PreDiabetes
Conditions
Keywords
lifestyle intervention, prediabetes
Brief 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.
Interventions
BEHAVIORALlifestyle 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.
Sponsors
Ministry of Health and Welfare, Taiwan
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* 40 years old or over * elevated fasting plasma glucose concentrations (FPG: 100-125 mg/dl) or glycated hemoglobin(HbA1C: 5.7-6.3%)
Exclusion criteria
* having received a diagnosis of diabetes or receiving treatment for diabetes in 3 years * having a history of cardiovascular disease, stroke, liver disease, kidney disease, cardiopulmonary disease, malignancy or cancer and musculoskeletal impairment * receiving corticosteroids, androgens, estrogen containing compounds * who had dietary problem * pregnant women * who joined other health intervention study in one year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood sugar | 3 month, 6 month and 12-month follow up | changes in fasting glucose and glycated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body weight | 3 month, 6 month and 12-month follow up | weight in kilograms |
| BMI | 3 month, 6 month and 12-month follow up | weight and height will be combined to report BMI in kg/m\^2 |
| Metabolic syndrome | 3 month, 6 month and 12-month follow up | defined as 3 or more of 5 components (ie, abdominal obesity, elevated blood pressure, elevated triglycerides, low high-density lipoprotein cholesterol, and dysglycemia) |
Countries
Taiwan
Contacts
Primary ContactHung-Yi Chiou, PhD
Backup ContactYu-Ling Li, PhD student
Outcome results
None listed