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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p>UMIN000004049</p

都市部女子中高生の食育課題の検討 : 食意識・食行動・食環境,食事調査分析結果

OBJECTIVE: In this study we investigated dietary consciousness, dietary behavior, dietary environment and dietary intake in Japanese urban schoolgirls and their mothers, and examined some useful indicators for their dietary education. METHODS: The survey was conducted during Sept 2005. Participants: The subjects were 262 junior high school girls (age 12-13yrs) and 240 mothers, 145 senior high school girls (age 15-16yrs) and 90 mothers, total subjects were 737. OUTCOME: 1. The questionnaire asked about their weight perception, eating behavior, environment, habits, and health condition in 76 questions. 2. Energy intake was assessed by 2 day dietary record method. 3. Age, height and body weight were measured by a teacher. Those with a tendency towards obesity were ≧120, and those underweight were ≦80%, based on the baseline degree of obesity by the Ministry of Education. A TANITA scale was used and BMI was calculated based on the degree of obesity in the Japanese Obesity Association. RESULTS: 1. Significant correlation coefficients were obtained between the body type classification and the degree of obesity, (junior high school girls: p<0.001, senior high school girls: p<0.001). Many schoolgirls perceived themselves overweight notwithstanding that weights were at an appropriate level. 2. Significant correlation coefficients were obtained between the self-rated energy intakes and the degree of obesity, (junior high school girls: p<0.001, senior high school girls: p<0.01). 3. Energy intakes by 2day dietary record method were not enough compared to their EER (estimated energy requirement), junior high school girls: 1685±410kcal, senior high school girls: 1670±433kcal. Micronutrient intake of Ca, Fe, VC and dietary fiber were less than DG (tentative dietary goal), but the ratio of fat energy was over the UL (tolerable upper intake level), junior high school girls: 32.5%, senior high school girls: 34.6%. 4. Energy intake of the mothers significantly correlated with that of their children in evening meals (breakfast: r=0.23, lunch: r=0.21, evening: r=0.35, total intake: r=0.25). 5. Correlation of between-item by Theory of quantification III showed 2 patterns. One correlated to the healthy dietary behavior, perception and environment, the other one had contradictory pattern that correlated to "overeat", "overweight" and "dieting practice" (η^2=0.13). DISCUSSION: In this study we describe probable associations which may provide an understanding of some aspects of nutrition education for Japanese urban schoolgirls

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

A Case of Trousseau’s Syndrome Accompanying Ovarian Cancer with Widespread Thromboembolisms

The patient was a 41-year-old woman, gravida 0. She had no notable medical history. Laparoscopic right salpingo-oophorectomy and left cystectomy were performed for bilateral ovarian endometriomas, which were both pathologically diagnosed as benign. Six months later, she presented with left lower abdominal pain and expressive aphasia. Examination revealed multiple cerebral infarctions and pulmonary embolism. The patient was diagnosed with Trousseau’s syndrome secondary to ovarian cancer, and anticoagulant therapy was initiated. Despite treatment, she developed visual field loss due to occlusion of the left retinal artery; dizziness due to cerebellar infarction and myocardial infarction; and right hemiplegia due to new cerebral infarction. She received chemotherapy (two courses of paclitaxel and carboplatin), which did not improve her condition, and died two months after onset. An autopsy revealed that her left ovary was enlarged to a size of 12 cm and an endometrioid carcinoma G2 was identified. Ovarian cancer had spread throughout the abdominal cavity, and a large amount of pleural and ascites fluid was present. Multiple thrombi were found in bilateral pulmonary arteries and bilateral common iliac veins. There was a 2.5 cm thrombus in the left ventricle apex, and the anterior descending branch was obstructed by thrombus with recanalization