NCT00477399

Brief Summary

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.

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 May 2007

Longer than P75 for not_applicable obesity

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withdrawn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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2007

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

7.8 years

First QC Date

May 22, 2007

Last Update Submit

August 26, 2024

Conditions

Obesity

Keywords

ObesityWeight loss maintenanceQOLLife StyleFollow Up

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    03.2015

Secondary Outcomes (2)

  • Health related quality of life

    03.2015

  • Anthropometrics

    03.2015

Study Arms (2)

Intervention

OTHER

Receiving active follow up (two yearly 1 week stays, telephone follow up, GP-visits)

Behavioral: Long term follow up after intensive lifestyle intervention

Control

NO INTERVENTION

Control group

Interventions

Long term follow up after intensive lifestyle interventionBEHAVIORAL
Intervention

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evjeklinikken AS

Evje, Evjemoen, 4735, Norway

Location

Related Publications (1)

  • Karlsen TI, Sohagen M, Hjelmesaeth J. Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Health Qual Life Outcomes. 2013 Oct 3;11:165. doi: 10.1186/1477-7525-11-165.

    PMID: 24090083DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joran Hjelmesath, Dr. Med.

    Sykehuset i Vestfold HF

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
RN PhD

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 23, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2015

Study Completion

November 1, 2015

Last Updated

August 28, 2024

Record last verified: 2024-08

Locations

NO(1)