- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00398060
GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes
February 13, 2008 updated by: Finnish Institute for Health and Welfare
GOAL Life-Style Change Implementation Intervention to Prevent Type 2 Diabetes in Primary Health Care
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
389
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lahti, Finland, 15850
- Päijät-Häme Hospital District
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Nutrition (fat, fiber)
Time Frame: 0-1 years
|
0-1 years
|
Physical activity
Time Frame: 0-3 years
|
0-3 years
|
Weight
Time Frame: 0-3 years
|
0-3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Waist circumference
Time Frame: 0-3 years
|
0-3 years
|
Plasma glucose (fasting, 2 hr challenge)
Time Frame: 0-3 years
|
0-3 years
|
Serum lipids
Time Frame: 0-3 years
|
0-3 years
|
Blood pressure (diastolic, systolic)
Time Frame: 0-3 years
|
0-3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Antti Uutela, PhD, National Public Health Institute
- Principal Investigator: Pilvikki Absetz, PhD, National Public Health Institute
- Study Director: Martti Talja, PhD, Päijät-Häme Central Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
December 1, 2004
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
November 9, 2006
First Submitted That Met QC Criteria
November 9, 2006
First Posted (Estimate)
November 10, 2006
Study Record Updates
Last Update Posted (Estimate)
February 14, 2008
Last Update Submitted That Met QC Criteria
February 13, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KTL223-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Cognitive-behavioral life-style counseling
-
Sykehuset Innlandet HFThe Royal Norwegian Ministry of HealthCompleted
-
Clalit Health ServicesCompleted
-
Aga Khan UniversityUniversity of Helsinki; International Diabetes FederationUnknownPrediabetic State & High Risk IndividualsPakistan
-
University of BolognaIRCCS Azienda Ospedaliero-Universitaria di BolognaCompleted
-
University of TurkuUnknownAtherosclerosisFinland
-
University of California, San FranciscoSan Francisco Department of Public Health; San Francisco General Hospital; Sonoma...CompletedType 2 Diabetes Mellitus | Gestational Diabetes MellitusUnited States
-
Tzu-Ting HuangCompletedPhysical Activity | Mild Cognitive Impairment | Cognitive Rehabilitation | TTM
-
Mayo ClinicJames and Esther King Biomedical Research ProgramCompletedfor Cigarette Smoking and Binge Drinking CessationUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingObesity-Related Malignant NeoplasmUnited States
-
Radboud University Medical CenterCompletedCardiovascular DiseasesNetherlands