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ObesityNCT04029532

Factors Associated With Obesity in Adult Women: Respiratory Exchange Ratio, Heart Rate Variation and Body Image

An observational study of Obesity, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prevalence of obesity all over the world has increased year by year, and how to effectively prevent and treat obesity has become an important health care issue. Many adjustable and nonadjustable causes of obesity have been proposed, such as unbalanced eating habits, lack of physical activity, psychological… Read more about this study

Who is it for?
Ages 20 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Respiratory exchange ratio, Heart rate variability and Body composition
How many people
121 participants
Where
1 siteTaiwan
Study dates
1 Apr 2019to 14 Jan 2020
Phase
Observational
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 20 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Asian, mainly living in Taiwan

Who may be able to join

  • 20-50 years old, premenopausal

Who cannot join

  • Taking medications that affect weight or hormones
  • Fluctuation of weight exceeds 2 kg within 3 months before the enrolled in study
  • Any condition that causes the subject fail to complete the test paper, such as: cognitive problems
  • Diagnosed with mental illness
  • Pregnancy or menopause

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University, College of Medicine, Department of Physical Therapy

    Taipei, Zhongzheng, 100

Other trials in Taiwan

About this study

The prevalence of obesity all over the world has increased year by year, and how to effectively prevent and treat obesity has become an important health care issue. Many adjustable and nonadjustable causes of obesity have been proposed, such as unbalanced eating habits, lack of physical activity, psychological factors, and genes. The practice guidelines recommended lifestyle modification interventions which include diet control combined with regular exercise as the core treatment for obesity, but the effects on different ethnic groups are not ideal. In order to provide more choices for future weight loss intervention, it would be important to find out more risk factors for obesity. Previous studies have shown that lower sympathetic activity assessed by heart rate variability was related to obesity; obese men have higher respiratory exchange rates which might indicate they are more likely to use carbohydrates as a source of energy, and therefore, fat cannot be effectively consumed and led to an accumulation in the body. Furthermore, previous studies showed that Asians are less satisfied with their body image than other races, and women are more dissatisfied than men. Poor body image will lead to a series of effects, such as changes in eating habits, hormonal changes, depression, etc., eventually forming a vicious circle of obesity. However, most aforementioned Asians in these studies are immigrants living in overseas areas such as the Americas, and cannot fully represent the ethnic groups in Asia. Therefore, the purpose of this study are (1) to investigate the physiological and psychological factors influence obesity in adult women, including respiratory exchange rate, heart rate variability, and body image, and (2) to examine the correlations among these risk factors and different degree of obesity.

Read the detailed description

Methods: This is a cross-sectional design study. Subjects were recruited from Taipei city. Inclusion criteria are women aged between 20 and 50 years old and have willing to participate to this study. Subjects will be excluded as follows: (1) taking medications that affect weight or hormones; (2) fluctuation of weight exceeds 2 kg within 3 months before the enrolled in study; (3) any condition that causes the subject fail to complete the test paper, such as: cognitive problems; (4) diagnosed with mental illness; (5) pregnancy or menopause. The assessments include: obesity-related indicators (height, weight, waist and hip circumference, percentage of body fat), respiratory exchange ratio, heart rate variability, body image (multi-directional self-body relationship questionnaire (MBSRQ), figure rating scale (FRS)), physical activity (Seven-days Physical Activity Recall, 7-d PAR), eating behavior (Three-Factor Eating Questionnaire, revised 18-item, TFEQ-18), and depression (Mongomery-Asberg Depression Rating Scale, MADRS). Statistical analysis will be performed by using SPSS version 18 (SPSS Inc, Chicago: SPSS Inc.), and significant level would be set at 0.05. Analysis of variance (ANOVA) will be used to examine the differences of all measured variables among different degrees of obesity groups. In addition, we will use multiple linear regression analysis to examine whether overweight and obesity are significantly related to respiratory exchange rate, heart rate variability and body image.

Conditions
Obesity
Being tested
Respiratory exchange ratio, Heart rate variability, Body composition, Eating behavior, Physical activity recall
Keywords
Respiratory exchange ratio, Body image, Heart rate variability
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Respiratory exchange ratioDevice

    Ask participants to supine on bed, using a ventilator hood cover upon their head. Measure respiratory exchange ratio for 15 minutes.

  • Heart rate variabilityDevice

    Ask participants to supine on bed for 10 minutes, connect electrodes on their right wrist. Measure heart rate variability for 5 minutes.

  • Body compositionDevice

    Ask participants to supine on bed for 10 minutes, connect electrodes on their right wrist and right foot. Measure body composition.

  • Eating behaviorBehavioural

    Fill in questionnaire (Three-Factor Eating Questionnaire, revised 18-item, TFEQ-18).

  • Physical activity recallBehavioural

    Fill in questionnaire (Seven-days Physical Activity Recall, 7-d PAR).

  • DepressionBehavioural

    Fill in questionnaire (Mongomery-Asberg Depression Rating Scale, MADRS).

  • Body imageBehavioural

    Fill in questionnaire (multi-directional self-body relationship questionnaire (MBSRQ), figure rating scale (FRS)).

Study groups in NCT04029532
Study groupRoleWhat they receive
Non-overweight/obese & normal weightBody mass index (BMI) < 24.0 kg/m^2
Receives: Device: Respiratory exchange ratio; Device: Heart rate variability; Device: Body composition; Behavioral: Eating behavior; Behavioral: Physical activity recall; Behavioral: Depression; Behavioral: Body image
Overweight and obeseBody mass index (BMI) >= 24.0 kg/m^2
Receives: Device: Respiratory exchange ratio; Device: Heart rate variability; Device: Body composition; Behavioral: Eating behavior; Behavioral: Physical activity recall; Behavioral: Depression; Behavioral: Body image

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory exchange ratio (RER)

    Ask participants to supine on bed, using a ventilator hood cover upon their head. Measure respiratory exchange ratio for 15 minutes.

    Device used: Vmax® Encore Metabolic Cart, Carefusion Corporation, Yorba Linda, California (CA).

    Normal range: 0.7-1.0, greater value indicates more carbohydrates oxidation, while smaller value indicates more fat oxidation.

    Measured: After filling in all questionnaires, lasting 15 minutes.

  2. Heart rate variability (HRV)

    Ask participants to supine on bed for 10 minutes, connect electrodes on their right wrist. Measure heart rate variability for 5 minutes. Device used: SS1C, Enjoy Research Inc., Taiwan.

    High frequency (HF): greater value indicates active parasympathetic activity. Low frequency-high frequency ratio (LF/HF): greater value indicates active sympathetic activity.

    Measured: After measuring respiratory exchange ratio, lasting 15 minutes.

  3. Body image

    Fill in questionnaire (multi-directional self-body relationship questionnaire (MBSRQ)). There are 69 questions, each question scores 1-5 points. Sum up all points, greater value indicates better body image.

    Measured: After filling in basic data questionnaire, lasting 10 minutes.

  4. Body image (evaluative component)

    Figure rating scale (FRS) is used. Nine figures of women (from lean to obese) is provided, participants are asked to choose which figure fits her present and ideal appearance the most. Scoring 1-9 points, greater value indicates poorer body image.

    Measured: After filling in multi-directional self-body relationship questionnaire (MBSRQ), lasting 5 minutes.

Secondary outcomes (4)

  1. Body fat percentage

    Ask participants to supine on bed for 10 minutes, connect electrodes on their right wrist and right foot. Measure body fat percentage. Device used: Maltron BioScan 920-2. Greater value indicates higher body fat percentage.

    Measured: After measuring heart rate variability, lasting 5 minutes.

  2. Physical activity

    Fill in questionnaire (Seven-days Physical Activity Recall, 7-d PAR). Participants are asked to recall average time spent in a week on sleeping and activities of different intensities (Unit: metabolic equivalent of tasks (METs)). Sleeping, mild activity, moderate activity, vigorous activity, very vigorous activity are calculated as 1, 1.5, 4, 6, 10 METs respectively. Sum up all METs, divided by 7, we can obtain average daily energy expenditure. Greater value indicates more physical activity done.

    Measured: After filling in body image questionnaire, lasting 5 minutes.

  3. Eating behavior

    Fill in questionnaire (Three-Factor Eating Questionnaire, revised 18-item, TFEQ-18). This questionnaire includes 18 questions, scoring 1-4 points, except question 18 (1-8 points). Sum up all points, greater value indicates better eating behavior.

    Measured: After filling in physical activity questionnaire, lasting 5 minutes.

  4. Depression

    Fill in questionnaire (Mongomery-Asberg Depression Rating Scale, MADRS). This questionnaire includes 10 questions, scoring 0-6 points. Sum up all points, greater value indicates more depressed.

    Measured: After filling in eating behavior questionnaire, lasting 5 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2019
  2. Study start1 Apr 2019
  3. Primary completion26 Oct 2019
  4. Study completion14 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04029532
Sponsor's protocol ID
201901140RINA
Status last verified
Nov 2019
First submitted
15 Apr 2019
Last updated
12 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We will respect the participants' willingness.

Publications

  • Hruby A, Hu FB. The Epidemiology of Obesity: A Big Picture. Pharmacoeconomics. 2015 Jul;33(7):673-89. doi: 10.1007/s40273-014-0243-x.

    PubMed 25471927

  • Acosta A, Streett S, Kroh MD, Cheskin LJ, Saunders KH, Kurian M, Schofield M, Barlow SE, Aronne L. White Paper AGA: POWER - Practice Guide on Obesity and Weight Management, Education, and Resources. Clin Gastroenterol Hepatol. 2017 May;15(5):631-649.e10. doi: 10.1016/j.cgh.2016.10.023. Epub 2017 Feb 27.

    PubMed 28242319

  • Ryan DH, Kahan S. Guideline Recommendations for Obesity Management. Med Clin North Am. 2018 Jan;102(1):49-63. doi: 10.1016/j.mcna.2017.08.006.

    PubMed 29156187

  • Ramos-Jimenez A, Hernandez-Torres RP, Torres-Duran PV, Romero-Gonzalez J, Mascher D, Posadas-Romero C, Juarez-Oropeza MA. The Respiratory Exchange Ratio is Associated with Fitness Indicators Both in Trained and Untrained Men: A Possible Application for People with Reduced Exercise Tolerance. Clin Med Circ Respirat Pulm Med. 2008 Feb 1;2:1-9. doi: 10.4137/ccrpm.s449.

    PubMed 21157516

  • Weng KP, Ho TY, Ou SF, Lin CC, Hsieh KS. Heart rate variability analysis. Taiwan Medical Journal. 2009;52:290-3.

  • Wang ML, Lin PL, Huang CH, Huang HH. Decreased Parasympathetic Activity of Heart Rate Variability During Anticipation of Night Duty in Anesthesiology Residents. Anesth Analg. 2018 Mar;126(3):1013-1018. doi: 10.1213/ANE.0000000000002439.

    PubMed 29200073

  • Messina G, De Luca V, Viggiano A, Ascione A, Iannaccone T, Chieffi S, Monda M. Autonomic nervous system in the control of energy balance and body weight: personal contributions. Neurol Res Int. 2013;2013:639280. doi: 10.1155/2013/639280. Epub 2013 Apr 11.

    PubMed 23691314

  • Tonhajzerova I, Javorka M, Trunkvalterova Z, Chroma O, Javorkova J, Lazarova Z, Ciljakova M, Javorka K. Cardio-respiratory interaction and autonomic dysfunction in obesity. J Physiol Pharmacol. 2008 Dec;59 Suppl 6:709-18.

    PubMed 19218698

  • Rodriguez-Colon SM, Bixler EO, Li X, Vgontzas AN, Liao D. Obesity is associated with impaired cardiac autonomic modulation in children. Int J Pediatr Obes. 2011 Apr;6(2):128-34. doi: 10.3109/17477166.2010.490265. Epub 2010 Oct 4.

    PubMed 20919806

  • Karason K, Molgaard H, Wikstrand J, Sjostrom L. Heart rate variability in obesity and the effect of weight loss. Am J Cardiol. 1999 Apr 15;83(8):1242-7. doi: 10.1016/s0002-9149(99)00066-1.

    PubMed 10215292

  • Yadav RL, Yadav PK, Yadav LK, Agrawal K, Sah SK, Islam MN. Association between obesity and heart rate variability indices: an intuition toward cardiac autonomic alteration - a risk of CVD. Diabetes Metab Syndr Obes. 2017 Feb 17;10:57-64. doi: 10.2147/DMSO.S123935. eCollection 2017.

    PubMed 28255249

  • Sudarsana U, Shrestha S, Kumar P. Comparative analysis of autonomic function tests in normotensive premenopausal and postmenopausal women. Int J Med Res Prof. 2017;3;234-9.

  • Monda M, Messina G, Vicidomini C, Viggiano A, Mangoni C, De Luca B. Activity of autonomic nervous system is related to body weight in pre-menopausal, but not in post-menopausal women. Nutr Neurosci. 2006 Jun-Aug;9(3-4):141-5. doi: 10.1080/10284150600903552.

    PubMed 17176636

  • Cash TF, Morrow JA, Hrabosky JI, Perry AA. How has body image changed? A cross-sectional investigation of college women and men from 1983 to 2001. J Consult Clin Psychol. 2004 Dec;72(6):1081-1089. doi: 10.1037/0022-006X.72.6.1081.

    PubMed 15612854

  • Schwartz MB, Brownell KD. Obesity and body image. Body Image. 2004 Jan;1(1):43-56. doi: 10.1016/S1740-1445(03)00007-X.

    PubMed 18089140

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by National Taiwan University Hospital at 1 site in Taiwan.

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 5 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: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Respiratory exchange ratio (RER) (time frame: After filling in all questionnaires, lasting 15 minutes.). The study lists 4 primary outcomes in all. 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 NCT04029532, which also lists 80 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 12 Aug 2020.

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