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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stefan Jansson, Örebro County Council
ClinicalTrials.gov Identifier:
NCT01606917
First received: May 24, 2012
Last updated: May 25, 2012
Last verified: May 2012
  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 Blind (Subject, Caregiver)
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 Örebro County Council:

Primary Outcome Measures:
  • Proportion of patients who achieved target weight at two years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Stefan Jansson, MD PhD Student, Örebro County Council
ClinicalTrials.gov Identifier: NCT01606917     History of Changes
Other Study ID Numbers: OrebroCC
Study First Received: May 24, 2012
Last Updated: May 25, 2012
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 17, 2014