The Effect of Lifestyle Treatment on Physical Capacity, Maximal Strength, Eating Behavior and Quality of Life in Patients With Morbid Obesity
Phase: NA
Conditions: Physical Capacity, Leg Strength, Eating Behavior, Life of Quality
Sponsor: Sykehuset i Vestfold HF

 
 
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The effect of lifestyle treatment on physical capacity, maximal 
strength, eating behavior and quality of life in patients with morbid 
obesity (LIFETIME). 
 
05.06.2018 
Approved by Regional committees for medical and health research ethics, Norwegian. ID 2017/88 

 
 
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Background  
Severe obesity is associated with an increased risk of developing type 2 diabetes, obstructive sleep 
apnea, cardiovascular disease, certain types of cancer and early death (1, 2). The main objective for 
the treatment of morbid obesity is weight reduction through behavioral change. There is evidence 
that a weight loss of 5-10% reduces the risk of cardiovascular disease in patients with obesity (3, 4), 
while patients with morbid obesity should achieve a greater weight loss in order to achieve 
improvement in the obesity- related disease (5, 6). More knowledge is needed for establishing the 
most effective treatment methods to reduce weight-related complications and health risk associated 
with obesity. 
 
Severe obesity is associated with reduced health-related quality of life (HRQOL) (7, 8). HRQOL is 
about how people perceive different aspects of their state of health before, during and after an 
intervention or a course. Usually, the HRQOL is measure using standardized questionnaires that 
measure different aspects (physical, mental, emotional, work-related HRQOL, etc.). HRLK is an 
important parameter for assessing the accuracy of a treatment in relation to how the results are 
perceive. Morbid obesity is associated with overeating and an unfortunate eating pattern. It is 
therefore also important to map the patients' intake of food and also attitudes to and experiences 
with meal situations. 
 
Physical inactivity may lead to reduced years of life, physical capacity, physical strength, quality of 
life, energy expenditure, sleep quality, appetite regulation, and increased degree of dysfunctional 
eating behavior (9-11). Increased physical activity prevent overweight and help reduce weight (12, 
13) and some studies have suggested that an increase in physical capacity of 8-21% can increase daily 
energy expenditure by 70-500 kilocalories, which may result in 1.5 to 10 kg weight reduction in one 
year (14, 15). Physical capacity may also be important for weight stabilization after weight loss (9, 
16). A combination of physical activity and calorie reduction is therefore appropriate to decrease 
body weight (17). One of the few studies that mapped physical capacity after a lifestyle treatment 
found no significant change in body weight or physical capacity (18). However, the researchers found 
greatest weight loss in patients with the greatest progress in physical capacity. However, it is not 
clear how physical activity and capacity affect the loss or maintenance of body weight in patients 
with morbid obesity. Implementing strength training in weight-reducing treatment of people with 
morbid obesity can lead to reduced loss or increased muscle mass and maximum muscle strength 
(19-21). Some studies suggest that maintenance or an increase in muscle mass during weight 
reduction is beneficial to increase total energy expenditure (21). A 1-3 kg increase in muscle mass can 
result in increased energy expenditure at rest of 8-10%(11, 22). Some studies suggest that 
maintenance or an increase in muscle mass during weight reduction is beneficial to increase total 
energy consumption (23-25). 
 
In summary, it is still uncertainty about which is the most effective lifestyle treatment methode to 
achived reduce body weight and increased quality of life. Increased physical capacity and muscle 
mass lead to increased energy expenditure, thus explaining parts of the difference in weight loss 
achieved after lifestyle treatment. However, literature in this area is limited and need better 
documentation of how, and to what extent increased physical capacity and muscle mass can affect 
the effect of lifestyle treatment offered to patients in the health service. 

 
 
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Research questions 
In this study, we 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 (26). We 
also want to investigate whether patients with good physical capacity (maximal oxygen uptake) and 
leg strength (maximum leg 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 leg strength. 
 
This issue will be illustrate by the following hypotheses: 
1. An intensification of treatment will result in greater weight loss and increase health-related 
quality of life than previous treatment. 
 
2. Physical capacity (maximum oxygen uptake) before treatment is associate with increase 
weight loss after 3-6 months and 1-2 years. 
 
 
3. Increase leg strength (maximal leg strength) after 3-6 months is associate with increase 
weight loss after 1-2 years. 
Data   
Standard treatment at Vestfold Hospital Trust, the following data is obtained at baseline, between 3-
6 months and between 1-2 years after treatment start: body weight, hip circumference, waist 
circumference, body composition, body mass index, height, age, sex, physical capacity (maximal 
oxygen uptake) and leg strength (maximal leg strength). In the study, we will use data from 600 
patients to research the study's hypotheses over a period of 8 years (2017-2025). 
Body weight and height will be measure with light clothing, without shoes. The BMI is calculate as 
the weight (kg) divided by the square height (m). The waist circumference (cm) will be measure 
midway between the lower edge of the lower rib and the upper part of the hip joint in the horizontal 
plane. Hips circumference (cm) will be measure on the widest part of the back in the horizontal 
plane. Body composition is analyzed using bioimpedance analysis (Tanita BC-418). Physical capacity 
will be measure as maximum oxygen uptake (VO2max) by indirect calorimetry (Jaeger Oxycon Pro). 
Indirect calorimetry is to be regard as a gold standard for measurement of maximum oxygen uptake. 
The test will be conduct as an individual custom protocol with gradual increase of incline and / or 
speed on treadmill (Woodway®) up to voluntary maximum fatigue. Maximum bone strength will be 
measure with a leg press device (OPS161 Interchangeable Leg Press). The test will be conduct as an 
individual adapted protocol with gradual loading until voluntary maximum bone strength is achieve.  
Data relating to the HRLK will be collect electronically through online survey form in the SurveyXact 
program, administered by the University of Agder. Patients are register with a project number and 
must answer questionnaires via Ipad or PC. Patients will sit at the outpatient clinic and have the 
opportunity to ask project staff for help if this should be necessary. Data is encrypt and register on a 
secured server, where project employee at the University of Agder can access the database through 
dual security routines. Project staff at the university cannot access the link key. This is stored at 

 
 
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Vestfold Hospital trust's research server. There is a separate data processing agreement between 
Rambøll Management and the University of Agder, which ensures data and data delivery.  
The following questionnaire must be answered; RAND 36-Item Short Form Health Survey (RAND-36), 
Impact on Weight Questionnaire (IWQOL-Lite), 3. Weight-Related Symptom Measure (WRSM), Power 
of Food Scale (PFS), Three Factor Eating Questionnaire (TFEQ - R21) and Binge Eating Scale (BES). All 
forms are translated to Norwegian. 
Informed consent 
We wish to obtain the written informed consent from all new patients who received day-based 
intensive lifestyle treatment for morbid obesity at Vestfold Hospital Trust. Data included in the 
project is already obtained in existing treatment program, and patients are not exposed to any 
deviations from the standard treatment at Vestfold Hospital Trust. Patients complete self-assessment 
forms for testing and exercise at the start of the treatment program. We want to emphasize that 
research will be conducted on unidentified data, and the results will not be linked to the individual 
patient. Patient information will be treated strictly confidential. Researchers will only use 
anonymized data. 
Statistical methods 
Intention to treat analyses will be performed in order to compare the effects of the treatment. 
Differences in outcome measures between patients will be assessed using analysis of covariance 
(ANCOVA), including baseline value of the dependent variable as covariate. Simple and multiple 
logistic regression will be implement to assess the changes of variables. 
Research group 
Project leader Jens Kristoffer Hertel, PhD - Morbid Obesity Centre, Vestfold Hospital Trust 
Jøran Hjelmesæth, MD, Professor - Morbid Obesity Centre, Vestfold Hospital Trust and University of 
Oslo, Jarle Berge, MSc (PhD- student) – Vestfold Hospital Trust and University of South East, Øyvind 
Støren, PhD, Associate Professor - University of South East, Milada Småstuen, PhD - Morbid Obesity 
Centre, Vestfold Hospital Trust and University of Oslo, Tor-Ivar Karlsen, PhD, Associate Professor – 
University og Agder and Morbid Obesity Centre, Vestfold Hospital Trust, Espen Gjevestad, PhD - 
Morbid Obesity Centre, Vestfold Hospital, Fredrik Andre Kolstad Hansen, MSc - Vestfold Hospital 
Trust, Simen Haugen, MD - Vestfold Hospital Trust, Linda Mathisen, research secretary - Morbid 
Obesity Centre, Vestfold Hospital 
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