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GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes

F

Finnish Institute for Health and Welfare

Status and phase

Completed
Phase 3

Conditions

Obesity
Type 2 Diabetes

Treatments

Behavioral: Cognitive-behavioral life-style counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT00398060
KTL223-3

Details and patient eligibility

About

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.

Full 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.

Enrollment

389 patients

Sex

All

Ages

50 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

389 participants in 1 patient group

A
Experimental group
Treatment:
Behavioral: Cognitive-behavioral life-style counseling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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