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Lifestyle Modification Intervention in Pre-diabetic Subjects

Primary Purpose

PreDiabetes

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
lifestyle modification intervention
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring lifestyle intervention, prediabetes

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • YUANH
  • SKHRecruiting
  • TMUHRecruiting
  • MMHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

lifestyle intervention group

control group

Arm Description

The intervention group was given healthy lifestyle education and individualized counseling by well-trained case manager at baseline, and follow-up phone counseling thereafter.

The control group was given general verbal and written health behavior information to prevent diabetes at baseline without specific individualized advice.

Outcomes

Primary Outcome Measures

blood sugar
changes in fasting glucose and glycated hemoglobin

Secondary Outcome Measures

body weight
weight in kilograms
BMI
weight and height will be combined to report BMI in kg/m^2
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)

Full Information

First Posted
June 29, 2017
Last Updated
July 5, 2017
Sponsor
Taipei Medical University
Collaborators
Ministry of Health and Welfare, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03211182
Brief Title
Lifestyle Modification Intervention in Pre-diabetic Subjects
Official Title
Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 7, 2012 (Actual)
Primary Completion Date
March 18, 2013 (Actual)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
Collaborators
Ministry of Health and Welfare, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
lifestyle intervention, prediabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lifestyle intervention group
Arm Type
Experimental
Arm Description
The intervention group was given healthy lifestyle education and individualized counseling by well-trained case manager at baseline, and follow-up phone counseling thereafter.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group was given general verbal and written health behavior information to prevent diabetes at baseline without specific individualized advice.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle modification intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
blood sugar
Description
changes in fasting glucose and glycated hemoglobin
Time Frame
3 month, 6 month and 12-month follow up
Secondary Outcome Measure Information:
Title
body weight
Description
weight in kilograms
Time Frame
3 month, 6 month and 12-month follow up
Title
BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
3 month, 6 month and 12-month follow up
Title
Metabolic syndrome
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Yi Chiou, PhD
Phone
+88627361661
Ext
6512
Email
hychiou@tmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Ling Li, PhD student
Phone
+886227361661
Ext
6512
Email
evelyn.tmu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Yi Chiou, PhD
Organizational Affiliation
School of Public Health, Taipei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
YUANH
City
Kaohsiung
State/Province
Lingya Dist
ZIP/Postal Code
802
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
SKH
City
Taipei
State/Province
Shilin Dist.
ZIP/Postal Code
111
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Ling Li, PhD student
Phone
+886227361661
Ext
6512
Email
evelyn.tmu@gmail.com
Facility Name
TMUH
City
Taipei
State/Province
Sinyi District,
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Ling Li, PhD student
Phone
+886227361661
Ext
6512
Email
evelyn.tmu@gmail.com
Facility Name
MMH
City
Taipei
State/Province
Zhongshan Dist.
ZIP/Postal Code
104
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Ling Li, PhD student
Phone
+886227361661
Ext
6512
Email
evelyn.tmu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Lifestyle Modification Intervention in Pre-diabetic Subjects

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