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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01606917
Other study ID # OrebroCC
Secondary ID
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


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
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