NCT00464984

Brief Summary

The long term effects of organized lifestyle intervention on weight loss, physical fitness and quality of life in morbidly obese patients have not been extensively studied. The objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitating) is superior to lifestyle intervention in a primary care setting with respect to long term (4-years) changes in weight loss, physical fitness and quality of life

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2007

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

11.3 years

First QC Date

April 23, 2007

Last Update Submit

August 31, 2021

Conditions

Morbid Obesity

Keywords

Weight lossPhysical fitnessQuality of life

Outcome Measures

Primary Outcomes (1)

  • Weight loss, physical fitness and quality of life

    1 and 4 years

Study Arms (2)

ILI-group

ACTIVE COMPARATOR

Intensive lifestyle intervention at a tertiary care rehabilitation center. Treatment included changes in both dietary habits (calori restriction) and physical activity with particularly high intensity the first 3 months.

Behavioral: Lifestyle intervention

MLI

ACTIVE COMPARATOR

Moderate lifestyle intervention at a secondary care outpatient center. Treatment included moderate changes in dietary habits (calori restriction) and physical activity.

Behavioral: Lifestyle intervention

Interventions

Lifestyle interventionBEHAVIORAL

Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study

ILI-groupMLI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Morbidly obese patients not planned for bariatric surgery

You may not qualify if:

  • Participation in other weight loss programs during the last 12 mths
  • Serious psychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spesialsykehuset for Rehabilitering i Stavern

Stavern, Vestfold, Norway

Location

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Jøran Hjelmesæth, MD, PhD

    Morbid Obesity Center, Hospital of Vestfold, Boks 2168, NORWAY

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Morbid Obesity Centre

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 24, 2007

Study Start

August 1, 2006

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

NO(1)