NCT03211182

Lifestyle Modification Intervention in Pre-diabetic Subjects

Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The lifestyle intervention program focusing on healthy dietary habit and exercise effectively prevents progression to diabetes. Thus, the purpose of this study was to assess the effectiveness of lifestyle intervention program on pre-diabetics subjects in Taiwan.

Detailed description

The study is a 2-parallel groups' randomized controlled trial. Participants with elevated fasting plasma glucose concentrations (FPG 100-125 mg/dl) or glycated hemoglobin (HbA1C 5.7-6.3%) are enrolled. All study subjects are randomized to receive a lifestyle intervention (intervention group) or regular prevention education (control group). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (3th months, 6th months and 12th months). All participants complete a structured questionnaire, including basic information, disease history, physical activity, food-frequency, stage of change, and social support situation.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
BEHAVIORAL	lifestyle modification intervention	healthy lifestyle education and individualized counseling by well-trained case manager. The main goals of the lifestyle intervention included regular moderate intensity physical activity 150 min per week or more, and dietary strategies which reduce the risk of developing diabetes. The dietary suggestion was modified by Dietary Approaches to Stop Hypertension (DASH) Diet. Participants with BMI\>= 24 kg/m2 were encouraged to gradually lose weight at a rate of 0.5-1.0 kg per week until they achieved a BMI of 24 kg/m2.

Timeline

• Start date: 2012-03-07
• Primary completion: 2013-03-18
• Completion: 2018-12-31
• First posted: 2017-07-07
• Last updated: 2017-07-07

Locations

4 sites across 1 country: Taiwan