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

Not Applicable

Completed

• Conditions: Overweight/Obesity
• Interventions: Other: Intensive lifestyle counseling

• Registration Number: NCT01606917
• Lead Sponsor: Örebro County Council

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.

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2011-06
• Study Completion: 2011-10
• Status Verified: 2012-05
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-25
• Last Update Submitted: 2012-05-25
• Study First Posted: 2012-05-28
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive lifestyle counseling	Intensive lifestyle counseling	Both dietary advice and individualized advice on increased regular physical activity.

Primary Outcome Measures

Name	Time	Method
Proportion of patients who achieved target weight at two years	2 years

Secondary Outcome Measures

Name	Time	Method
Clinical or laboratory manifestations of their baseline illness (type 2 diabetes, hypertension, CHD, dyslipidemia) or death of any cause.	5 years

Trial Locations

Locations (1)

Orebro County Council; 🇸🇪 Orebro, Sweden