GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Academy of Finland
Information provided by:
National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT00398060
First received: November 9, 2006
Last updated: February 13, 2008
Last verified: February 2008
  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: 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 ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist circumference [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]
  • Plasma glucose (fasting, 2 hr challenge) [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]
  • Serum lipids [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]
  • Blood pressure (diastolic, systolic) [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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 Päijät-Häme Central Hospital
  More Information

Additional 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
Study First Received: November 9, 2006
Last Updated: February 13, 2008
Health Authority: Finland: Ethics Committee

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
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014