ObesityPhase 3NCT00398060
GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes
A Phase 3 study testing Cognitive-behavioral life-style counseling in people with Obesity and Type 2 Diabetes, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Cognitive-behavioral life-style counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2003to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes risk test score > 11 (Lindstrom \& Tuomilehto, 2003)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Cognitive-behavioral life-style counseling
- Keywords
- life-style counseling, type 2 diabetes, prediabetes, physical activity, diet, cognitive-behavioral
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral life-style counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Behavioral: Cognitive-behavioral life-style counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition (fat, fiber)
Measured: 0-1 years
Physical activity
Measured: 0-3 years
Weight
Measured: 0-3 years
Secondary outcomes (4)
Waist circumference
Measured: 0-3 years
Plasma glucose (fasting, 2 hr challenge)
Measured: 0-3 years
Serum lipids
Measured: 0-3 years
Blood pressure (diastolic, systolic)
Measured: 0-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startJan 2003
- Primary completionDec 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Academy of Finland
- Investigators
- Antti Uutela, PhD, Study director, National Public Health InstitutePilvikki Absetz, PhD, Principal investigator, National Public Health InstituteMartti Talja, PhD, Study director, Päijät Häme Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398060
- Sponsor's protocol ID
- KTL223-3
- Status last verified
- Feb 2008
- First submitted
- 9 Nov 2006
- Last updated
- 14 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14683570
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GOAL Life-Style Change Implementation Intervention to Prevent Type 2 Diabetes in Primary Health Care
- ClinicalTrials.gov ID
- NCT00398060
- Acronym / sponsor ID
- KTL223-3
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- life-style counseling, type 2 diabetes, prediabetes, physical activity, diet, cognitive-behavioral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Academy of Finland
- Study start
- Jan 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 10 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Cognitive-behavioral life-style counseling |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes risk test score > 11 (Lindstrom \& Tuomilehto, 2003)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral life-style counseling | Behavioural | A |
Primary outcome
Nutrition (fat, fiber)
Time frame: 0-1 years
Physical activity
Time frame: 0-3 years
Weight
Time frame: 0-3 years
4 secondary outcomes
Waist circumference
Time frame: 0-3 years
Plasma glucose (fasting, 2 hr challenge)
Time frame: 0-3 years
Serum lipids
Time frame: 0-3 years
Blood pressure (diastolic, systolic)
Time frame: 0-3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2008.
- Background: PubMed 14683570Uutela 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antti Uutela, PhD study director
National Public Health Institute
Pilvikki Absetz, PhD principal investigator
National Public Health Institute
Martti Talja, PhD study director
Päijät Häme Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive-behavioral life-style counseling in people with Obesity and Type 2 Diabetes, run by Finnish Institute for Health and Welfare at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition (fat, fiber) (time frame: 0-1 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00398060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2008.