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NCT00590655 Clinical Trial

Maintenance Programme After Weight Loss

Weight Loss Clinical Trial

Official title:
Effect of Maintenance Programme on the Long Term Weight Reduction in Severely Obese Patients. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00590655
Other study ID # 231410
Secondary ID Finnish Medical
Status Completed
Phase N/A
First received December 26, 2007
Last updated January 9, 2008
Start date August 2002
Est. completion date May 2006

Study information
Verified date December 2007
Source Helsinki University
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare a weight reduction programme with and without a maintenance programme in patients with severe obesity.

Recruitment information / eligibility
Status Completed
Enrollment 201
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- BMI 35 kg/m2 or more

- Age 18-65 years

Exclusion Criteria:

- Type 1 diabetes

- Major alcohol problem

- Acute psychic disease, eating behavior, pregnancy, severe disease (cancer, unstable coronary disease, severe liver or kidney disease), or the patient has been in this treatment within the past 5 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• weight loss programme with maintenance programme
After usual weight loss treatment, there will be a one-year maintenance programme with monthly visits.
• weight loss programme

Locations
Country Name City State
Finland Peijas Hospital Vantaa

Sponsors (2)
Lead Sponsor Collaborator
Helsinki University Finnish Medical Foundation

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary weight result 2 years after weight loss phase Yes
Secondary quality of life and eating behavior 2 years after active weight loss Yes
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