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GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00398060
Enrollment
389
Registered
2006-11-10
Start date
2003-01-31
Completion date
2007-03-31
Last updated
2008-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes

Keywords

life-style counseling, type 2 diabetes, prediabetes, physical activity, diet, cognitive-behavioral

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.

Interventions

BEHAVIORALCognitive-behavioral life-style counseling

Sponsors

Academy of Finland
CollaboratorOTHER
Finnish Institute for Health and Welfare
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Nutrition (fat, fiber)0-1 years
Physical activity0-3 years
Weight0-3 years

Secondary

MeasureTime frame
Waist circumference0-3 years
Blood pressure (diastolic, systolic)0-3 years
Plasma glucose (fasting, 2 hr challenge)0-3 years
Serum lipids0-3 years

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026