GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes

February 13, 2008 updated by: Finnish Institute for Health and Welfare

GOAL Life-Style Change Implementation Intervention to Prevent Type 2 Diabetes in Primary Health Care

Life-style change achieved in controlled experimental condition has been shown to prevent type 2 diabetes. The purpose of this study is to evaluate to what extent the life-style change can be achieved in a routine health care setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The GOAL (Good Ageing in Lahti region) Program Life-style change implementation trial to prevent type 2 diabetes was set to examine and enhance the effectiveness of life-style change counselling in the primary health care. In the intervention, specific nutritional, physical activity and weight loss objectives shown effective in diabetes prevention in an earlier randomised controlled trial are used as a benchmark, embedded in a structured group counselling model with an empowerment-oriented approach and adapted into the primary health care setting. In the trial, effectiveness and process are evaluated, the analyses including gender and socio-economic differences. Participants were 361 middle-aged (50-65 yrs) adults at an increased risk for type 2 diabetes, recruited in 16 primary health care centres in Paijat-Hame, Finland. Intervention and data collection took place in year 2003.

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Finland
      • Lahti, Finland, 15850
        • Päijät-Häme Hospital District

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

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes risk test score > 11 (Lindstrom & Tuomilehto, 2003)

Exclusion Criteria:

  • mental health problem or substance abuse likely to interfere with participation
  • acute cancer
  • type 2 diabetes requiring pharmacological treatment
  • myocardial infarction during the past six months

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Behavioral: Cognitive-behavioral life-style counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nutrition (fat, fiber)
Time Frame: 0-1 years
0-1 years
Physical activity
Time Frame: 0-3 years
0-3 years
Weight
Time Frame: 0-3 years
0-3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Waist circumference
Time Frame: 0-3 years
0-3 years
Plasma glucose (fasting, 2 hr challenge)
Time Frame: 0-3 years
0-3 years
Serum lipids
Time Frame: 0-3 years
0-3 years
Blood pressure (diastolic, systolic)
Time Frame: 0-3 years
0-3 years

Collaborators and Investigators

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

Sponsor

Finnish Institute for Health and Welfare

Collaborators

Academy of Finland

Investigators

  • Study Director: Antti Uutela, PhD, National Public Health Institute
  • Principal Investigator: Pilvikki Absetz, PhD, National Public Health Institute
  • Study Director: Martti Talja, PhD, Päijät-Häme Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

November 9, 2006

First Posted (Estimate)

November 10, 2006

Study Record Updates

Last Update Posted (Estimate)

February 14, 2008

Last Update Submitted That Met QC Criteria

February 13, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTL223-3

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.

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