Clinical trial NCT03593148: The Effect of Lifestyle Treatment in Patients With Morbid Obesity
Official title: The Effect of Lifestyle Treatment on Physical Capacity, Maximal Strength, Eating Behavior and Quality of Life in Patients With Morbid Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Capacity
Leg Strength
Eating Behavior
Life of Quality
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: University college of south-east Norway
First posted: 2018-07-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effect of lifestyle treatment on physical capacity, maximal strength, eating behavior and quality of life in patients with morbid obesity (LIFETIME)

Detailed description: In this study, the investigators will investigate whether more intensive day-based lifestyle treatment process have a better effect on weight loss and health-related quality of life than a previous treatment. Investigators also want to investigate whether patients with good physical capacity (maximal oxygen uptake) and bone strength (maximum bone strength) before initiating treatment and / or after 3 and 6 months intensive training may have greater weight loss 1 and 2 years after treatment than patients with lower physical capacity and bone strength.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Weight change at 2-year follow up
timeFrame: Changes from baseline body weight at 2-year follow up.
Secondary outcomes:
measure: Maximal leg strength change at 2-year follow up
timeFrame: Changes from baseline maximal leg strenght at 2-year follow up.
measure: Physical capacity change at 2-year follow up
timeFrame: Changes from baseline physical capacity at 2-year follow up.
measure: Health-related quality of life (HRQoL) - Short Form Health Survey (RAND-36), change at 2-year follow up
timeFrame: Changes from baseline RAND-36 at 2-year follow up.
measure: Health-related quality of life (HRQoL) - Impact on Weight Questionnaire (IWQOL-Lite), change at 2-year follow up
timeFrame: Changes from baseline IWQOL-Lite at 2-year follow up.
measure: Health-related quality of life (HRQoL) - Weight-Related Symptom Measure (WRSM), change at 2-year follow up
timeFrame: Changes from baseline WRSM at 2-year follow up.
measure: Binge Eating Scale (BES), change at 2-year follow up
timeFrame: Changes from baseline BES at 2-year follow up.
measure: The Power of Food scale (PFS) change at 2-year follow up
timeFrame: Changes from baseline PES at 2-year follow up.
measure: Weight change at 1-year follow up
timeFrame: Changes from baseline body weight at 1-year follow up.
measure: Three Factor Eating Questionnaire (TFEQ - R21)
timeFrame: Changes from baseline TFEQ-R21 at 2-year follow up.
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Jarle Berge
Study officials:
affiliation: The Hospital of Vestfold
name: Jens Hertel, PhD
role: PRINCIPAL_INVESTIGATOR
References: