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Lifestyle Modification Intervention in Pre-diabetic Subjects
This study is currently recruiting participants.
Verified June 2017 by Taipei Medical University
Sponsor:
Taipei Medical University
Collaborator:
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
Taipei Medical University
ClinicalTrials.gov Identifier:
NCT03211182
First received: June 29, 2017
Last updated: July 5, 2017
Last verified: June 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| PreDiabetes | Behavioral: lifestyle modification intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant Primary Purpose: Prevention |
| Official Title: | Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects |
Resource links provided by NLM:
Further study details as provided by Taipei Medical University:
Primary Outcome Measures:
- blood sugar [ Time Frame: 3 month, 6 month and 12-month follow up ]changes in fasting glucose and glycated hemoglobin
Secondary Outcome Measures:
- body weight [ Time Frame: 3 month, 6 month and 12-month follow up ]weight in kilograms
- BMI [ Time Frame: 3 month, 6 month and 12-month follow up ]weight and height will be combined to report BMI in kg/m^2
- Metabolic syndrome [ Time Frame: 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)
| Estimated Enrollment: | 300 |
| Actual Study Start Date: | March 7, 2012 |
| Estimated Study Completion Date: | December 31, 2018 |
| Primary Completion Date: | March 18, 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: lifestyle intervention group
The intervention group was given healthy lifestyle education and individualized counseling by well-trained case manager at baseline, and follow-up phone counseling thereafter.
|
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.
|
|
No Intervention: control group
The control group was given general verbal and written health behavior information to prevent diabetes at baseline without specific individualized advice.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211182
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211182
Contacts
| Contact: Hung-Yi Chiou, PhD | +88627361661 ext 6512 | hychiou@tmu.edu.tw | |
| Contact: Yu-Ling Li, PhD student | +886227361661 ext 6512 | evelyn.tmu@gmail.com |
Locations
| Taiwan | |
| YUANH | Active, not recruiting |
| Kaohsiung, Lingya Dist, Taiwan, 802 | |
| SKH | Recruiting |
| Taipei, Shilin Dist., Taiwan, 111 | |
| Contact: Yu-Ling Li, PhD student +886227361661 ext 6512 evelyn.tmu@gmail.com | |
| TMUH | Recruiting |
| Taipei, Sinyi District,, Taiwan, 110 | |
| Contact: Yu-Ling Li, PhD student +886227361661 ext 6512 evelyn.tmu@gmail.com | |
| MMH | Recruiting |
| Taipei, Zhongshan Dist., Taiwan, 104 | |
| Contact: Yu-Ling Li, PhD student +886227361661 ext 6512 evelyn.tmu@gmail.com | |
Sponsors and Collaborators
Taipei Medical University
Ministry of Health and Welfare, Taiwan
Investigators
| Study Chair: | Hung-Yi Chiou, PhD | School of Public Health, Taipei Medical University |
More Information
| Responsible Party: | Taipei Medical University |
| ClinicalTrials.gov Identifier: | NCT03211182 History of Changes |
| Other Study ID Numbers: |
201110024 |
| Study First Received: | June 29, 2017 |
| Last Updated: | July 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Taipei Medical University:
|
lifestyle intervention prediabetes |
Additional relevant MeSH terms:
|
Prediabetic State Glucose Intolerance Diabetes Mellitus Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperglycemia |
ClinicalTrials.gov processed this record on July 11, 2017