- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04029532
Factors Associated With Obesity in Adult Women: Respiratory Exchange Ratio, Heart Rate Variation and Body Image
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Zhongzheng
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Taipei, Zhongzheng, Taiwan, 100
- National Taiwan University, College of Medicine, Department of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 20-50 years old, premenopausal
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-overweight/obese & normal weight
Body mass index (BMI) < 24.0 kg/m^2
|
Ask participants to supine on bed, using a ventilator hood cover upon their head.
Measure respiratory exchange ratio for 15 minutes.
Ask participants to supine on bed for 10 minutes, connect electrodes on their right wrist.
Measure heart rate variability for 5 minutes.
Ask participants to supine on bed for 10 minutes, connect electrodes on their right wrist and right foot.
Measure body composition.
Fill in questionnaire (Three-Factor Eating Questionnaire, revised 18-item, TFEQ-18).
Fill in questionnaire (Seven-days Physical Activity Recall, 7-d PAR).
Fill in questionnaire (Mongomery-Asberg Depression Rating Scale, MADRS).
Fill in questionnaire (multi-directional self-body relationship questionnaire (MBSRQ), figure rating scale (FRS)).
|
|
Overweight and obese
Body mass index (BMI) >= 24.0 kg/m^2
|
Ask participants to supine on bed, using a ventilator hood cover upon their head.
Measure respiratory exchange ratio for 15 minutes.
Ask participants to supine on bed for 10 minutes, connect electrodes on their right wrist.
Measure heart rate variability for 5 minutes.
Ask participants to supine on bed for 10 minutes, connect electrodes on their right wrist and right foot.
Measure body composition.
Fill in questionnaire (Three-Factor Eating Questionnaire, revised 18-item, TFEQ-18).
Fill in questionnaire (Seven-days Physical Activity Recall, 7-d PAR).
Fill in questionnaire (Mongomery-Asberg Depression Rating Scale, MADRS).
Fill in questionnaire (multi-directional self-body relationship questionnaire (MBSRQ), figure rating scale (FRS)).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory exchange ratio (RER)
Time Frame: After filling in all questionnaires, lasting 15 minutes.
|
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. |
After filling in all questionnaires, lasting 15 minutes.
|
|
Heart rate variability (HRV)
Time Frame: After measuring respiratory exchange ratio, lasting 15 minutes.
|
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. |
After measuring respiratory exchange ratio, lasting 15 minutes.
|
|
Body image
Time Frame: After filling in basic data questionnaire, lasting 10 minutes.
|
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.
|
After filling in basic data questionnaire, lasting 10 minutes.
|
|
Body image (evaluative component)
Time Frame: After filling in multi-directional self-body relationship questionnaire (MBSRQ), lasting 5 minutes.
|
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.
|
After filling in multi-directional self-body relationship questionnaire (MBSRQ), lasting 5 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body fat percentage
Time Frame: After measuring heart rate variability, lasting 5 minutes.
|
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.
|
After measuring heart rate variability, lasting 5 minutes.
|
|
Physical activity
Time Frame: After filling in body image questionnaire, lasting 5 minutes.
|
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.
|
After filling in body image questionnaire, lasting 5 minutes.
|
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Eating behavior
Time Frame: After filling in physical activity questionnaire, lasting 5 minutes.
|
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.
|
After filling in physical activity questionnaire, lasting 5 minutes.
|
|
Depression
Time Frame: After filling in eating behavior questionnaire, lasting 5 minutes.
|
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.
|
After filling in eating behavior questionnaire, lasting 5 minutes.
|
Collaborators and Investigators
Publications and helpful links
General Publications
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- Maust D, Cristancho M, Gray L, Rushing S, Tjoa C, Thase ME. Psychiatric rating scales. Handb Clin Neurol. 2012;106:227-37. doi: 10.1016/B978-0-444-52002-9.00013-9. No abstract available.
- Paiva-Medeiros PF, Duarte-Guerra LS, Santo MA, Lotufo-Neto F, Wang YP. Psychometric Properties of the Montgomery-Asberg Depression Rating Scale in Severely Obese Patients. Span J Psychol. 2015 Sep 14;18:E69. doi: 10.1017/sjp.2015.072.
- Schaefer LM, Harriger JA, Heinberg LJ, Soderberg T, Kevin Thompson J. Development and validation of the sociocultural attitudes towards appearance questionnaire-4-revised (SATAQ-4R). Int J Eat Disord. 2017 Feb;50(2):104-117. doi: 10.1002/eat.22590. Epub 2016 Aug 19.
- Rosen JC, Jones A, Ramirez E, Waxman S. Body Shape Questionnaire: studies of validity and reliability. Int J Eat Disord. 1996 Nov;20(3):315-9. doi: 10.1002/(SICI)1098-108X(199611)20:33.0.CO;2-Z.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201901140RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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