outcomes; page unavailable) report significantly lower T2DM incidence for the high-frequency centre C subgroup. The trial found no overall reduction in T2DM incidence, however, so calling the study successful without that qualification overstates its findings. This single trial also does not establish that all studies improving dysglycemia lasted at least three months. (LLM, conf=0.88)
Experimental — accuracy not yet measuredOf 5 PHT studies on T2DM prevention, 1 (20%) posted a positive effect and 4 (80%) reported a neutral effect.
“Of the 5 (13.5%) studies on PHT reporting its effects on preventing T2DM, 1 (20%) study [39] posted a positive effect, with 4 (80%) other studies [35,36,40,41] reporting a neutral effect on T2DM development.”
From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [39]
TM effects on consumer experience were varied: 5 (71.4%) studies reported positive effects, 1 (14.2%) no discernible effect, and 1 (14.2%) mixed effects.
“The effects of TM on consumer experience were varied, with 5 (71.4%) studies [39,44,48,53,54] reporting positive effects, 1 (14.2%) study [5] with no discernible effect, and 1 (14.2%) study [55] with mixed effects.”
From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [39]
Citation [5] is attached to the claim that this study found no discernible effect on consumer experience, not to the seven-study tally. The Results (‘Adherence and satisfaction’; page unavailable) report participant satisfaction scores across three support centres, but do not report an intervention-versus-control effect on consumer experience. The Results (‘Primary outcomes’; page unavailable) report no overall effect on diabetes incidence, which is a different outcome. (LLM, conf=0.72)
Experimental — accuracy not yet measured
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Cites
Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin
(2002) · New England Journal of Medicine · doi:10.1056/nejmoa012512 · Cited by 19,011 · see citing works
Tuomilehto, J., Lindström, J., Eriksson, J. G., Valle, T. T., Hämäläinen, H., Ilanne-Parikka, P., Keinänen-Kiukaanniemi, S., Laakso, M., Louheranta, A., Rastas, M., et al. (2001) · New England Journal of Medicine · doi:10.1056/nejm200105033441801 · Cited by 10,873 · see citing works
Global variability in fruit and vegetable consumption
Hall, J. N., Moore, S., Harper, S. B., & Lynch, J. W. (2009) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2009.01.029 · Cited by 597 · see citing works
Cardona-Morrell, M., Rychetnik, L., Morrell, S. L., Espinel, P. T., & Bauman, A. (2010) · BMC Public Health · doi:10.1186/1471-2458-10-653 · Cited by 147 · see citing works
Blackberry, I. D., Furler, J. S., Best, J. D., Chondros, P., Vale, M., Walker, C., Dunning, T., Segal, L., Dunbar, J., Audehm, R., et al. (2013) · BMJ · doi:10.1136/bmj.f5272 · Cited by 113 · see citing works
Balion, C. M., Raina, P. S., Gerstein, H. C., Santaguida, P. L., Morrison, K. M., Booker, L., & Hunt, D. L. (2007) · Clinical Chemical Laboratory Medicine · doi:10.1515/cclm.2007.505 · Cited by 107 · cited 1× · see citing works
“Because of poor reproducibility, we must be careful when interpreting a single test result.(29) In addition, we may have missed diabetic and IGT participants with normal fasting but elevated 2 h plasma glucose levels.”
Method
Flagged first, then by citations
Research works printed but not linked: 24
- [1]Danaei G, Finucane MM, Lu Y; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose). National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2·7 million participants. Lancet 2011; 378: 31– 40. 10.1016/S0140-6736(11)60679-X 21705069 · DOI · Paper page
- [2]Neville SE, Boye KS, Montgomery WS Diabetes in Japan: a review of disease burden and approaches to treatment. Diabetes Metab Res Rev 2009; 25: 705– 16. 10.1002/dmrr.1012 19795421 · DOI
- [6]Nakashima N, Kobayashi K, Inoguchi T A Japanese model of disease management. Stud Health Technol Inform 2007; 129 (Pt 2): 1174– 8. 17911900
- [7]Fukuda Y Quasi-experimental study of effects of “healthcare advice with particular focus on metabolic syndrome”. Nihon Eiseigaku Zasshi 2011; 66: 736– 40. 10.1265/jjh.66.736 21996775 · DOI
- [9]Appel LJ, Clark JM, Yeh HC Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med 2011; 24: 1959– 68. 10.1056/NEJMoa1108660 PMC4074540 22085317 · DOI · Paper page
- [10]Digenio AG, Mancuso JP, Gerber RA Comparison of methods for delivering a lifestyle modification program for obese patients: a randomized trial. Ann Intern Med 2009; 150: 255– 62. 10.7326/0003-4819-150-4-200902170-00006 19221377 · DOI · Paper page
- [11]Yazaki Y, Kadowaki T Combating diabetes and obesity in Japan. Nat Med 2006; 12: 73– 4. 10.1038/nm0106-73 16397574 · DOI
- [12]Sakane N, Kotani K, Takahashi K 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. BMC Public Health 2013; 13: 81 10.1186/1471-2458-13-81 23356246 PMC3579679 · DOI
- [13]Kuzuya T, Nakagawa S, Satoh J; Committee of the Japan Diabetes Society on the diagnostic criteria of diabetes mellitus. Report of the Committee on the classification and diagnostic criteria of diabetes mellitus. Diabetes Res Clin Pract 2002; 55: 65– 85. 10.1016/S0168-8227(01)00365-5 11755481 · DOI
- [14]Tudor-Locke C, Hatano Y, Pangrazi RP How many steps/day are enough? For adults. Int J Behav Nutr Phys Act 2011; 8: 79 10.1186/1479-5868-8-79 21798015 PMC3197470 · DOI · Paper page
- [15]Saito T, Watanabe M, Nishida J Lifestyle modification and prevention of type 2 diabetes in overweight Japanese with impaired fasting glucose levels: a randomized controlled trial. Arch Intern Med 2011; 171: 1352– 60. 10.1001/archinternmed.2011.275 21824948 · DOI · Paper page
- [17]Lin Y, Kikuchi S, Tamakoshi A Alcohol consumption and mortality among middle-aged and elderly Japanese men and women. Ann Epidemiol 2005; 15: 590– 7. 10.1016/j.annepidem.2004.10.010 16118003 · DOI
- [18]Anuurad E, Shiwaku K, Nogi A The new BMI criteria for Asians by the regional office for the western pacific region of WHO are suitable for screening of overweight to prevent metabolic syndrome in elder Japanese workers. J Occup Health 2003; 45: 335– 43. 10.1539/joh.45.335 14676412 · DOI
- [19]Pan WH, Yeh WT How to define obesity? Evidence-based multiple action points for public awareness, screening, and treatment: an extension of Asian-Pacific recommendations. Asia Pac J Clin Nutr 2008; 17: 370– 4. 18818155
- [20]Mieno MN, Yamaguchi T, Ohashi Y Alternative statistical methods for estimating efficacy of interferon beta-1b for multiple sclerosis clinical trials. BMC Med Res Methodol 2011; 11: 80 10.1186/1471-2288-11-80 21612661 PMC3118202 · DOI
- [21]Ito C, Maeda R, Nakamura K Prediction of diabetes mellitus (NIDDM). Diabetes Res Clin Pract 1996; 34: S7– 11. 10.1016/S0168-8227(96)90002-9 9015664 · DOI
- [22]Funatogawa I, Funatogawa T, Nakao M Changes in body mass index by birth cohort in Japanese adults: results from the National Nutrition Survey of Japan 1956–2005. Int J Epidemiol 2009; 38: 83– 92. 10.1093/ije/dyn182 18782894 PMC2639362 · DOI
- [23]Sakane N, Sato J, Tsushita K Prevention of type 2 diabetes in a primary healthcare setting: three-year results of lifestyle intervention in Japanese subjects with impaired glucose tolerance. BMC Public Health 2011; 11: 40 10.1186/1471-2458-11-40 21235825 PMC3037863 · DOI
- [24]Weinstock RS, Trief PM, Cibula D Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE study. J Gen Intern Med 2013; 28: 1620– 8. 10.1007/s11606-013-2529-7 23843020 PMC3832730 · DOI
- [25]Ma J, Yank V, Xiao L Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. JAMA Intern Med 2013; 173: 113– 21. 10.1001/2013.jamainternmed.987 23229846 PMC3856315 · DOI
- [26]Hesselink AE, Bilo HJ, Jonkers R A cluster-randomized controlled trial to study the effectiveness of a protocol-based lifestyle program to prevent type 2 diabetes in people with impaired fasting glucose. BMC Fam Pract 2013; 14: 184 10.1186/1471-2296-14-184 24295397 PMC4219396 · DOI
- [27]Sanchez A, Silvestre C, Sauto R Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial. BMC Fam Pract 2012; 13: 109 10.1186/1471-2296-13-109 23158830 PMC3538670 · DOI
- [28]Johnson M, Jones R, Freeman C Can diabetes prevention programmes be translated effectively into real-world settings and still deliver improved outcomes? A synthesis of evidence. Diabet Med 2013; 30: 3– 15. 10.1111/dme.12018 22998334 PMC3555428 · DOI
- [30]Bartoli E, Fra GP, Carnevale Schianca GP The oral glucose tolerance test (OGTT) revisited. Eur J Intern Med 2011; 22: 8– 12. 10.1016/j.ejim.2010.07.008 21238885 · DOI
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- Authors
- Sakane, N., Kotani, K., Takahashi, K., Sano, Y., Tsuzaki, K., Okazaki, K., Sato, J., Suzuki, S., Morita, S., Oshima, Y., Izumi, K., Kato, M., Ishizuka, N., Noda, M., & Kuzuya, H.
- Affiliations
- Kyoto Medical Center (JP)
- Jichi Medical University (JP)
- Nagoya University (JP)
- Nagoya City University (JP)
- Kyoto University (JP)
- University of Marketing and Distribution Sciences (JP)
- National Center for Global Health and Medicine (JP)
- The Cancer Institute Hospital (JP)
- Corresponding author
- Sakane, Naoki
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2015-08
- Volume
- 5
- Issue
- 8
- Pages
- e007316
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC4550725
- OpenAlex
- W2109672764
- Cited by
- 40
- References
- 6
- Citations by year
- 2026: 2 · 2025: 6 · 2023: 5 · 2022: 2 · 2021: 7 · 2020: 6 · 2019: 4 · 2018: 3 · 2017: 2 · 2016: 3
- FWCI
- 2.32
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Institutional Repositories DataBase (IRDB) (submittedVersion, cc-by-nc)
- Kyoto University Research Information Repository (Kyoto University) (submittedVersion, cc-by-nc)
- Funders
- Ministry of Health, Labour and Welfare
- JFE Steel Corporation
- Japan Society for the Promotion of Science (15K08580)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- type 2 diabetes prevention, impaired fasting glucose, lifestyle support, primary care, workplace health promotion, self-help devices, pedometers
- MeSH terms
- Adult, Blood Glucose, Cost-Benefit Analysis, Counseling, Diabetes Mellitus, Type 2, Female, Health Promotion, Health Services, Humans, Japan, Life Style, Male, Middle Aged, Prediabetic State, Primary Health Care, Risk, Telephone, Health Behavior
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