The randomized trial about the efficacy of a 2-Day in-Hospital Diabetes Educational Program for prevention of type 2 diabetes (The JOETSU Diabetes Prevention Trial)

UMIN ID: UMIN000000911

Registered date:29/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Impared Glucose Tolerance
• Date of first enrollment: 2003/06/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

In the STH (Short Term Hospitalization) group, participants took a 9-lesson curriculum, designed as a clinical course, covering special diet, exercise, and behavior modification to help them change their behavior. Each curriculum, instructed by case managers, dietitians, pharmacists, physical therapists, nurses, and physicians on a one-to-one or group basis, was flexible, culturally sensitive, and individualized. We set the diet at 25-30 kcal/kg of ideal body weight in each case, and the goal of dietary intervention was a total daily intake of fat that was less than 20-25 percent of daily energy intake. In addition, participants received exercise therapy in the form of participation in a traditional Japanese physical exercise radiobroadcast program. We instructed the participants to continue walking or doing the radiobroadcast physical exercise for at least 30 minutes per day, more than 5 times a week after discharge from hospital. Subsequent individual sessions every 3 months with the case managers or dietitians, designed to reinforce the behavioral changes, were similar to the program received by members of the DES group.
In the DES (Diabetes Education and Support) group, participants were provided with written information and periodical 20 to 30 min individual sessions that emphasized the importance of a healthy lifestyle. Participants were encouraged to follow the diabetes guidebook (Diabetes Treatment Guidebook 2003) issued by the Japan Diabetes Society. They were also instructed to follow the equivalent of the food guidebook (Food Nutrition Database for Diabetes Diet Therapy, version 6, 2002, Japan Diabetes Society) to reduce their weight, and to increase their physical activity.
In the CONT (Control) group, participants were given general information about diabetes and impaired glucose tolerance. Their physician also provided diabetes information brochures with general instructions for diet and improvement of lifestyle, but no individual instruction or formal group counseling sessions were conducted.

Outcome(s)

• Primary Outcome: All participants were seen at 3-month intervals by their physicians. Blood and urine samples were taken for examination. We estimated the incidence of type 2 diabetes.
• Secondary Outcome: All participants were seen at 3-month intervals by their physicians. Body weight, waist circumference, and blood pressure were measured. We estimated the efficay of our program for changes in serum lipids, body weight, and blood pressure

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: We exclude patients who were diabetes, hypertension, or hyperlipidemia with taking any medication which might affect glycemic control.

Related Information

• Primary Sponsor: Niigata-Rousai Hospital, Joetsu, Japan
• Source(s) of Monetary Support: Niigata-Rousai Hospital, Joetsu, Japan