Clinical trial NCT04029532: Factors Associated With Obesity in Adult Women: Respiratory Exchange Ratio, Heart Rate Variation and Body Image
Official title: Factors Associated With Obesity in Adult Women: Respiratory Exchange Ratio, Heart Rate Variation and Body Image
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Respiratory exchange ratio
Body image
Heart rate variability
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 121
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Asian, mainly living in Taiwan

Brief 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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory exchange ratio (RER)
timeFrame: After filling in all questionnaires, lasting 15 minutes.
measure: Heart rate variability (HRV)
timeFrame: After measuring respiratory exchange ratio, lasting 15 minutes.
measure: Body image
timeFrame: After filling in basic data questionnaire, lasting 10 minutes.
measure: Body image (evaluative component)
timeFrame: After filling in multi-directional self-body relationship questionnaire (MBSRQ), lasting 5 minutes.
Secondary outcomes:
measure: Body fat percentage
timeFrame: After measuring heart rate variability, lasting 5 minutes.
measure: Physical activity
timeFrame: After filling in body image questionnaire, lasting 5 minutes.
measure: Eating behavior
timeFrame: After filling in physical activity questionnaire, lasting 5 minutes.
measure: Depression
timeFrame: After filling in eating behavior questionnaire, lasting 5 minutes.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University, College of Medicine, Department of Physical Therapy
state: Zhongzheng
Study officials:
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