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Completed

NCT Number: NCT00398060

GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes

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.

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Key information

Conditions

Obesity Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms Type 2 Diabetes

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Päijät-Häme Hospital District

Lahti, 15850, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavioral life-style counseling

Behavioral

Primary outcomes

  1. Nutrition (fat, fiber)

    Time frame: 0-1 years

  2. Physical activity

    Time frame: 0-3 years

  3. Weight

    Time frame: 0-3 years

Secondary outcomes

  1. Waist circumference

    Time frame: 0-3 years

  2. Plasma glucose (fasting, 2 hr challenge)

    Time frame: 0-3 years

  3. Serum lipids

    Time frame: 0-3 years

  4. Blood pressure (diastolic, systolic)

    Time frame: 0-3 years

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Collaborators

  • Academy of Finland

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2007
First posted
Nov 10, 2006
Registry last updated
Feb 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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