Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

NCT01085682 | Completed Phase 4 Results

• 1 other identifier: KCMC07OT255
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to test the possibility of preventing or delaying the development of type 2 diabetes in individuals with impaired glucose tolerance and elevated fasting plasma glucose concentrations by internet-based diabetes prevention program.

Conditions

Type 2 Diabetes

Keywords

Diabetes prevention; Lifestyle modification; Obesity; Impaired glucose tolerance; Diet; Physical activity

Outcome Measures

Primary Outcomes (1)

• Incidence of Type 2 Diabetes Mellitus

  Incidence of type 2 diabetes mellitus

  one year follow up

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR

Behavioral: Lifestyle counseling

Standard care

ACTIVE COMPARATOR

Behavioral: Standard care

Interventions

Lifestyle counseling BEHAVIORAL

In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.

Lifestyle counseling

Standard care BEHAVIORAL

In standard care group, counseling sessions are conducted only 6 times for 4 years

Standard care

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 30-69 years
• BMI ≥ 20 kg/m2
• Impaired glucose tolerance :
• h postprandial glucose (75 g OGTT) 140-199 mg/dl or Impaired fasting glucose : Fasting plasma glucose 110-125 mg/dl

You may not qualify if:

• Diabetes at baseline
• Cardiovascular disease, cancer requiring treatment in the past 5 years, renal disease
• Unable to communicate with clinic staff, Pregnancy and childbearing

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Chung-ju health care center

Chungju, Chungchungbook-do, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Glucose Intolerance; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Kun-Ho Yoon, professor
• Organization: The Catholic University of Korea

yoonk@catholic.ac.kr

82-2-2258-8281

Study Officials

• Kun-Ho Yoon, M.D., Ph.D.

  Kangnam St.Mary's hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medical doctor

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: March 12, 2010
• Study Start: January 1, 2008
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 12, 2014
• Results First Posted: September 12, 2014

Record last verified: 2014-09

Locations

KR (1)