Long Term Follow up After 1 Year Initial Lifestyle Intervention

August 26, 2024 updated by: Tor-Ivar Karlsen

Effect of Four Years Intensive- Versus Regular Follow up, After a One Year Weight Loss Period, in Patients With Morbid Obesity.

The effect of non-surgical methods for obesity treatment are not fully documented. This study focus on the long term effect of an intensiv follow up (the "Evje Model") compared to a regular follow up.

The "Evje Model" is a combined model, consisting of repeated stays at a specialist centre, telephone follow up at home, home groups, self monitoring and close contact with the patients' local physician.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

200 patients will undergo a 1 year intensive lifestyle intervention.This group will be randomised into an intervention group (n=100) and a control group (n=100). The intervention group will undergo four years of further follow up in accordance with the intervention model, which means two one weeks stays each year at the Evje Clinic, telephone follow up, self monitoring and collaboration with the patients' local physician.

The control group will be followed up by the patients local physician and a yearly control at the Center for Morbid Obesity at Vestfold Hospital (Sykehuset i Vestfold HF).

The purpose is to measure the effect of these two follow up models in regard to weight loss maintanance, Quality of Life and comorbidities.

Study Type

Interventional

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

  • Norway
    • Evjemoen
      • Evje, Evjemoen, Norway, 4735
        • Evjeklinikken AS

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 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients, referred from Public Hospitals, with morbid obesity that have undergone one year intensive life style intervention in accordance with the Evje Model.

Exclusion Criteria:

  • Pregnancy, major and active psychiatric disease, active and serious eating disorder

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
No Intervention: Control
Control group
Other: Intervention
Receiving active follow up (two yearly 1 week stays, telephone follow up, GP-visits)
Behavioral: Long term follow up after intensive lifestyle intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 03.2015
03.2015

Secondary Outcome Measures

Outcome Measure
Time Frame
Health related quality of life
Time Frame: 03.2015
03.2015
Anthropometrics
Time Frame: 03.2015
03.2015

Collaborators and Investigators

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

Sponsor

Tor-Ivar Karlsen

Collaborators

Sykehuset i Vestfold HF

Investigators

  • Study Chair: Joran Hjelmesath, Dr. Med., Sykehuset I Vestfold HF

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

Helpful Links

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 (Estimated)

May 1, 2007

Primary Completion (Estimated)

March 1, 2015

Study Completion (Estimated)

November 1, 2015

Study Registration Dates

First Submitted

May 22, 2007

First Submitted That Met QC Criteria

May 22, 2007

First Posted (Estimated)

May 23, 2007

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK0701

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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