Clinical trial NCT00398060: GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes
Official title: GOAL Life-Style Change Implementation Intervention to Prevent Type 2 Diabetes in Primary Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Type 2 Diabetes
Keywords: life-style counseling
type 2 diabetes
prediabetes
physical activity
diet
cognitive-behavioral
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Academy of Finland
First posted: 2006-11-10
Enrollment: 389
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nutrition (fat, fiber)
timeFrame: 0-1 years
measure: Physical activity
timeFrame: 0-3 years
measure: Weight
timeFrame: 0-3 years
Secondary outcomes:
measure: Waist circumference
timeFrame: 0-3 years
measure: Plasma glucose (fasting, 2 hr challenge)
timeFrame: 0-3 years
measure: Serum lipids
timeFrame: 0-3 years
measure: Blood pressure (diastolic, systolic)
timeFrame: 0-3 years
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Päijät-Häme Hospital District
Study officials:
affiliation: National Public Health Institute
name: Antti Uutela, PhD
role: STUDY_DIRECTOR
affiliation: National Public Health Institute
name: Pilvikki Absetz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Päijät Häme Central Hospital
name: Martti Talja, PhD
role: STUDY_DIRECTOR
References:
citation: Uutela A, Absetz P, Nissinen A, Valve R, Talja M, Fogelholm M. Health psychological theory in promoting population health in Paijat-Hame, Finland: first steps toward a type 2 diabetes prevention study. J Health Psychol. 2004 Jan;9(1):73-84. doi: 10.1177/1359105304036103.