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

Status and determinants of intra-household food allocation in rural Nepal.

BACKGROUND/OBJECTIVES: Understanding of the patterns and predictors of intra-household food allocation could enable nutrition programmes to better target nutritionally vulnerable individuals. This study aims to characterise the status and determinants of intra-household food and nutrient allocation in Nepal. SUBJECTS/METHODS: Pregnant women, their mothers-in-law and male household heads from Dhanusha and Mahottari districts in Nepal responded to 24-h dietary recalls, thrice repeated on non-consecutive days (n = 150 households; 1278 individual recalls). Intra-household inequity was measured using ratios between household members in food intakes (food shares); food-energy intake proportions ('food shares-to-energy shares', FS:ES); calorie-requirement proportions ('relative dietary energy adequacy ratios', RDEARs) and mean probability of adequacy for 11 micronutrients (MPA ratios). Hypothesised determinants were collected during the recalls, and their associations with the outcomes were tested using multivariable mixed-effects linear regression models. RESULTS: Women's diets (pregnant women and mothers-in-law) consisted of larger FS:ES of starchy foods, pulses, fruits and vegetables than male household heads, whereas men had larger FS:ES of animal-source foods. Pregnant women had the lowest MPA (37%) followed by their mothers-in-law (52%), and male household heads (57%). RDEARs between pregnant women and household heads were 31% higher (log-RDEAR coeff=0.27 (95% CI 0.12, 0.42), P < 0.001) when pregnant women earned more or the same as their spouse, and log-MPA ratios between pregnant women and mothers-in-law were positively associated with household-level calorie intakes (coeff=0.43 (0.23, 0.63), P < 0.001, per 1000 kcal). CONCLUSIONS: Pregnant women receive inequitably lower shares of food and nutrients, but this could be improved by increasing pregnant women's cash earnings and household food security