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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
300
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.
YUANH
Kaohsiung City, Lingya Dist, Taiwan
ACTIVE_NOT_RECRUITINGSKH
Taipei, Shilin Dist., Taiwan
RECRUITINGTMUH
Taipei, Sinyi District,, Taiwan
RECRUITINGblood sugar
changes in fasting glucose and glycated hemoglobin
Time frame: 3 month, 6 month and 12-month follow up
body weight
weight in kilograms
Time frame: 3 month, 6 month and 12-month follow up
BMI
weight and height will be combined to report BMI in kg/m\^2
Time frame: 3 month, 6 month and 12-month follow up
Metabolic syndrome
defined as 3 or more of 5 components (ie, abdominal obesity, elevated blood pressure, elevated triglycerides, low high-density lipoprotein cholesterol, and dysglycemia)
Time frame: 3 month, 6 month and 12-month follow up
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MMH
Taipei, Zhongshan Dist., Taiwan