NCT00466362

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

April 25, 2007

Last Update Submit

August 26, 2024

Conditions

Type 2 Diabetes

Keywords

ObesityDiabetesWeightLifestyleFollow up

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life

    2007

Interventions

The Evje ModelBEHAVIORAL

Lifestyle intervention

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Morbidly obese patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evjeklinikken AS

Evje Og Hornnes, Evjemoen, 4735, Norway

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityDiabetes MellitusBody Weight

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tom B Schulz, Dr. Med.

    Evjeklinikken

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
RN

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

April 1, 2007

Primary Completion

January 1, 2008

Study Completion

December 1, 2008

Last Updated

August 28, 2024

Record last verified: 2024-08

Locations

NO(1)