Effects of 'SPRAT' programme for dietary and lifestyle education to improve psychosomatic symptoms and dietary habits among adolescents: a cluster randomised controlled trial.

BACKGROUND: Dietary and lifestyle modifications to reduce subjective psychosomatic symptoms (SPS) have become an important topic worldwide. We developed a school-based dietary and lifestyle education programme that involved parents/guardians in reducing SPS in adolescents (SPRAT). The programme encouraged parents/guardians to participate in adolescents' healthy dietary and lifestyle modifications to reduce SPS, increase enjoyment of school life, and foster appropriate dietary intake. This study evaluated the effectiveness of SPRAT in reducing SPS and in altering dietary behaviour among adolescents. METHODS: A 6-month cluster randomised controlled trial using SPRAT and the usual school programme (control) was performed. Participants were middle school students in Japan who provided informed consent. Outcomes were SPS scores assessed at baseline and 2, 4, and 6 months after baseline and the proportions of dietary and lifestyle factors achieved such as enjoyment of school life and dietary intakes assessed by FFQW82. Change from baseline (CFB) at 6 months was the primary endpoint. A linear mixed-effects model was applied. As for dietary intake, the treatment effect was estimated as an interaction term between baseline and treatment "baseline*treatment". RESULTS: The intention-to treat analysis included 951 (94.7%) and 1035 (89.8%) individuals in the SPRAT and control groups, respectively. The CFB in the 6-month SPS score adjusted for baseline was lower in the SPRAT group (-0.29) than in the control group (0.62), but the difference was not statistically significant -0.91 (p = 0.093). CONCLUSIONS: Although the primary endpoint tended to denote improvement in the SPRAT group compared to the control group, the improvement was not significant. Favourable effects were observed in some secondary outcomes and statistically significant treatment*baseline interactions were observed for several dietary intakes. These results imply that CFBs of dietary intake were increased or decreased in a favourable direction depending on the baseline intake, especially in the SPRAT group. TRIAL REGISTRATION: UMIN000026715. (27/03/2017).

IgM monoclonal gammopathy with heavy-and-light-chain amyloidosis resembling fibrillary glomerulonephritis determined by tandem mass spectrometry: a case report.

BACKGROUND: Fibrillary glomerulonephritis (FGN) is distinguished from amyloidosis by thicker fibrils and the lack of staining with histochemical dyes typically reactive with amyloid. However, congophilic FGN has been proposed recently and adding laser microdissection followed by mass spectrometry (LMD/MS) to conventional pathological methods would be helpful to diagnose FGN. Here, we report a patient initially diagnosed with FGN whose final pathological diagnosis was changed to immunoglobulin heavy-and-light-chain amyloidosis (AHL) after LMD/MS. CASE PRESENTATION: A 75-year-old male developed nephrotic syndrome. Protein electrophoresis showed IgM κ type M proteinemia and he was diagnosed with IgM monoclonal gammopathy. A renal biopsy was performed and pathological examination showed marked periodic acid-Schiff-positive enlargement of the mesangial region and silver stain positivity, but weak direct fast scarlet staining. Immunofluorescence analysis showed monoclonal deposition of IgM-κ chain in the glomerulus. Under electron microscopy, the fibrils were about 20 nm in diameter, which was thicker than typical amyloid fibrils. Based on these findings, the patient was diagnosed with FGN. Although cyclophosphamide and prednisolone were administered, his renal function deteriorated and progressed to end stage renal disease requiring maintenance hemodialysis. As congophilic FGN has been recognized since 2018, Congo red staining and LMD/MS were performed. The Congo red staining was positive and LMD/MS results indicated that this was a case of AHL. CONCLUSIONS: We reported a case of µ and κ chain AHL resembling FGN requiring LMD/MS for definitive diagnosis. Since FGN and amyloidosis exhibit pathological findings, even if Congo red staining is positive, LMD/MS needs to be considered in cases atypical pathological findings, such as silver stain positivity or thicker fibrils.

School-based lifestyle education involving parents for reducing subjective psychosomatic symptoms in Japanese adolescents: study protocol for a cluster randomised controlled trial.

INTRODUCTION: Severe subjective psychosomatic symptoms (SPS) in adolescents are a major public health concern, and lifestyle modification interventions for reducing SPS are important topics. Recently, we developed a school-based lifestyle education involving parents for reducing SPS of adolescents (SPRAT), an improved version of the programme from our previous study Programme for adolescent of lifestyle education in Kumamoto (PADOK). This study aimed to evaluate the effectiveness of SPRAT in reducing SPS among adolescents. METHODS AND ANALYSIS: This is a 6-month, cluster randomised clinical trial with two intervention arms (SPRAT vs usual school education). The study population will be composed of middle school students (aged 12-14 years) with their parents/guardians in Japan. SPRAT is expected to be a more powerful programme than PADOK as it reinforces the role of parent participation. The primary endpoint will be the change from baseline SPS scores to those obtained after 6 months. Between-group differences will be analysed following the intention-to-treat principle. Crude and multivariate adjusted effects will be examined using a general linear mixed-effects model for continuous variables and a logistic regression model for dichotomous variables. The sample size required was determined based on the information needed to detect a difference in the primary outcome with a significance level of 5% and power of 80% under the assumptions of 40 students per cluster (assuming the same sample size for each cluster), an effect size of 0.3 and an intraclass correlation coefficient of 0.02. In total, participation by 28 schools (14 schools in each arm) (students: n=1120) will be needed. ETHICS AND DISSEMINATION: This study was approved by the Medical Ethical Committee of Minami Kyushu University in 2017 (number 137). The findings will be disseminated widely through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: UMIN000026715; Pre-results.

Does the behavioural type-specific approach for type 2 diabetes promote changes in lifestyle? Protocol of a cluster randomised trial in Japan.

INTRODUCTION: Type 2 diabetes (T2D) is a significant problem, and lifestyle modifications including self-management are important. We have developed a structured individual-based lifestyle education (SILE) programme for T2D. With attention now being paid to techniques to change behaviour, we recently developed a behavioural type-specific SILE (BETSILE) programme. We aimed to evaluate the effectiveness of the BETSILE programme compared with the SILE programme for reducing glycated haemoglobin (HbA1c) in patients with T2D and special behavioural types by a cluster randomised controlled trial. METHODS AND ANALYSIS: This is a 6-month cluster randomised controlled trial with two intervention arms (BETSILE vs SILE) provided in a medical care setting by randomising registered dietitians for patients with T2D aged 20-79 years. Patients' behavioural types were classified into four types (BT1 to BT4) using an assessment sheet. We will perform independent trials for BT1 and BT2. The primary endpoint is a change from the baseline HbA1c value at 6 months. Differences between the SILE and BETSILE groups will be primarily analysed following the intention-to-treat principle. Crude and multivariate adjusted effects will be examined after adjusting for covariates, using a general linear mixed-effects model for continuous variables and a logistic regression mixed-effects model for dichotomous variables. Sample sizes needed were calculated assuming effect sizes of 0.42 and 0.33 for BT1 and BT2, respectively, an intraclass correlation of 0.02, a significance level of 5% (two-sided), a power of 80%, and equal allocation of clusters to the two arms, with each cluster having three BT1 patients for the SILE and BETSILE arms and six BT2 patients for the SILE and BETSILE arms. We will need 16 dietitians for each arm, and a total 288 patients will be required. ETHICS AND DISSEMINATION: This study has been approved by the Medical Ethical Committee of Teikyo University (No.15-222). Findings will be disseminated widely through peer-reviewed publications, etc. TRIAL REGISTRATION NUMBER: UMIN 000023087; Pre-results.

Effects of a lifestyle modification programme to reduce the number of risk factors for metabolic syndrome: a randomised controlled trial.

OBJECTIVE: To determine the effectiveness of a personal support lifestyle education programme (PSMetS) for reducing risk factors in individuals with metabolic syndrome (MetS). DESIGN: A two-arm randomised controlled trial. SETTING: Companies in metropolitan Tokyo, Japan. SUBJECTS: Male workers with diagnosed MetS or a high risk for MetS according to the Counselling Guidance Program, Japan (n 193). RESULTS: The reduction in the number of risk factors for MetS (as defined according to the criteria published by the Japanese Ministry of Health, Labor and Welfare in April 2007 (MHLW-MetS)) in the PSMetS group was not significantly different from that in the usual care group by van Elteren's test (baseline-adjusted P=0·075) for intention-to-treat (ITT), while it was significant (baseline-adjusted P=0·038) for per-protocol set (PPS). The proportion of MHLW-MetS was significantly different between groups by van Elteren's test (baseline-adjusted P=0·031). Two components of MHLW-MetS showed significant reductions in the PSMetS group: waist circumference (baseline-adjusted P=0·001) and BMI (baseline-adjusted P=0·002). PPS and ITT analyses showed similar results. CONCLUSIONS: For male workers with MHLW-MetS or a high risk of MHLW-MetS, PSMetS reduced the number of risk factors for MHLW-MetS.

Effect of School-Based Home-Collaborative Lifestyle Education on Reducing Subjective Psychosomatic Symptoms in Adolescents: A Cluster Randomised Controlled Trial.

In this study, we aimed to assess the effectiveness of a school-based home-collaborative lifestyle education program for adolescents (PADOK) in reducing poor subjective psychosomatic symptoms (SPS). The study was designed as a two-armed parallel cluster randomised controlled trial and the study population comprised adolescent students (aged 12-14 years, n = 1,565) who were recruited from 19 middle schools in Japan. The PADOK intervention or usual school programme was provided in schools to all eligible participants. The primary outcome was the SPS score at 6 months, while secondary outcomes included lifestyle factors, BMI, and dietary intakes. Analyses were undertaken on an intention to treat (ITT) basis accounting for the clustered design. Nineteen schools were randomised to the PADOK group (10 schools) and control group (9 schools). The numbers of students used for analysis were 1,509 for ITT and 1,420 (94.1%) for PPS. At 6 months, the crude mean change from baseline of the SPS scores by ITT analysis showed a significantly greater reduction in the PADOK group compared to that in the control group (-0.95, 95% CI -1.70 to -0.20, P = 0.016), while those for baseline-adjusted and multivariate-adjusted values showed similar directionality but were not significant (P = 0.063 and P = 0.130). The results indicated that the PADOK program may improve poor SPS scores among adolescents.

[The association between subjective symptoms and lifestyle habits among junior high school students a cross-sectional survey in Kumamoto, Japan].

OBJECTIVES: This study aimed to examine the association between subjective symptoms and lifestyle habits among junior high school students by using a cross-sectional survey. METHODS: The survey was conducted during May-November 2012. The study subjects were 1229 adolescents (527 boys and 702 girls, age 12-13 years) from 10 junior high schools in Kumamoto Prefecture, Japan. Data from 1182 students (500 boys and 682 girls; response rate 96.2%) were used for the analyses. School nurses measured students' body weights and heights. A self-administered questionnaire examining dietary intake (FFQW82), subjective symptoms (12 items), lifestyle habits (18 items), and diet- and health-related topics (9 items) was used. The 4 categories of each of the 12 subjective symptoms were classified into dichotomous variables (1=always or sometimes; 0=occasionally or never). The subjective symptom score was calculated as a total score by summing up the dichotomous variables for the 12 subjective symptoms. Associations were examined using a chi-square test, Student's t-test, Wilcoxon rank sum test, and a stepwise regression model. The structure of factors was examined by factor analysis (varimax rotation) and associations among the question items were examined by principal component analysis. A significance level of 5% (two-sided) was applied and SAS ver. 9.3 software was used for the analyses. RESULTS: Students' body weights and heights were mostly at or near national averages. The ratio of energy intake at breakfast, lunch, and dinner for the 1-day total energy intake (kcal) was respectively 2:3:4, indicating decreased energy intake at breakfast. The percent energy (%E) from fat of the 1-day total energy intake was 29%E for boys and 30%E for girls. Using regression models, we found that the following lifestyle factors were significantly related to fewer subjective symptoms: "balanced diet," and "sleeping 6 hours or more per day" were for boys and girls, "regularly eating three meals a day," "strong appetite," and "having relaxation time" for girls. However, the following factors were significantly related to more subjective symptoms: "eating hurriedly," and "2 hours or more of watching television or playing video games" were for boys and girls, "cooking meals or sweets" for boys, "eating snacks and nighttime meals," and "eating dinner after 9 p.m.," and "preparing bento (boxed lunches)" for girls. Dietary intake was not significantly related to subjective symptoms. CONCLUSION: Findings from this study suggest that subjective symptoms are associated with lifestyle habits among junior high school students.

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

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 (HbA1c) 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 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. RESULTS: The 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. CONCLUSIONS: The 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 REGISTRATION: http://UMIN000004049.

Validity and reproducibility of the FFQ (FFQW82) for dietary assessment in female adolescents.

OBJECTIVE: To assess the validity and reproducibility of a self-administered FFQ with eighty-two food items (FFQW82) for assessing the habitual diet in female adolescents. DESIGN: The validity of the FFQW82 for assessment of nutrient intake was evaluated by comparison with a 7 d weighed food record (7d-FRRI) reported as 'gold standard'. Reproducibility of the FFQW82 was assessed at an interval of 1 month (test-retest method). The first survey (FFQW82 and 7d-FRRI) was conducted in April 2007 and the second FFQW82 survey was conducted in May 2007. Daily consumption of energy from eleven food groups and nine nutrients were calculated from both instruments for breakfast, lunch, dinner and the whole day. Crude and energy-adjusted Pearson correlation coefficients were calculated using log-transformed data. SETTING: Middle school, Tokyo, Japan. SUBJECTS: Female adolescents aged 12-13 years. RESULTS: Sixty-three female adolescents completed both surveys. The relative difference between the energy intake calculated by the FFQW82 and the 7d-FRRI for the whole day, breakfast, lunch and dinner was 8 %, 10 %, 15 % and 10 %, respectively. As for validity, the correlation coefficient of total energy intake for the whole day was 0·31. The result for breakfast was relatively higher (0·59) compared with that for lunch (0·40) and dinner (0·32). For macronutrients, the energy-adjusted correlation coefficient ranged from 0·28 (carbohydrates) to 0·53 (protein). Reproducibility of total energy intake was 0·62 and ranged from 0·46 (fat) to 0·69 (carbohydrate) for macronutrients. CONCLUSIONS: These results suggest that the FFQW82 has proved to have some potential with regard to reproducibility among our study population.

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

BACKGROUND: The number of patients with type 2 diabetes is drastically increasing worldwide. It is a serious health problem in Japan as well. Lifestyle interventions can reduce progression from impaired glucose tolerance to type 2 diabetes, and glycemic control has been shown to improve postprandial plasma glucose levels. Moreover, several studies have suggested that continuous interventions (combined diet and exercise) can improve the plasma glucose level and reduce dosage of hypoglycemic agents.Although many interventional studies of lifestyle education for persons with diabetes in hospitals have been reported, only a few have been clinic-based studies employing an evidence-based lifestyle education program. This article describes the design of a cluster randomized controlled trial of the effectiveness of lifestyle education for patients with type 2 diabetes in clinics by registered dietitians. METHODS/DESIGN: In Japan, general practitioners generally have their own medical clinics to provide medical care for outpatients in the community, including those with type 2 diabetes. With the collaboration of such general practitioners, the study patients were enrolled in the present study. Twenty general practitioners were randomly allocated to each provide patients for entry into either an intervention group (10) or a control group (10). In total, 200 participants will be included in the study. The intervention group will receive intensive education on lifestyle improvement related to type 2 diabetes by registered dietitians in clinics. Lifestyle education will be conducted several times during the study period. The control group will receive information on dietary intake and standard advice on glycemic control by registered dietitians. The primary endpoint is the change from the baseline value of HbA1c at 6 months. Data on health behavior and related issues will be gathered continuously over a 6-month period. DISCUSSION: This is the first study to evaluate lifestyle education in clinics by a cluster randomization trial in Japan. The proposed study will provide practical information about the usefulness of the intensive lifestyle improvement education program in primary care settings. The study was started in September 2007 and entry of subjects was completed in December 2010. Data on the effect evaluation will be available in 2011. TRIAL REGISTRATION: UMIN000004049.

[Validity and reproducibility of a food frequency questionnaire with 82-food items (FFQW82) for nutrition education].

OBJECTIVE: To assess the validity and reproducibility of a food frequency questionnaire with 82-food items (FFQW82) for nutrition education to modify eating habits. METHODS: The validity of nutrient intake assessed by FFQW82 was evaluated with seven-day diet records (7d-DR) as the gold standard, with questionnaire being administered twice with a one month interval to assess reproducibility. Twenty nine men (ages 42-63) and sixty women (ages 35-53) completed both surveys. Daily consumption of energy for 12 food groups and 9 nutrients was calculated from the FFQW82 and the 7d-DR with respect to breakfast, lunch, dinner, and whole-day meals. A Pearson correlation coefficient was obtained for each using log-transformed data. RESULTS: The estimated energy intakes from FFQW82 were higher than those from 7d-DR for men and women (relative differences of the median were 7% and 15%, respectively). As for validity, Pearson correlation coefficients of total energy intakes were 0.61 for men and 0.47 for women. Those for breakfast and lunch ranged from 0.66 to 0.89, while those for dinner were 0.19 and 0.26 for men and women. The daily intakes of nine nutrients ranged from 0.28 (potassium) to 0.65 (carbohydrate) in men and from 0.39 (fat) to 0.59 (calcium) in women. Regarding reproducibility, Pearson correlation coefficients for whole-day total energy intake were 0.65 for men and 0.69 for women. Those for the other nutrients ranged from 0.46 (salt) to 0.70 (carbohydrate) in men and from 0.59 (fat) to 0.70 (salt) in women. CONCLUSION: The results suggest that FFQW82 could be used as a tool to obtain information concerning unbalance energy intake with reference to individual meals and to understand appropriate intake of the various food groups for nutrition education of middle-aged men and women.