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Maintenance Programme After Weight Loss

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590655
First Posted: January 10, 2008
Last Update Posted: January 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Finnish Medical Foundation
Information provided by:
Helsinki University
  Purpose
The aim of this study is to compare a weight reduction programme with and without a maintenance programme in patients with severe obesity.

Condition Intervention
Weight Loss Morbid Obesity Behavioral: weight loss programme with maintenance programme Behavioral: weight loss programme

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Maintenance Programme on the Long Term Weight Reduction in Severely Obese Patients. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • weight result [ Time Frame: 2 years after weight loss phase ]

Secondary Outcome Measures:
  • quality of life and eating behavior [ Time Frame: 2 years after active weight loss ]

Enrollment: 201
Study Start Date: August 2002
Study Completion Date: May 2006
Arms Assigned Interventions
Active Comparator: 2
Treatment B includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). Treatment lasts 17 weeks and after that there will be one and two year control visits including weighing and questionnaires for eating behavior and quality of life.
Behavioral: weight loss programme
Experimental: 1
Treatment includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). After that a maintenance programme starts with monthly sessions for one year. Weight loss, quality of life, and eating behavior will be assessed at the end of the maintenance program and one year later.
Behavioral: weight loss programme with maintenance programme
After usual weight loss treatment, there will be a one-year maintenance programme with monthly visits.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590655


Locations
Finland
Peijas Hospital
Vantaa, Finland, 01400
Sponsors and Collaborators
Helsinki University
Finnish Medical Foundation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tuula Pekkarinen, Peijas Hospital, Department of Internal medicine
ClinicalTrials.gov Identifier: NCT00590655     History of Changes
Other Study ID Numbers: 231410
Finnish Medical Foundation
First Submitted: December 26, 2007
First Posted: January 10, 2008
Last Update Posted: January 10, 2008
Last Verified: December 2007

Keywords provided by Helsinki University:
maintenance therapy

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