Back to resultsInterventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care (LÄTTA)
Primary Purpose
Overweight/Obesity
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intensive lifestyle counseling
Sponsored by
About this trial
This is an interventional treatment trial for Overweight/Obesity
Eligibility Criteria
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.
Sites / Locations
- Orebro County Council
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intensive lifestyle counseling
Usual care
Arm Description
Both dietary advice and individualized advice on increased regular physical activity.
Usual care
Outcomes
Primary Outcome Measures
Proportion of patients who achieved target weight at two years
Secondary Outcome Measures
Clinical or laboratory manifestations of their baseline illness (type 2 diabetes, hypertension, CHD, dyslipidemia) or death of any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01606917
Brief Title
Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care
Acronym
LÄTTA
Official Title
Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight/Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive lifestyle counseling
Arm Type
Experimental
Arm Description
Both dietary advice and individualized advice on increased regular physical activity.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Intensive lifestyle counseling
Intervention Description
Both dietary advice and individualized advice on increased regular physical activity
Primary Outcome Measure Information:
Title
Proportion of patients who achieved target weight at two years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Clinical or laboratory manifestations of their baseline illness (type 2 diabetes, hypertension, CHD, dyslipidemia) or death of any cause.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan P.O Jansson, MD PhD student
Organizational Affiliation
Family Medicine Research Centre, Örebro County Council, School of Health and Medical Sciences, Örebro University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orebro County Council
City
Orebro
ZIP/Postal Code
70116
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
23711165
Citation
Jansson SP, Engfeldt P, Magnuson A, Pt GL, Liljegren G. Interventions for lifestyle changes to promote weight reduction, a randomized controlled trial in primary health care. BMC Res Notes. 2013 May 27;6:213. doi: 10.1186/1756-0500-6-213.
Results Reference
derived
Links:
URL
http://www.orebroll.se/sv/Forskning/Forskningsomraden/Allmanmedicin1/
Description
Medicine Research Centre
Learn more about this trial
Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care
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