Clinical trial NCT02311738: Exercise and Genes in Obese (EGO)
Official title: The Effect of Exercise and Genes on Energy Expenditure, Appetite and Quality of Life in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Exercise and Genes in Obese (EGO)
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: University of South-Eastern Norway
name: Vestfold University College
name: Duke University
name: University of Agder
name: Norwegian University of Science and Technology
First posted: 2014-12-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Regular exercise has several positive health effects including increased physical fitness and muscle mass. It is well known that increased muscle mass is associated with increased resting energy expenditure which may facilitate weight loss and maintenance. Previous studies have, however, failed to show any consistent association between the intensity of physical exercise and energy expenditure, or relate the variance in these adaptations to genetic variability. Whether high-intensity exercise (HIE) is associated with improved health related quality of life in severely obese patients remains unknown.

This PhD-project is based on a planned randomised controlled study including 50 or more treatment seeking morbidly obese patients who will be randomised to either a 24 week moderate-intensity exercise (MIE) programme or a 24 week high-intensity exercise (HIE) programme. The investigators main hypothesis is that patients randomised to the HIE-program will achieve higher energy expenditure during rest and physical activity after treatment than those allocated to the MIE-programme. In addition, the investigators hypothesise that the HIE-group will achieve a better health related quality of life than the MIE-group after treatment. The investigators also hypothesize that inter-individual variability in adaptation to the two training regimens may be due to genetic factors. If the investigators hypotheses are confirmed, this project might have beneficial clinical implications for future obesity treatment strategies.


Eligibility criteria: Inclusion Criteria:

* Treatment seeking weight stable morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the outpatient Obesity Center, Vestfold Hospital Trust, will be informed about this RCT .

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
* Being on a diet
* Taking medication known to affect appetite or metabolism (including thyroxin).

Primary outcomes:
measure: Energy expenditure during physical activity
timeFrame: 0, 8, 12 and 24 weeks
Secondary outcomes:
measure: Resting metabolic rate
timeFrame: 0, 8, 12 and 24 weeks
measure: Cardiorespiratory fitness
timeFrame: 0, 8, 12 and 24 weeks
measure: Body mass index
timeFrame: 0, 8, 12 and 24 weeks
measure: Waist circumference
timeFrame: 0, 8, 12 and 24 weeks
measure: Fat mass and fat free mass
timeFrame: 0, 8, 12 and 24 weeks
measure: Appetite control
timeFrame: 0,12 and 24 weeks
measure: Genetic susceptibility
timeFrame: 0, 8, 12 and 24 weeks
measure: Short form health survey (RAND-36)
timeFrame: 0,12 and 24 weeks
measure: Impact on Weight Questionnaire (IWQOL-Lite)
timeFrame: 0,12 and 24 weeks
measure: Weight-Related Symptom Measure (WRSM)
timeFrame: 0,12 and 24 weeks
measure: Power of Food scale (PFS)
timeFrame: 0,12 and 24 weeks
measure: Binge Eating Scale (BES)
timeFrame: 0,12 and 24 weeks
measure: Three Factor Eating Questionnaire (TFEQ -R21)
timeFrame: 0,12 and 24 weeks
measure: Body weight change
timeFrame: 0, 8, 12 and 24 weeks
Other outcomes:
measure: Substrate oxidation
timeFrame: 0, 8, 12 and 24 weeks
measure: Hip circumference
timeFrame: 0, 8, 12 and 24 weeks
measure: Daily activity
timeFrame: 0, 17 and 24 weeks
measure: Total energy intake
timeFrame: 0 and 24 weeks
Locations:
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Horten
country: Norway
facility: Vestfold University College
state: Raveien
city: Bø
country: Norway
facility: Telemark University College
city: Kristiansand
country: Norway
facility: University in Agder
city: Trondheim
country: Norway
facility: Norges Teknisk-naturvitenskapelig Universitet
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust
Study officials:
affiliation: The Hospital of Vestfold
name: Jøran Hjelmesæth, professor
role: STUDY_DIRECTOR
References:
citation: Berge J, Hjelmesaeth J, Kolotkin RL, Storen O, Bratland-Sanda S, Hertel JK, Gjevestad E, Smastuen MC, Helgerud J, Bernklev T. Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial. Health Qual Life Outcomes. 2022 Feb 24;20(1):34. doi: 10.1186/s12955-022-01940-y.
citation: Berge J, Hjelmesaeth J, Hertel JK, Gjevestad E, Smastuen MC, Johnson LK, Martins C, Andersen E, Helgerud J, Storen O. Effect of Aerobic Exercise Intensity on Energy Expenditure and Weight Loss in Severe Obesity-A Randomized Controlled Trial. Obesity (Silver Spring). 2021 Feb;29(2):359-369. doi: 10.1002/oby.23078.