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Lifestyle Modification Intervention in Pre-diabetic Subjects

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ClinicalTrials.gov Identifier: NCT03211182
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
Taipei Medical University

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.

Condition or disease Intervention/treatment Phase
PreDiabetes Behavioral: lifestyle modification intervention Not Applicable

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.

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Study Type : Interventional
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects
Actual Study Start Date : March 7, 2012
Actual Primary Completion Date : March 18, 2013
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. blood sugar [ Time Frame: 3 month, 6 month and 12-month follow up ]
    changes in fasting glucose and glycated hemoglobin


Secondary Outcome Measures :
  1. body weight [ Time Frame: 3 month, 6 month and 12-month follow up ]
    weight in kilograms

  2. 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

  3. 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)



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211182


Contacts
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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
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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
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Study Chair: Hung-Yi Chiou, PhD School of Public Health, Taipei Medical University

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Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT03211182     History of Changes
Other Study ID Numbers: 201110024
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia