GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	National Institute for Health and Welfare, Finland Academy of Finland
Information provided by:	National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:	NCT00398060

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 III

MedlinePlus related topics: Diabetes Obesity

U.S. FDA Resources

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

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
A: Experimental	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

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

GOAL Program home page This link exits the ClinicalTrials.gov site

Publications:

Uutela A, Absetz P, Nissinen A, Valve R, Talja M, Fogelholm M. Health psychological theory in promoting population health in Paijat-Hame, Finland: first steps toward a type 2 diabetes prevention study. J Health Psychol. 2004 Jan;9(1):73-84.

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
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

Study placed in the following topic categories:

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
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009