Lifestyle Modification Intervention in Pre-diabetic Subjects

July 5, 2017 updated by: Taipei Medical University

Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Lingya Dist
      • Kaohsiung, Lingya Dist, Taiwan, 802
        • Active, not recruiting
        • YUANH
    • Shilin Dist.
      • Taipei, Shilin Dist., Taiwan, 111
        • Recruiting
        • SKH
        • Contact:
    • Sinyi District,
      • Taipei, Sinyi District,, Taiwan, 110
        • Recruiting
        • TMUH
        • Contact:
    • Zhongshan Dist.
      • Taipei, Zhongshan Dist., Taiwan, 104
        • Recruiting
        • MMH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood sugar
Time Frame: 3 month, 6 month and 12-month follow up
changes in fasting glucose and glycated hemoglobin
3 month, 6 month and 12-month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight
Time Frame: 3 month, 6 month and 12-month follow up
weight in kilograms
3 month, 6 month and 12-month follow up
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 month, 6 month and 12-month follow up
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)
3 month, 6 month and 12-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Collaborators

Ministry of Health and Welfare, Taiwan

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2012

Primary Completion (Actual)

March 18, 2013

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

July 5, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201110024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PreDiabetes

Clinical Trials on lifestyle modification intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe