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GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398060
First Posted: November 10, 2006
Last Update Posted: February 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Academy of Finland
Information provided by:
National Institute for Health and Welfare, Finland
  Purpose
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.

Condition Intervention Phase
Obesity Type 2 Diabetes Behavioral: Cognitive-behavioral life-style counseling Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: GOAL Life-Style Change Implementation Intervention to Prevent Type 2 Diabetes in Primary Health Care

Resource links provided by NLM:


Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • Nutrition (fat, fiber) [ Time Frame: 0-1 years ]
  • Physical activity [ Time Frame: 0-3 years ]
  • Weight [ Time Frame: 0-3 years ]

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

Enrollment: 389
Study Start Date: January 2003
Study Completion Date: March 2007
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Behavioral: Cognitive-behavioral life-style counseling

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT00398060


Locations
Finland
Päijät-Häme Hospital District
Lahti, Finland, 15850
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
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 Päijänne Tavastia Central Hospital
  More Information

Publications:
Responsible Party: Senior researcher Pilvikki Absetz, National Public Health Institute
ClinicalTrials.gov Identifier: NCT00398060     History of Changes
Other Study ID Numbers: KTL223-3
First Submitted: November 9, 2006
First Posted: November 10, 2006
Last Update Posted: February 14, 2008
Last Verified: February 2008

Keywords provided by National Institute for Health and Welfare, Finland:
life-style counseling
type 2 diabetes
prediabetes
physical activity
diet
cognitive-behavioral

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases