GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes

Phase 3

Completed

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Behavioral: Cognitive-behavioral life-style counseling

• Registration Number: NCT00398060
• Lead Sponsor: Finnish Institute for Health and Welfare

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-12
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Study Completion: 2007-03
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-13
• Last Update Posted: 2008-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Cognitive-behavioral life-style counseling	-

Primary Outcome Measures

Name	Time	Method
Nutrition (fat, fiber)	0-1 years
Physical activity	0-3 years
Weight	0-3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Päijät-Häme Hospital District; 🇫🇮 Lahti, Finland