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Clinical Trials/NCT00398060
NCT00398060
Completed
Phase 3

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

Finnish Institute for Health and Welfare1 site in 1 country389 target enrollmentJanuary 2003

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Obesity
Sponsor
Finnish Institute for Health and Welfare
Enrollment
389
Locations
1
Primary Endpoint
Nutrition (fat, fiber)
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2003
End Date
March 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Finnish Institute for Health and Welfare

Eligibility 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

Outcomes

Primary Outcomes

Nutrition (fat, fiber)

Time Frame: 0-1 years

Physical activity

Time Frame: 0-3 years

Weight

Time Frame: 0-3 years

Secondary Outcomes

  • Waist circumference(0-3 years)
  • Plasma glucose (fasting, 2 hr challenge)(0-3 years)
  • Serum lipids(0-3 years)
  • Blood pressure (diastolic, systolic)(0-3 years)

Study Sites (1)

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