Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity
Conditions: Physical Capacity
Sponsor: Sykehuset i Vestfold HF

 
 
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Lifestyle intervention and physical capacity in patients with morbid 
Obesity (LEICO) 
 
05.06.2018 
Approved by Regional committees for medical and health research ethics, Norwegian. ID 
2016/1414 
 

 
 
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Background  
Physical inactivity provides reduce years of life, physical capacity, physical strength, quality of life, 
energy expenditure, sleep quality, appetite regulation, and increased degree of dysfunctional eating 
behavior (1, 2). Increased physical activity prevent overweight and help reduce weight (3, 4) 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 (5, 
6). Physical capacity may also be important for weight stabilization after weight loss (1, 7). A 
combination of physical activity and calorie reduction is therefore appropriate to decrease body 
weight (8). One of the few studies that mapped physical capacity after a lifestyle treatment found no 
significant change in body weight or physical capacity (9). However, the researchers found greatest 
weight loss in patients with the greatest progress in physical capacity. Anyway, it is not clear how 
physical activity and capacity affect the loss or maintenance of body weight in patients with morbid 
obesity. 
In summary, it is still uncertainty about which is the most effective lifestyle treatment to reducing 
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 can affect the effect of lifestyle treatment offered to 
patients in the health service. 
Research questions 
We want to investigate whether patients with good physical capacity (maximal oxygen uptake) at 
start of treatment and / or after 12 weeks of intensive exercise, have a greater weight loss 1 year 
after start of treatment than patients with low physical capacity. 
This issue will be illustrate by the following hypotheses: 
1. Physical capacity before start of treatment is associated with weight loss at 12-weeks and 1-
year follow-up (FU) 
 
2. The mean twelve-week change in physical capacity is associated with weight loss at 1- year 
FU. 
Data   
Standard treatment at Vestfold Hospital Trust, the following data is obtained at baseline, 12-weeks 
and 1-year follow up: body weight, hip circumference, waist circumference, body composition, body 
mass index, height, age, sex and physical capacity (maximal oxygen uptake). In this study, we wish to 
use the collected data to research the hypotheses above. 
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. 

 
 
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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.  
Informed consent 
We want to send out information to 200 patients who have participated on a day-to-day intensive 
lifestyle treatment for morbid obesity at Vestfold Hospital Trust (from November 2013 to May 2016), 
they actively contact if they not want the above information to be used in the research project. 
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 
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- fellow) – 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 
 
Kilder 
1. 
Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Asumi M, et al. Cardiorespiratory fitness as a 
quantitative predictor of all-cause mortality and cardiovascular events in healthy men and women: a 
meta-analysis. Jama. 2009;301(19):2024-35. 
2. 
Karlsen TI, Sohagen M, Hjelmesaeth J. Predictors of weight loss after an intensive lifestyle 
intervention program in obese patients: a 1-year prospective cohort study. Health and quality of life 
outcomes. 2013;11:165. 
3. 
Aadland E, Anderssen SA. [The effect of physical activity on weight loss]. Tidsskr Nor 
Laegeforen. 2013;133(1):37-40. 
4. 
McCrady-Spitzer SK, Levine JA. Nonexercise activity thermogenesis: a way forward to treat 
the worldwide obesity epidemic. Surg Obes Relat Dis. 2012;8(5):501-6. 
5. 
Miller WM, Spring TJ, Zalesin KC, Kaeding KR, Nori Janosz KE, McCullough PA, et al. Lower 
than predicted resting metabolic rate is associated with severely impaired cardiorespiratory fitness in 
obese individuals. Obesity (Silver Spring, Md). 2012;20(3):505-11. 

 
 
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6. 
Whyte LJ, Gill JM, Cathcart AJ. Effect of 2 weeks of sprint interval training on health-related 
outcomes in sedentary overweight/obese men. Metabolism. 2010;59(10):1421-8. 
7. 
Wadden TA, Webb VL, Moran CH, Bailer BA. Lifestyle modification for obesity: new 
developments in diet, physical activity, and behavior therapy. Circulation. 2012;125(9):1157-70. 
8. 
Clark JE. Erratum to: Diet, exercise or diet with exercise: comparing the effectiveness of 
treatment options for weight-loss and changes in fitness for adults (18-65 years old) who are overfat, 
or obese; systematic review and meta-analysis. Journal of diabetes and metabolic disorders. 
2015;14:73. 
9. 
Jakicic JM, Marcus BH, Lang W, Janney C. Effect of exercise on 24-month weight loss 
maintenance in overweight women. Arch Intern Med. 2008;168(14):1550-9; discussion 9-60.