Completed

Intensive Lifestyleintervention for the Treatment of Severe Obesity

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What is being tested

Intensive lifestyle intervention

Behavioral
Who is being recruted

Behavior+8

+ Body Weight

+ Nutrition Disorders

From 18 to 65 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2009
See protocol details

Summary

Principal SponsorNorwegian School of Sport Sciences
Last updated: April 15, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2009

Actual date on which the first participant was enrolled.

The study is based on data collected from patients at The Hjelp24 NIMI Ringerike Obesity Clinic, which is an inpatient program to address morbid obesity in adults. The study is a non-randomized clinical trial comparing the acute and long-term effects on physical and psychological health of the 10-14-weeks inpatient comprehensive lifestyle modification program for the treatment of morbidly obese patients. In between the inpatient stay, the patients are followed up either by telephone, occasional mail and/or structured / weekly email. In this project we prospectively follow two groups of patient included in the treatment programme in September 2010 and January 2011, respectively. In addition a control group with waiting-list patients is also included in the study, and they were recruited in October-November 2011

NCT01675713
Principal SponsorNorwegian School of Sport Sciences
Last updated: April 15, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

149 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBody WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightMotor ActivityObesity, Morbid

Criteria

1 inclusion criteria required to participate
morbidly obese
1 exclusion criteria prevent from participating
not able to walk slowly for 20 minutes

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
10-14 weeks intensive lifestyle intervention

Group II

No Intervention
No treatment, waiting list

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Norwegian School of Sport Sciences

Oslo, NorwayOpen Norwegian School of Sport Sciences in Google Maps
CompletedOne Study Center