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Exercise and Genes in Obese (EGO) (EGO)

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ClinicalTrials.gov Identifier: NCT02311738
Recruitment Status : Active, not recruiting
First Posted : December 8, 2014
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
University of South-Eastern Norway
Vestfold University College
Duke University
University of Agder
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Jarle Berge, Sykehuset i Vestfold HF

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.


Condition or disease Intervention/treatment Phase
Obesity Other: Training intensity intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Exercise and Genes on Energy Expenditure, Appetite and Quality of Life in Morbidly Obese Patients
Actual Study Start Date : January 2015
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High intensity training group

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.
Other: Training intensity intervention
High intensity training group describes the group performing high intensity exercise intervention. Moderate intensity training group describes the the group performing moderate exercise intervention
Other Name: EGO-HIT

Experimental: Moderate intensity training group

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.
Other: Training intensity intervention
High intensity training group describes the group performing high intensity exercise intervention. Moderate intensity training group describes the the group performing moderate exercise intervention
Other Name: EGO-HIT




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Resting metabolic rate [ Time Frame: 0, 8, 12 and 24 weeks ]
    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.

  2. Cardiorespiratory fitness [ Time Frame: 0, 8, 12 and 24 weeks ]
    Exercise may have a positive effect on cardiorespiratory fitness and will be measured with ergo-spirometry test

  3. Body mass index [ Time Frame: 0, 8, 12 and 24 weeks ]
    Exercise may have a positive effect on weight change and will be calculated as weight in kilograms divided by height in meters squared

  4. Waist circumference [ Time Frame: 0, 8, 12 and 24 weeks ]
    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.

  5. Fat mass and fat free mass [ Time Frame: 0, 8, 12 and 24 weeks ]
    Exercise may have a positive effect on body composition and will be measured with the bioelectrical impedance analyser Tanita BC-418

  6. Appetite control [ Time Frame: 0,12 and 24 weeks ]
    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.

  7. Genetic susceptibility [ Time Frame: 0, 8, 12 and 24 weeks ]
    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.

  8. Short form health survey (RAND-36) [ Time Frame: 0,12 and 24 weeks ]
    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.

  9. Impact on Weight Questionnaire (IWQOL-Lite) [ Time Frame: 0,12 and 24 weeks ]
    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.

  10. Weight-Related Symptom Measure (WRSM) [ Time Frame: 0,12 and 24 weeks ]
    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.

  11. Power of Food scale (PFS) [ Time Frame: 0,12 and 24 weeks ]
    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.

  12. Binge Eating Scale (BES) [ Time Frame: 0,12 and 24 weeks ]
    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.

  13. Three Factor Eating Questionnaire (TFEQ -R21) [ Time Frame: 0,12 and 24 weeks ]
    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

  14. Body weight change [ Time Frame: 0, 8, 12 and 24 weeks ]
    Exercise may have a positive effect on weight change


Other Outcome Measures:
  1. Substrate oxidation [ Time Frame: 0, 8, 12 and 24 weeks ]
    Exercise may have a positive effect on substrate oxidation (for example fat oxidation) and will be measured with ergo-spirometry tests

  2. Hip circumference [ Time Frame: 0, 8, 12 and 24 weeks ]
    Exercise may have a positive effect on hip circumference and will be measured on the widest part of the hip in the horizontal plane.

  3. Daily activity [ Time Frame: 0, 17 and 24 weeks ]
    Exercise can affect daily activity. Measurements of 24-hour activity during free living will be performed with accelerometer (ActiGraph wGT3x-BT, Pensacola, FL, USA). The 24-hour activity expressed as daily activity counts per minute (Vector magnitude, CPM). The registrations will last for 24 hours during 7 days including the weekend.

  4. Total energy intake [ Time Frame: 0 and 24 weeks ]
    Exercise can affect total energy intake. A 180 items food frequency questionnaire developed in Norway and validated to assess habitual diet among men and women, was will be used. The dietary data will be entered by scanning, using the teleform program (10.0) (Datascan, Oslo, Norway). Daily intake of foods, energy and nutrients will be calculated using software (KBS version 7.3 2017; developed at the institute of Basic Medical Sciences, University of Oslo). The software is based on Norwegian food composition table (Norwegian Food Composition Database 2017. Norwegian Food Safety Authority)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311738


Locations
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United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27708
Norway
Vestfold University College
Horten, Raveien, Norway, 3184
Telemark University College
Bø, Norway, 3800
University in Agder
Kristiansand, Norway, 4630
Norges Teknisk-naturvitenskapelig Universitet
Trondheim, Norway, 7491
Vestfold Hospital Trust
Tønsberg, Norway, 3103
Sponsors and Collaborators
Jarle Berge
University of South-Eastern Norway
Vestfold University College
Duke University
University of Agder
Norwegian University of Science and Technology
Investigators
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Study Director: Jøran Hjelmesæth, professor The Hospital of Vestfold
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Responsible Party: Jarle Berge, PhD-Fellow, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT02311738    
Other Study ID Numbers: EGO
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Keywords provided by Jarle Berge, Sykehuset i Vestfold HF:
Exercise and Genes in Obese (EGO)