Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care (LÄTTA)
May 25, 2012 updated by: Stefan Jansson, Örebro County Council
The purpose of this study is to examine the effects of a weight reduction program in adults, seen in a primary care setting, with overweight/obesity perceived as a health problem or with diseases related to overweight/obesity and ambitions to achieve weight reduction as part of treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients seeking advice for overweight/obesity or illness related to overweight/obesity at eight primary health care centers in Sweden were randomized either to intervention or control care groups with both dietary advice and individualized advice on increased regular physical activity.
Main outcome measures were reduction in body weight of 5 percent or more from study start.
Study Type
Interventional
Enrollment (Actual)
133
Phase
- Not Applicable
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
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-
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Orebro, Sweden, 70116
- Örebro County Council
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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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients between 18 and 70 years of age who consulted or were in care for overweight/obesity with or without type 2 diabetes
- Hypertension, CVD
- Coronary heart disease (CHD)
- Dyslipidemia
- Gallstone or musculoskeletal disorders
Exclusion Criteria:
- Patients were not eligible if they were already taking part in another weight control program
- Understood the Swedish language poorly
- Were mentally ill or had an alcohol or drug addiction.
- Nor were they eligible if they had a physical disability preventing intensified physical activity or were pregnant at study start.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care
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Experimental: Intensive lifestyle counseling
Both dietary advice and individualized advice on increased regular physical activity.
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Both dietary advice and individualized advice on increased regular physical activity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of patients who achieved target weight at two years
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinical or laboratory manifestations of their baseline illness (type 2 diabetes, hypertension, CHD, dyslipidemia) or death of any cause.
Time Frame: 5 years
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5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stefan P.O Jansson, MD PhD student, Family Medicine Research Centre, Örebro County Council, School of Health and Medical Sciences, Örebro University
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.
Helpful Links
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
October 1, 2004
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
May 24, 2012
First Submitted That Met QC Criteria
May 25, 2012
First Posted (Estimate)
May 28, 2012
Study Record Updates
Last Update Posted (Estimate)
May 28, 2012
Last Update Submitted That Met QC Criteria
May 25, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OrebroCC
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.