GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398060
• Other study ID #: KTL223-3
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2006
• Last updated: February 13, 2008
• Start date: January 2003
• Est. completion date: March 2007

Study information

• Verified date: February 2008
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: March 2007
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Cognitive-behavioral life-style counseling

Locations

Country	Name	City	State
Finland	Päijät-Häme Hospital District	Lahti

Sponsors (2)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Academy of Finland

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutrition (fat, fiber)		0-1 years	No
Primary	Physical activity		0-3 years	No
Primary	Weight		0-3 years	No
Secondary	Waist circumference		0-3 years	No
Secondary	Plasma glucose (fasting, 2 hr challenge)		0-3 years	No
Secondary	Serum lipids		0-3 years	No
Secondary	Blood pressure (diastolic, systolic)		0-3 years	No

External Links

•   GOAL Program home page