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Sponsors and Collaborators: |
National Institute for Health and Welfare, Finland Academy of Finland |
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Information provided by: | National Institute for Health and Welfare, Finland |
ClinicalTrials.gov Identifier: | NCT00398060 |
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 III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | GOAL Life-Style Change Implementation Intervention to Prevent Type 2 Diabetes in Primary Health Care |
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 |
---|---|
A: Experimental | Behavioral: Cognitive-behavioral life-style counseling |
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.
Ages Eligible for Study: | 50 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Finland | |
Päijät-Häme Hospital District | |
Lahti, Finland, 15850 |
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 |
Responsible Party: | National Public Health Institute ( Senior researcher Pilvikki Absetz ) |
Study ID Numbers: | KTL223-3 |
Study First Received: | November 9, 2006 |
Last Updated: | February 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00398060 History of Changes |
Health Authority: | Finland: Ethics Committee |
life-style counseling type 2 diabetes prediabetes |
physical activity diet cognitive-behavioral |
Obesity Metabolic Diseases Glucose Intolerance Diabetes Mellitus Prediabetic State Endocrine System Diseases Overweight Body Weight |
Signs and Symptoms Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Body Weight Signs and Symptoms Obesity Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Nutrition Disorders Endocrine System Diseases Overweight Overnutrition Glucose Metabolism Disorders |