Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial
Open accessAbstract
Background: The prevalence of type 2 diabetes is rising worldwide, as has been the global mean fasting plasma glucose level. This study aimed to evaluate the effectiveness of a structured individual-based lifestyle education (SILE) program to reduce the hemoglobin A1c (HbA 1c) level in type 2 diabetes patients delivered by registered dietitians in primary care clinical settings. Methods: This was a 6-month prospective cluster randomized controlled trial in a primary care setting with randomization at the practice level. Twenty general practitioners in 20 clinics in Kanagawa prefecture, Japan, were involved. 193 adults (51% men, mean age 61.3 years) with type 2 diabetes and HbA 1c ≥6.5% who received treatment in medical clinics were the participants. A SILE program was implemented through 4 sessions with trained registered dietitians during the 6-month study period. Results were compared with those of a control group who received usual care. The primary endpoint was the change in HbA 1c levels at 6 months from baseline. Secondary endpoints were the changes at 6 months from baseline in fasting plasma glucose, lipid profile, blood pressure, BMI, energy, and nutrient intakes (whole day and each meal). Intention-to-treat analysis was conducted. Mixed-effects linear models were used to examine the effects of the treatment. Results: The mean change at 6 months from baseline in HbA 1c was a 0.7% decrease in the intervention group (n = 100) and a 0.2% decrease in the control group (n = 93) (difference −0.5%, 95%CI: -0.2% to −0.8%, p = 0.004). After adjusting for baseline values and other factors, the difference was still significant (p = 0.003 ~ 0.011). The intervention group had a significantly greater decrease in mean energy intake at dinner compared with the control group and a greater increase in mean vegetable intake for the whole day, breakfast, and lunch as shown in crude and adjusted models. A tendency toward improvement was observed in the other secondary endpoints but the improvement was not statistically significant. These results were confirmed by several sensitivity analyses. Conclusions: The SILE program that was provided in primary care settings for patients with type 2 diabetes resulted in greater improvement in HbA 1c levels than usual diabetes care and education. Trial registration: http://UMIN000004049
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Seventeen studies targeting diabetes reported mean changes in HbA1c, with seven reporting significant improvements in the intervention compared with usual care.
“Seventeen studies targeting diabetes reported mean changes in HbA1c, with seven reporting significant improvements in the intervention compared to usual care”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [50]
The Results (page unavailable) report a significant improvement in mean HbA1c change for the intervention group compared with the control group. This is one diabetes trial, however; the paper does not establish that 17 studies reported HbA1c changes or that seven found significant improvements. (LLM, conf=0.88)
Experimental — accuracy not yet measuredAdachi et al.'s T2DM intervention resulted in a 0.7% decrease in HbA1c at six months in the intervention group (n = 100) compared with a 0.2% decrease in the control group (n = 93) (difference −0.5%, 95% CI: -0.2%, −0.8%; p = 0.004).
“The intervention evaluated by Adachi et al. [50] for patients with T2DM resulted in a 0.7% decrease in HbA1c at six months in the intervention group (n = 100) compared with a 0.2% decrease in the control group (n = 93) (difference −0.5%, 95% CI: -0.2%, −0.8%; p = 0.004).”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [50]
Forty-four RCTs examined the impact of interventions on disease-specific outcomes.
“Forty four RCTs examined the impact of interventions on disease specific outcomes”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [50]
The Results section describes this paper’s single cluster-randomized trial, with 20 clinics randomized, but does not report a set of 44 RCTs. Searches for “forty four RCTs” and “44 randomized controlled trials” found no passage supporting the claimed count or its disease-specific-outcomes description. (LLM, conf=0.77)
Experimental — accuracy not yet measured
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- Authors
- Adachi, M., Yamaoka, K., Watanabe, M., Nishikawa, M., Kobayashi, I., Hida, E., & Tango, T.
- Affiliations
- Teikyo University (JP)
- Showa Women's University (JP)
- National Institute of Public Health (JP)
- Corresponding author
- Yamaoka, Kazue
- Venue
- BMC Public Health
- Published
- 2013-05-14
- Volume
- 13
- Issue
- 1
- Pages
- 467-467
- ISSN
- 1471-2458 (ISSN-L)
- PMC
- PMC3658890
- OpenAlex
- W2111023332
- Cited by
- 57
- References
- 41
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 1 · 2023: 4 · 2022: 4 · 2021: 7 · 2020: 2 · 2019: 3 · 2018: 6 · 2017: 9 · 2016: 7 · 2015: 7 · 2014: 1
- FWCI
- 3.94
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Public Health (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Ministry of Education, Culture, Sports, Science and Technology (2007-2008)
- Japan Society for the Promotion of Science (23500365, 23590831, 19500693)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- type 2 diabetes, lifestyle education, HbA1c, glycemic control, registered dietitians, primary care, dietary intervention, vegetable consumption, energy intake, lipid profile, blood pressure, body mass index, fasting blood glucose, usual care comparison, Japan, Kanagawa Prefecture, general practitioners, diabetes self-management
- MeSH terms
- Adult, Aged, Blood Glucose, Blood Pressure, Energy Intake, Diabetes Mellitus, Type 2, Female, Glucose Tolerance Test, Glycated Hemoglobin, Humans, Japan, Life Style, Male, Middle Aged, National Health Programs, Patient Education as Topic, Primary Health Care, Prospective Studies, Self Care, Body Mass Index, Cluster Analysis, Linear Models, Treatment Outcome, Control Groups, Young Adult
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