Maintenance Programme After Weight Loss

January 9, 2008 updated by: University of Helsinki

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Vantaa, Finland, 01400
        • Peijas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight result
Time Frame: 2 years after weight loss phase
2 years after weight loss phase

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life and eating behavior
Time Frame: 2 years after active weight loss
2 years after active weight loss

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Finnish Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 10, 2008

Last Update Submitted That Met QC Criteria

January 9, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231410
  • Finnish Medical Foundation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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