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Cited by 40Diabetes Management and EducationMobile Health and mHealth ApplicationsDiabetes, Cardiovascular Risks, and Lipoproteins

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 access
Sakane, Naoki, Kotani, Kazuhiko, Takahashi, Kaoru, Sano, Yoshiko, Tsuzaki, Kokoro, Okazaki, Kentaro, Sato, Juichi, Suzuki, Sadao +7 more·2015·BMJ Open
DOI 10.1136/bmjopen-2014-007316PMC PMC4550725
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Abstract

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)

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  • 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.

    “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 measured

  • Of 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)

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Cites

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Research works printed but not linked: 24

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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)
DOI
10.1136/bmjopen-2014-007316
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
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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