Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health and Welfare, Taiwan | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lifestyle intervention group | Experimental | The intervention group was given healthy lifestyle education and individualized counseling by well-trained case manager at baseline, and follow-up phone counseling thereafter. |
|
| control group | No Intervention | The control group was given general verbal and written health behavior information to prevent diabetes at baseline without specific individualized advice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lifestyle modification intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| blood sugar | changes in fasting glucose and glycated hemoglobin | 3 month, 6 month and 12-month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| body weight | weight in kilograms | 3 month, 6 month and 12-month follow up |
| BMI | weight and height will be combined to report BMI in kg/m^2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hung-Yi Chiou, PhD | Contact | +88627361661 | 6512 | hychiou@tmu.edu.tw |
| Yu-Ling Li, PhD student | Contact | +886227361661 | 6512 | evelyn.tmu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hung-Yi Chiou, PhD | School of Public Health, Taipei Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YUANH | Active, not recruiting | Kaohsiung City | Lingya Dist | 802 | Taiwan | |
| SKH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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) | 3 month, 6 month and 12-month follow up |
| Recruiting |
| Taipei |
| Shilin Dist. |
| 111 |
| Taiwan |
|
| TMUH | Recruiting | Taipei | Sinyi District, | 110 | Taiwan |
|
| MMH | Recruiting | Taipei | Zhongshan Dist. | 104 | Taiwan |
|
| D004700 | Endocrine System Diseases |