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

Overweight/Obesity Clinical Trial

— LÄTTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606917
• Other study ID #: OrebroCC
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: May 25, 2012
• Start date: October 2004
• Est. completion date: October 2011

Study information

• Verified date: May 2012
• Source: Örebro County Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight/Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Sweden	Orebro County Council	Orebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro County Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who achieved target weight at two years		2 years	No
Secondary	Clinical or laboratory manifestations of their baseline illness (type 2 diabetes, hypertension, CHD, dyslipidemia) or death of any cause.		5 years	No