The Effect of Lifestyle Treatment in Patients With Morbid Obesity
LIFETIME
1 other identifier
interventional
600
1 country
1
Brief Summary
The effect of lifestyle treatment on physical capacity, maximal strength, eating behavior and quality of life in patients with morbid obesity (LIFETIME)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
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, 2017
CompletedFirst Submitted
Initial submission to the registry
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2025
CompletedSeptember 1, 2021
August 1, 2021
8.7 years
April 30, 2018
August 31, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Weight change at 2-year follow up
Effect of intensive treatment on weight loss changes at 2- year follow up. Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and at 2-year follow up.
Changes from baseline body weight at 2-year follow up.
Secondary Outcomes (9)
Maximal leg strength change at 2-year follow up
Changes from baseline maximal leg strenght at 2-year follow up.
Physical capacity change at 2-year follow up
Changes from baseline physical capacity at 2-year follow up.
Health-related quality of life (HRQoL) - Short Form Health Survey (RAND-36), change at 2-year follow up
Changes from baseline RAND-36 at 2-year follow up.
Health-related quality of life (HRQoL) - Impact on Weight Questionnaire (IWQOL-Lite), change at 2-year follow up
Changes from baseline IWQOL-Lite at 2-year follow up.
Health-related quality of life (HRQoL) - Weight-Related Symptom Measure (WRSM), change at 2-year follow up
Changes from baseline WRSM at 2-year follow up.
- +4 more secondary outcomes
Study Arms (1)
Lifestyle treatment
OTHERPatients will be included in the Lifestyle treatment that is a existing treatment program at Vestfold Hospital Trust.
Interventions
Eligibility Criteria
You may qualify if:
- Treatment seeking morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the Vestfold Hospital Trust.
You may not qualify if:
- Uncompensated heart failure
- Recent myocardial infarction or stroke (\<½ years)
- Severe arrhythmia or heart failure
- Unstable angina pectoris
- Renal failure
- Pregnancy
- Severe eating disorders
- Active substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sykehuset i Vestfold HFlead
- University college of south-east Norwaycollaborator
Study Sites (1)
Jarle Berge
Tønsberg, 3103, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Hertel, PhD
The Hospital of Vestfold
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 30, 2018
First Posted
July 19, 2018
Study Start
April 1, 2017
Primary Completion
December 23, 2025
Study Completion
December 23, 2025
Last Updated
September 1, 2021
Record last verified: 2021-08