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

  • Sweden
      • Orebro, Sweden, 70116
        • Örebro County Council

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
Experimental: Intensive lifestyle counseling
Both dietary advice and individualized advice on increased regular physical activity.
Other: Intensive lifestyle counseling
Both dietary advice and individualized advice on increased regular physical activity

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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Örebro County Council

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.

General Publications

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.

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