Effects of lifestyle education program for type 2 diabetes patients in clinics: study design of a cluster randomized trial

Adachi, Misa; Yamaoka, Kazue; Watanabe, Miki; Nishikawa, Masako; Hida, Eisuke; Kobayashi, I; Tango, Toshiro

doi:10.1186/1471-2458-10-742

Cited by 20 publications

(32 citation statements)

References 17 publications

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“…A total of 12,018 persons with T2DM were included, of whom 5,893 were in the intervention group (IG) and 6,125 in the control group (CG), with an average age of 59.88 years (59.76 and 60, respectively). The mean baseline HbA 1 c was 7.83%, this value being the primary outcome in all cases (Adachi et al, ; Adolfsson, Walker‐Engström, Smide, & Wikblad, ; Clancy, Huang, Okonofua, Yeager, & Magruder, ; Davies et al, ; Deakin, Cade, Williams, & Greenwood, ; DePue et al, ; D'Eramo Melkus et al, ; Gregg, Callaghan, Hayes, & Glenn‐Lawson, ; Grillo et al, ; Hörnsten, Lundman, Stenlund, & Sandström, ; Houweling et al, ; Jutterström, Hörnsten, Sandström, Stenlund, & Isaksson, ; Khunti et al, ; Mash et al, ; Salinero‐Fort et al, ; Sönnichsen et al, ; Sturt et al, ; Thom et al, ; Wattana, Srisuphan, Pothiban, & Upchurch, ; Welch et al, ) except the Look AHEAD Study (Redmon et al, ), in which it was the weight loss achieved. The follow‐up periods ranged from 3–36 months, the most common being 12–14 months (13 studies).…”

Section: Resultsmentioning

confidence: 99%

“…Moreover, due to the inherent nature of these studies, there was no blinding of participants or programme providers. In over 75% of the studies, there was either a high risk of other biases being present or doubts in this respect, the most common such occurrences being the presence of recruitment bias in trials that were randomised by clusters (Adachi et al, ; Mash et al, ; Sönnichsen et al, ; Wattana et al, ) or the existence of contamination between participants in IG and CG (Sturt et al, ; Wattana et al, ). However, less than 25% of the studies presented a high risk of attrition or reporting bias (Figures and ).…”

Section: Resultsmentioning

confidence: 99%

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Impact of self‐care programmes in type 2 diabetes mellitus population in primary health care: Systematic review and meta‐analysis

Caro‐Bautista

Kaknani‐Uttumchandani

García‐Mayor

et al. 2020

Journal of Clinical Nursing

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Aims and Objectives: To evaluate the effectiveness of self-care programmes in type 2 diabetes mellitus (T2DM) population in primary health care. Background: The impact of educational interventions on T2DM has been evaluated in various contexts, but there is uncertainty about their impact in that of primary care. Design: Systematic review and meta-analysis. Methods: A search was conducted in PubMed, CINAHL, WOS and Cochrane databases for randomised controlled trials carried out in the period January 2005-December 2017, including studies with at least one face-to-face educational interventions. The quality of the evidence for the primary outcome was evaluated using the GRADE System. A meta-analysis was used to determine the effect achieved although only the results classified as critical or important were taken into consideration. Checklist of Preferred Reporting Items for Systematic Reviews and Meta-analyses has been followed. PROSPERO registration Number: CRD42016038833. Results: In total, 21 papers (20 studies) were analysed, representing a population of 12,018 persons with T2DM. For the primary outcome, HbA 1 c, the overall reduction obtained was −0.29%, decreasing the effect in long-term follow-up. The quality of the evidence was low/very low due to very serious risk of bias, inconsistency and indirectness of results. Better results were obtained for individual randomised trials versus cluster designs and in those programmes in which nurses leaded the interventions. The findings for other cardiovascular risk factors were inconsistent.Conclusions: Educational interventions in primary care addressing T2DM could be effective for metabolic control, but the low quality of the evidence and the lack of measurement of critical results generates uncertainty and highlights the need for high-quality trials.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Impact of self‐care programmes in type 2 diabetes mellitus population in primary health care: Systematic review and meta‐analysis

Caro‐Bautista

Kaknani‐Uttumchandani

García‐Mayor

et al. 2020

Journal of Clinical Nursing

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“…Details of the study design and calculation of the sample size were published previously [11], with only a brief description shown below. The study was approved by the Medical Ethical Committee of the National Institute of Public Health in Japan in 2006 (NO.…”

Section: Methodsmentioning

confidence: 99%

Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial

Adachi¹,

Yamaoka

Watanabe

et al. 2013

BMC Public Health

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BackgroundThe 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 (HbA1c) level in type 2 diabetes patients delivered by registered dietitians in primary care clinical settings.MethodsThis 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 HbA1c ≥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 HbA1c 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.ResultsThe mean change at 6 months from baseline in HbA1c 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.ConclusionsThe SILE program that was provided in primary care settings for patients with type 2 diabetes resulted in greater improvement in HbA1c levels than usual diabetes care and education.Trial registrationhttp://UMIN000004049

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“…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]. There is an urgent need for effective strategies to combat this pandemic.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2013

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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.

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Effects of lifestyle education program for type 2 diabetes patients in clinics: study design of a cluster randomized trial

Cited by 20 publications

References 17 publications

Impact of self‐care programmes in type 2 diabetes mellitus population in primary health care: Systematic review and meta‐analysis

Impact of self‐care programmes in type 2 diabetes mellitus population in primary health care: Systematic review and meta‐analysis

Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial

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

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