ObesityEGONCT02311738
Exercise and Genes in Obese (EGO)
A study testing Training intensity intervention in people with Obesity, run by Jarle Berge at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Training intensity intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2015to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- Uncompensated heart failure
- Recent myocardial infarction or stroke (<½ years)
- Severe arrhythmia or heart failure
- Unstable angina pectoris
- Renal failure
- Pregnancy
Show all 10Show fewer
- Severe eating disorders
- Active substance abuse
- Being on a diet
- Taking medication known to affect appetite or metabolism (including thyroxin).
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Norway5 sites
Telemark University College
Bø, 3800
Vestfold University College
Horten, Raveien, 3184
University in Agder
Kristiansand, 4630
Vestfold Hospital Trust
Tønsberg, 3103
Norges Teknisk-naturvitenskapelig Universitet
Trondheim, 7491
United States1 site
Duke University School of Medicine
Durham, North Carolina, 27708
About this study
Official title: The Effect of Exercise and Genes on Energy Expenditure, Appetite and Quality of Life in Morbidly Obese Patients
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.
- Conditions
- Obesity
- Being tested
- Training intensity intervention
- Keywords
- Exercise and Genes in Obese (EGO)
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training intensity interventionOther
Also called EGO-HIT
High intensity training group describes the group performing high intensity exercise intervention. Moderate intensity training group describes the the group performing moderate exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| High intensity training group | Experimental | HIE will consist of the following:
1. 10 minute warm up at 70% of maximal heart rate.
2. 4 minute exercise intervals at 90-95% of maximal heart rate.
3. 4 minute interval bouts repeated 4 times.
4. Between each bouts there will be a 3 minute active recovery at 70% of maximal heart rate
5. After all four bouts are completed; 5 minute cool-down at 70% of maximal heart rate. Receives: Other: Training intensity intervention |
| Moderate intensity training group | Experimental | MIE will consist of the following:
1. 10 minute warm up at 50% of maximal heart rate.
2. 35 minutes exercise at 70% of maximal heart rate.
3. 4 minute cool-down at 50% of maximal heart rate. Receives: Other: Training intensity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure during physical activity
Energy expenditure (EE) during volitional activity will be measured with ergo-spirometry tests one week before the exercise intervention period starts, and repeated after each exercise period. Increasing the aerobic work capacity is supposed to give the same proportional increase in energy expenditure at any given maximal intensity.
Measured: 0, 8, 12 and 24 weeks
Secondary outcomes (14)
Resting metabolic rate
Resting metabolic rate will be measured with ergo-spirometry test one week before the exercise intervention period starts, and repeated after each exercise period. Increasing the aerobic work capacity is supposed to give increased resting metabolic rate.
Measured: 0, 8, 12 and 24 weeks
Cardiorespiratory fitness
Exercise may have a positive effect on cardiorespiratory fitness and will be measured with ergo-spirometry test
Measured: 0, 8, 12 and 24 weeks
Body mass index
Exercise may have a positive effect on weight change and will be calculated as weight in kilograms divided by height in meters squared
Measured: 0, 8, 12 and 24 weeks
Waist circumference
Exercise may have a positive effect on waist circumference and will be measured midway between the bottom edge of the lower rib and upper iliac crest in the horizontal plane.
Measured: 0, 8, 12 and 24 weeks
Fat mass and fat free mass
Exercise may have a positive effect on body composition and will be measured with the bioelectrical impedance analyser Tanita BC-418
Measured: 0, 8, 12 and 24 weeks
Appetite control
Patient self-appraisal of hunger and fullness will be assessed during fasting and after a standardised breakfast every 30 minutes (for a period of 3hours) using visual analogue scales.
Measured: 0,12 and 24 weeks
Genetic susceptibility
We hypothesize that inter-individual variability in adaptation/response to the two training regimens may also be due to genetic factors. We have designed a gene panel consisting of recognized and previously reported risk genes/variants with flanking sequences relevant for exercise (VO2max), participation in physical activity, obesity, diabetes, asthma and obesity related sub-phenotypes. The panel covers 1.2 Mb and includes 299 genes (exons with exon-intron junctions) and 1468 intronic and intergenic SNPs. Next-generation sequencing will be performed using a gene panel of selected genes/genetic regions by Illumina Nextera technology. The method involves enzymatic fragmentation of DNA and probe-based enrichment. The samples will be sequenced (paired-end, 2x100 bp) on a HiScanSQ. All wet lab methods (with other gene panels) are ISO15189 certified and in routine use at Unit for Medical Genetics at Telemark Hospital.
Measured: 0, 8, 12 and 24 weeks
Short form health survey (RAND-36)
RAND-36 is a 36-item measure of generic HRQOL consisting of eight additive subscales (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health) and two summary scores each based on four subscales (Physical Component Summary and Mental Component Summary). Scores on all subscales range from 0 to 100. Summary-scores will be norm-based, with mean (SD) 50 (10). Higher scores on all scales represent better HRQOL.
Measured: 0,12 and 24 weeks
Impact on Weight Questionnaire (IWQOL-Lite)
IWQOL-Lite is a 36-item measure of generic HRQOL consisting of eight additive subscales (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health) and two summary scores each based on four subscales (Physical Component Summary and Mental Component Summary). Scores on all subscales range from 0 to 100. Summary-scores will be norm-based, with mean (SD) 50 (10). Higher scores on all scales represent better HRQOL.
Measured: 0,12 and 24 weeks
Weight-Related Symptom Measure (WRSM)
WRSM is a 20-item measure for the presence and distress of 20 weight-related symptoms. The distress scores of the symptoms are reported on a six-point likert scale. Two summary scores are calculated; an additive score of presence of symptoms ranging from 1 to 20 and a symptom distress score for all symptoms. Symptom distress scores range from 0 to 100, with higher scores indicating a higher or worse total symptom distress.
Measured: 0,12 and 24 weeks
Power of Food scale (PFS)
PFS assess both the psychological impact and respondent's responsiveness to a food-abundant environment. This is a 15-item scale whose items pertain to three situations: food being readily available in the environment but not physically present, food is physically present, but not tasted, and food is first tasted but not already consumed. The three subscales is scored 0-100 with higher scores indicating greater eating problems.
Measured: 0,12 and 24 weeks
Binge Eating Scale (BES)
BES comprise 16 items assessing binge eating problems. Additive scores range between 0-46, with higher scores indicating greater problems. Cut-off scores have been established to determine binge severity, with "severe" represented by scores > 27, "moderate" by scores 18-26, and "mild-none" by scores < 17.
Measured: 0,12 and 24 weeks
Three Factor Eating Questionnaire (TFEQ -R21)
TFEQ -R21 is a 21-item questionnaire covering eating behavior domains: the cognitive restraint scale (6 items) assesses control over food intake and influence over body weight and body shape; the emotional eating scale (6 items) measures the propensity to overeat in relation to negative mood states, e.g., when feeling lonely, anxious, or depressed; and, the uncontrolled eating scale (9 items) assesses the tendency to lose control over eating when feeling hungry or when exposed to external stimuli
Measured: 0,12 and 24 weeks
Body weight change
Exercise may have a positive effect on weight change
Measured: 0, 8, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jarle Berge
- Sponsor type
- University, hospital or other
- Collaborators
- University of South-Eastern Norway, Vestfold University College, Duke University, University of Agder, Norwegian University of Science and Technology
- Responsible party
- Sponsor-investigator, Jarle Berge, Sykehuset i Vestfold HF
- Investigators
- Jøran Hjelmesæth, professor, Study director, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311738
- Sponsor's protocol ID
- EGO
- Acronym
- EGO
- Status last verified
- Sep 2021
- First submitted
- 26 Jun 2014
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35209911Berge 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.
PubMed 33491314
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise and Genes on Energy Expenditure, Appetite and Quality of Life in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT02311738
- Acronym / sponsor ID
- EGO / EGO
- Conditions
- Obesity
- Keywords
- Exercise and Genes in Obese (EGO)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jarle BergeUniversity, hospital or other
- Collaborators
- University of South-Eastern Norway, Vestfold University College, Duke University, University of Agder, Norwegian University of Science and Technology
- Study start
- Jan 2015 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity training group | Experimental | Other: Training intensity interventionHIE will consist of the following: 1. 10 minute warm up at 70% of maximal heart rate. 2. 4 minute exercise intervals at 90-95% of maximal heart rate. 3. 4 minute interval bouts repeated 4 times. 4. Between each bouts there will be a 3 minute active recovery at 70% of maximal heart rate 5. After all four bouts are completed; 5 minute cool-down at 70% of maximal heart rate. |
| Moderate intensity training group | Experimental | Other: Training intensity interventionMIE will consist of the following: 1. 10 minute warm up at 50% of maximal heart rate. 2. 35 minutes exercise at 70% of maximal heart rate. 3. 4 minute cool-down at 50% of maximal heart rate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (10 listed)
- Uncompensated heart failure
- Recent myocardial infarction or stroke (<½ years)
- Severe arrhythmia or heart failure
- Unstable angina pectoris
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training intensity interventionAlso: EGO-HITHigh intensity training group describes the group performing high intensity exercise intervention. Moderate intensity training group describes the the group performing moderate exercise intervention | Other | High intensity training group, Moderate intensity training group |
Primary outcome
Energy expenditure during physical activity
Time frame: 0, 8, 12 and 24 weeks
Energy expenditure (EE) during volitional activity will be measured with ergo-spirometry tests one week before the exercise intervention period starts, and repeated after each exercise period. Increasing the aerobic work capacity is supposed to give the same proportional increase in energy expenditure at any given maximal intensity.
14 secondary outcomes
Resting metabolic rate
Time frame: 0, 8, 12 and 24 weeks
Cardiorespiratory fitness
Time frame: 0, 8, 12 and 24 weeks
Body mass index
Time frame: 0, 8, 12 and 24 weeks
Waist circumference
Time frame: 0, 8, 12 and 24 weeks
Fat mass and fat free mass
Time frame: 0, 8, 12 and 24 weeks
Appetite control
Time frame: 0,12 and 24 weeks
Genetic susceptibility
Time frame: 0, 8, 12 and 24 weeks
Short form health survey (RAND-36)
Time frame: 0,12 and 24 weeks
Impact on Weight Questionnaire (IWQOL-Lite)
Time frame: 0,12 and 24 weeks
Weight-Related Symptom Measure (WRSM)
Time frame: 0,12 and 24 weeks
Power of Food scale (PFS)
Time frame: 0,12 and 24 weeks
Binge Eating Scale (BES)
Time frame: 0,12 and 24 weeks
Three Factor Eating Questionnaire (TFEQ -R21)
Time frame: 0,12 and 24 weeks
Body weight change
Time frame: 0, 8, 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 35209911Berge 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.
- Derived from this study: PubMed 33491314Berge 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jøran Hjelmesæth, professor study director
The Hospital of Vestfold
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training intensity intervention in people with Obesity, run by Jarle Berge at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure during physical activity (time frame: 0, 8, 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02311738, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.