Lifestyle Intervention in Obesity, Effect on Diabetes

August 26, 2024 updated by: Tor-Ivar Karlsen

One Year Observational Study on Effects of Lifestyle Intervention in Morbidly Obese Persons With Type 2 Diabetes.

There are evidence from numerous studies on effect of lifestyle intervention in morbidly obese patients with type 2 diabetes. This study examines the effect of the "Evje-model" on type 2 diabetes.

The "Evje-model" is a combined 12 months model, consisting of repeated stays in 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Withdrawn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

Type 2 Diabetes

Intervention / Treatment

Behavioral: The Evje Model

Detailed Description

There will be done QOL-measures, blood- and urine analysis, weight, waist- and hip measurement, blood pressure and VO2-max measurement at baseline, after 6 months and after 12 months.

Study Type

Observational

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 Og Hornnes, 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

Sampling Method

Probability Sample

Study Population

Morbidly obese patients

Description

Inclusion Criteria:

All patients with BMI > 35 with diagnosed type 2 diabetes
Referred to Lifestyle Intervention from a public hospital

Exclusion Criteria:

Pregnancy
Active major psychiatric disease(s)
Active and serious eating disorder
Drug- and/or alcohol dependency

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Health related quality of life Time Frame: 2007	2007

Collaborators and Investigators

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

Sponsor

Tor-Ivar Karlsen

Investigators

Principal Investigator: Tom B Schulz, Dr. Med., Evjeklinikken

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

April 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Estimated)

December 1, 2008

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria