GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes

Study Overview
=================
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.

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

Conditions
-----------------
Obesity, Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral life-style counseling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Behavioral: Cognitive-behavioral life-style counseling<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition (fat, fiber) |  | 0-1 years | 
| Physical activity |  | 0-3 years | 
| Weight |  | 0-3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
life-style counseling, type 2 diabetes, prediabetes, physical activity, diet, cognitive-behavioral