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Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care (LÄTTA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01606917
First Posted: May 28, 2012
Last Update Posted: May 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stefan Jansson, Örebro County Council
  Purpose
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.

Condition Intervention
Overweight/Obesity Other: Intensive lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care

Resource links provided by NLM:


Further study details as provided by Stefan Jansson, Örebro County Council:

Primary Outcome Measures:
  • Proportion of patients who achieved target weight at two years [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Clinical or laboratory manifestations of their baseline illness (type 2 diabetes, hypertension, CHD, dyslipidemia) or death of any cause. [ Time Frame: 5 years ]

Enrollment: 133
Study Start Date: October 2004
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: Usual care
Usual care

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606917


Locations
Sweden
Orebro County Council
Orebro, Sweden, 70116
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefan Jansson, MD PhD Student, Örebro County Council
ClinicalTrials.gov Identifier: NCT01606917     History of Changes
Other Study ID Numbers: OrebroCC
First Submitted: May 24, 2012
First Posted: May 28, 2012
Last Update Posted: May 28, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes