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Maintenance Programme After Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Finnish Medical Foundation
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00590655
First received: December 26, 2007
Last updated: January 9, 2008
Last verified: December 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • weight result [ Time Frame: 2 years after weight loss phase ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590655

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

No publications provided

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
Study First Received: December 26, 2007
Last Updated: January 9, 2008
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University:
maintenance therapy

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

ClinicalTrials.gov processed this record on June 18, 2013