Uno studio su un intervento sullo stile di vita basato sullo yoga rispetto al solo intervento dietetico sui fattori di rischio cardiometabolico nelle persone con prediabete

I NTRODUCTION

Prediabetes is a state of intermediate hyperglycemia where glucose levels in the blood are above the normal range (100–125 mg/dl) but below the diabetic range (>125 mg/dl) and most diabetic subjects manifest the state of prediabetes before the onset.[ ]

The American Diabetes Association states that prediabetes is diagnosed with fasting plasma glucose (FPG) levels of 100–125 mg/dL, HbA1c between 5.7% and 6.4%, or an elevated plasma glucose level following an oral glucose tolerance test (OGTT) of 140–199 mg/dL.[ ] On the other hand, diagnoses of diabetes using FPG, OGTT, and HbA1C are ≥7.0 mmol/L (126 mg/dl), 11.1 mmol/L (200 mg/dl), and 6.5%, respectively.[ ]

The overall current prevalence of prediabetes and diabetes in India is 10.3% and 7.3%, respectively.[ ] Previous findings of a study suggest that almost 60% of prediabetes with impaired fasting glucose were turned into diabetics in 10-year follow-ups.[ ] Prediabetes is presented as a metabolic state that predisposes persons to a greater risk of diabetes progression in the future.[ ] Increased blood glucose levels, insulin resistance, and cardiovascular disease are associated with subclinical and chronic inflammation as evidenced by raised inflammatory markers and cytokine levels.[ ] Previous studies show that lifestyle intervention programs promoting healthy diets, physical activity, and modest body weight reductions can prevent or delay the onset of diabetes among high-risk populations.[ ]

Lifestyle interventions such as dietary and yoga intervention are ancient practices that is said to benefit all components of health and may prove to be helpful in nonpharmacological interventions to inhibit the progression of prediabetes to type 2 diabetes (T2D) and related complications.[ ] Yoga-based lifestyle intervention is an emerging integrative healthcare practice comprised of asanas (physical exercises), pranayama (breathing techniques), and meditation for short- and long-term regulation of prediabetes, diabetes, and its complications.[ ] Studies have also shown that yoga acts by reducing the activation and reactivity of the sympatho adrenal system and the hypothalamic–pituitary–adrenal axis and promoting feelings of well-being and fostering multiple positive downstream effects on neuroendocrine status, metabolic function, and related systemic inflammatory responses.[ ] Nutritional therapy has been recommended for people with prediabetes as a method to delay the progression to T2D.[ ] A previous study reported that lifestyle modification program decreased the number of people with prediabetes who acquired diabetes within 4 years to about 20%.[ ] Malhotra et al .[ ] reported that people with mild to moderate diabetes experienced significant reductions in fasting and postprandial blood glucose and insulin levels after 40 days of a yoga regimen combined with diet. Chimkode et al .[ ] reported that yoga is a cost-effective, noninvasive adjuvant therapy effective in reducing blood glucose levels, decreasing the dosage of oral hypoglycaemic drugs insulin, and delaying the progression of the disease process in patients with T2D.

However, there were very few randomized controlled trials (RCTs) evaluating and comparing the efficacy of the yoga-based lifestyle intervention (YBLI), which includes diet versus dietary intervention (DI) alone among people with prediabetes. Hence, the present study was conducted with two main objectives: (1) to evaluate the effect of YBLI on cardiometabolic risk factors namely blood glucose, glycated hemoglobin (HbA1C), lipid profile, heart rate variability (HRV), and carotid intima-media thickness (CIMT) among people with prediabetes and (2) to compare the efficacy of YBLI versus DI alone on cardiometabolic risk factors among people with prediabetes.

M ETHODS

### Study design

An open-label, two-arm, parallel-group, RCT design was implemented at the Department of Physiology and Medicine at RUHS College of Medical Sciences (RUHSCMS) and Associated Hospitals, Jaipur, Rajasthan, India. This trial was completed between September 2017 and November 2019. The trial protocol was approved by the RUHS Institutional Ethics Committee (ECR/762/Inst/RJ/2015/RR-22, EC/P/01/2016). The trial has been registered at the clinical trial registry India (CTRI/2017/06/008825). For this study, participants were divided into YBLI and DI groups following computer-generated randomization. Assessments were made at baseline and after 6 months of the interventions in DI and YBLI groups.

### Study advisement

The purpose and significance of the study were explained to the participants verbally and in the participant information sheet. They were given complete knowledge of the prediabetes and importance of nutrition and physical activity in alleviating it. We highlighted the need and benefits of a combined approach to yoga therapy to attract people with prediabetes.

### Screening procedure

Aged 30–50 years were voluntarily recruited at RUHS College of Medical Sciences and outpatient departments through hospital-based advertisements, face-to-face contact, word-of-mouth, and flyers. After that subjects contact the research staff. In this study, sources of data were collected from first-degree relatives of diabetics i.e., father, mother, and, sibling reason for the collection of data was that family history was an important source of genomic data for diabetes. A study reported the prevalence of diabetes was significantly higher among those who had a first-degree relative with the disease (14.3%) than it was among those who did not (3.2%).[ ] Information regarding people with diabetes was collected from hospital medical records. Participants who satisfied the inclusion criteria and signed the written informed consent were included in the study and their personal information was kept confidential.

### Recruitment of participants

The participants were recruited based on the following.

### Inclusion criteria

In this study, 30 to 50 years age group subjects were recruited irrespective to sex. Criteria behind age group selection were that in previous studies[ ] reported that the 30 to 50 years age group was more prone to develop prediabetes and after 50 years age group was not included due to autonomic dysfunctions in prediabetes Fasting blood glucose (FBG) levels of 110–125 mg/dL and HbA1c levels of 5.7%–6.4% Possession of an Android phone and WhatsApp application.

### Exclusion criteria

Subjects who have FBG <100 mg/dl and >126 mg/dl and HbA1C <5.7% and more than 6.4% Systolic blood pressure (SBP) >160 mmHg and diastolic blood pressure (DBP) more than 100 mmHg, Abnormal liver function test Alanine transaminase [ALT] and Aspartate transaminase [AST] >2.5-fold the upper standard limit Alcoholic individuals (weekly alcohol consumption >140g) Pregnant, lactating females (early pregnancy excluded by dates of last menstrual period if time interval >30–35 days for next menstrual period excluded) Comorbid conditions included cardiovascular, chronic liver, renal, pulmonary, neurological, and musculoskeletal disorders.

### Sample size calculation

The sample size calculation assumed from the available literature related to the effect of the yoga-based intervention on high-risk individuals with diabetes.[ ] The sample size is calculated at 250 at 95% confidence interval (CI), 5% type I (α) error, 80% power, and considering dropout rate of 20%, standard deviation (SD) = 9.49, Zα = 1.96 (Type I error of 5%); Zβ = 0.84 (80% power), and d = difference between mean values = 1.49. The sample size was calculated by (Zα + Zβ) 2 + (SD) 2 /d 2 = (1.96 + 0.84) 2 + (9.49) 2 /(1.49) 2 = 97.90 + 20% drop out rate = 97.90 + 25.85 = 123.75,125 subjects were recruited in each group.

### Randomization

A total of 2000 subjects were screened. Out of which 250 eligible individuals who met inclusion criteria were concealed and allocated by another person who was unaware of the study and randomly divided using computer-generated simple randomization into two groups the yoga-based lifestyle intervention group (including diet) ( n = 125) and DI alone. Blinding of the participants was not possible due to the nature of the intervention. However, the outcome assessors were blinded. A total of 250 subjects enrolled on a rolling basis [ ].

In this study, RCT followed the consolidated standards of reporting trials statement that was conceptualized to help ascertain the standardization and reproducibility of RCTs.[ ]

### Intervention

#### Dietary intervention

All subjects received the same diet plan from a qualified dietician as per dietary guidelines for Asian Indians.[ ] In Asian Indian dietary policies, the recommended nutrient composition for daily diet includes 50%–60% carbohydrates, 10%–15% protein, <30% total fat, <10% saturated fat, 10%–15% monounsaturated fat, 5%–8% polyunsaturated fat, <200–300 mg cholesterol, 25–40 g dietary fiber, and <5 g salt. Subjects were instructed to record their daily food intake in a diary. DI recommended participants decrease the intake of red meats, chicken, fish, eggs, refined grains, and sugars to prevent and manage prediabetes.[ ] Dietary assessment was done by food frequency questionnaire (FFQ)[ ] for calculation of total energy intake per day and follow-up was done monthly for 6 months. The FFQ was used to obtain the frequency and portion size of food and beverage consumption. A list of food items was prepared according to the Indian Council of Medical Research guidelines[ ] based on food items consumed in India. FFQ contains 92 food items. All 92 food items were categorized under nine groups. Nutrient scoring values were calculated from the nutrient database provided by the National Institute of nutrition guidelines, Hyderabad.[ ]

#### Yoga intervention

Participants in the YBLI group underwent a 24-week pretested, standardized comprehensive yoga-based lifestyle intervention. For the first 8 weeks, the intervention was held at the yoga laboratory in RUHSCMS, Jaipur. For the next 16 weeks, study participants were advised to continue the same yoga intervention themselves in their homes. To facilitate and guide home practices video clips were shared on the WhatsApp application. Yoga asanas were supervised by a yoga instructor and investigators through weekly online zoom meetings. A total of 25 participants were in each meeting. For follow-up, participants have to come every month to the yoga laboratory for the next 16 weeks. The structure and validation of the yoga-based lifestyle intervention program have been published previously.[ ] The 45-min yoga sessions were conducted from 7:00 to 7.45 am every morning 6 days per week over a period of 6 months under the direct supervision of a certified trained yoga instructor. The yoga instructor had obtained a 2-year postgraduate (MA) in yoga therapy. All the yoga asanas and postures were explained and demonstrated by the yoga instructor. Yoga protocol constitutes prayer, omkar recitation, different asanas (SuryaNamaskar, Sukhasana, Bhujangasana, Pashimottanasana, Padmasana, Tadasana, Trikonasana, Sarvangasana, Ardhmatsyendrasana, Pawanmuktasana, Vajrasana, Dhanurasana), breathing practices (pranayama), and Shavasana. End of each yoga session was with 5 min of relaxation with Shavasana followed by interactive lectures and one-to-one interactions. The total duration of yoga sessions was 45 min six days a week over a period of 6 months. Subjects in both the YBLI and DI groups were administered the same DI as the standard of care for 24 weeks.[ ]

To ensure compliance first, we ensured that all the subjects had an Android phone and have WhatsApp application; after that, we prepared groups and shared video clips of the yoga protocol on it. The YBLI group was provided an instruction manual, images of yoga sequences, video clips, and diet plans, and DI group was provided only diet plans. Short messages related to the dietary and yoga intervention were also shared with all the participants. Daily messages were delivered both in Hindi and English language. In the message, we asked did you perform yoga asanas today? Further to record and reinforce the recommended intervention at home, the participant's YBLI group was provided with a yoga and diet diary while the DI group was provided only a diet diary. The subjects were instructed to record their daily food intake and yoga details in the diary. The total duration of the diet counseling session was 30 min, 3 days per week over a period of the first 8 weeks and the next 16 weeks’ follow-up on online Zoom meetings. Sessions were conducted by a dietician at RUHS Hospital. They were given complete knowledge of the importance of nutrition in alleviating prediabetes.

#### Adherence/fidelity to intervention

Adherence to yoga sessions was assessed by research staff on the participant's daily attendance at the yoga laboratory. An attendance register was maintained in which their daily attendance was recorded by the yoga instructor. Adherence was assessed as the total number of sessions attended by the participant out of the total number of sessions conducted in the yoga laboratory in a month. For home practices, adherence was assessed through attendance of online sessions. Adherence was also ensured by regular replies to daily messages, weekly telephonic conversations with subjects and family members, face-to-face discussions, and reviewing the diet and yoga diaries when they come for follow-up on a monthly basis. Adherence to diet was calculated by reviewing diet diaries by dieticians and research staff. Participants who may not have completed their daily logs in their diary, discontinued yoga sessions, or not participated in telephonic conversations, and zoom meetings were excluded from the analysis. They were not invited for a follow-up assessment and their data were excluded from the analysis and considered dropouts. There was no modification in the intervention during the study.

### Safety

Study participants were asked if they had ever experienced an acute injury or other acute complaints during yoga practice. If participants reported that they had experienced an adverse event they were also asked to report the number of events. Participants were also asked to indicate whether they recovered, how long they had practiced yoga when the adverse effect occurred, and whether the adverse effect occurred during supervision by a yoga instructor or during self-directed yoga practices at home. Most of the participants reported acute adverse effects associated with the musculoskeletal system such as strains and sprain.

### Outcome measures

Anthropometric parameters such as weight, height, body mass index (BMI), and waist–hip ratio (WHR) were measured. The subject's weight was measured on a calibrated digital machine (sec 101, beat XP) with the minimum of clothing to the nearest 0.1 kg. The height of the subject was measured to the nearest 0.1 cm using a standard stadiometer. BMI was calculated using Quetelet's index-weight (kg)/height (m) 2 . Waist circumference (cm) was measured midway between the lowest rib and superior border of the iliac crest using an elastic measuring tape on the bare skin at the end of expiration and recorded to the nearest 0.1 cm. Hip circumference (in inches) was measured with the measuring tape to the nearest 0.1 cm at the widest point around the greater trochanter. SBP and DBP, pulse were estimated as the mean of the two measures in a sitting position after a 10-min resting period with a validated automatic blood pressure monitor (Omron HEM 7120). Stress was measured by Cohen's perceived stress scale. The Cohen Perceived Stress Scale (PSS) was a widely used psychological instrument for measuring the degree of stress. It was a measure of the degree to which situations in life are appraised as stressful. The scale includes psychometric properties of the 10-item, i.e., general nature of thought and feeling in the past month and current levels of experienced stress.[ ]

### Biochemical investigations

All individuals got a screening laboratory assessment. The biochemical parameters of FBG, HbA1C, and serum lipid profile were assessed at baseline and after 6 months in YBLI and DI groups. A fasting blood sample was taken. The FBG and HbA1C were assessed by the glucose oxidase-peroxidase endpoint method,[ ] and immunoturbidimetric method, respectively.[ ] Serum lipid profiles included total cholesterol (TC), triglyceride (TG), and high-density lipoprotein (HDL) were assessed by CHOD-PAP,[ ] GPO-PAP,[ ] and phosphotungstic acid endpoint method,[ ] respectively. Low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL) were calculated from the Friedewald formula.[ ] The liver function tests included alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase. Liver function tests were performed on a fully automated analyzer based on the principle of photometry.[ ]

### Cardiovascular investigations

HRV was recorded with the help of a digital physiograph (Model: AD Instruments 3818) using a standard bipolar limb lead configuration. Frequency domain analysis of HRV data was carried out. HRV analysis software (version 1.1, Biomedical Signal Analysis team, University of Kuopio, Finland)[ ] assessed by frequency components using fast Fourier rapid transformation. The results of the frequency spectrum analysis were given as spectral strength including very low frequency (VLF; 0.003 Hz–0.04 Hz), low frequency (LF; 0.04 Hz–0.15 Hz), and high frequency (HF; 0.15 Hz–0.4 Hz).[ ]

CIMT was measured in the posterior wall of carotid arteries with a B-mode Acuson Sequoia ultrasonography device.[ ] The scanning duration was 30 min. All the sessions were assessed by a radiologist. However, the outcome assessors were blinded.

### Statistical analysis

The statistical analysis was done in five steps using IBM Corp. Released 2019. IBM SPSS Statistics for Windows, Version 26.0. (Armonk, NY: IBM Corp). In the first step baseline comparison was done between YBLI ( n = 125) and DI ( n = 125) alone groups. The second step was a paired-sample t -test of the pre-post data of YBLI and DI groups. In the third step, pre–post differences of various parameters were compared between YBLI and DI groups. The fourth step compared an independent t -test between the mean post-intervention comparison done between YBLI and DI alone groups. In the fifth step an independent sample t -test for the comparison of males versus females in DI and YBLI groups. Before the t -test, the test for homogeneity was carried out by Levene's test for equality of variance for the variables of both groups to be homogeneous ( P > 0.05), and the Shapiro–Wiki test was done for normal distribution of variables ( P > 0.05). The level of significance was taken at 5%. Inference of significance is drawn on the value of P .

R ESULTS

A total of 250 participants were enrolled in the study out of the 2000 individuals screened for the study. They consisted of 102 males and 138 females. The age ranged between 30 and 50 years. Demographic details are given in . The mean age of the participants in the YBLI and DI groups was 42.5 ± 10.45 years and 42.7 ± 9.51, respectively, and the age difference between the two groups was not statistically significant.

In the second step of the analysis, a paired sample t -test of the pre–post data from both groups was done to compare the mean differences between baseline and postintervention scores. The YBLI group showed a significant difference in the mean values of BMI, WHR, SBP, DBP, PR, FBG, HbA1C, lipid profile; TG, TC, LDL, HRV, CIMT, and FFQ (all P < 0.01) that indicated decreased glycemic parameters, lipid profile, CIMT, and the autonomic nervous system shifted toward parasympathetic dominance and statistical nonsignificant difference observed in HDL, and VLDL [ ].

The control group also showed statistical pre–post differences in the mean values of BMI, WHR, SBP, DBP, pulse rate, FBG, HbA1C, and lipid profile; TG, TC, LDL, and HRV ( P < 0.05). However, the pre–post mean values of PSS score, HDL, VLDL, and CIMT did not show any significant reduction in the control group ( P > 0.05) [ ].

In the third step of the analysis, the magnitude of reduction (i.e., pre–post difference) of values of BMI, WHR, SBP, DBP, PR, PSS score FBG, HbA1C, lipid profile; TG, TC, LDL, HRV, and CIMT was compared between YBLI and DI groups. For this analysis, the pre-minus-post differences were first calculated for all values of both the groups then an independent t -test was applied to find the statistical difference between the two as shown in . BMI, WHR, SBP, DBP, PR, FBG, HbA1C, lipid profile; TG, TC, LDL, HRV, CIMT, and FFQ showed a significantly higher mean reduction in the YBLI group compared to the DI group ( P < 0.05) and nonsignificant decline in HDL ( P > 0.05) [ ].

In the fourth step, an independent sample t -test revealed a statistically significant difference between the postintervention mean scores of the YBLI and DI groups for BMI, WHR, SBP, DBP, PR, PSS score, FBG, HbA1C, lipid profile; TG, TC, LDL, VLDL HRV, and CIMT showed a significant reduction in the YBLI compared to the DI group ( P < 0.01) and a nonsignificant reduction in TC, HDL, and FFQ ( P > 0.05) [ ].

Pre–post mean differences with 95% CI of cardiometabolic parameters namely BMI, WHR, SBP, DBP, PSS, FBG, HbA1C, lipid profile TG, TC, LDL, VLDL, HDL, HRV, and CIMT in the YBLI and the DI group. Results showed YBLI group had greater mean differences when compared to the DI group [ ].

In the fifth step, an independent sample t -test was used for the comparison of males versus females in DI and YBLI groups, but the results were nonsignificant.

In this study, there were nine dropouts: five dropped out of the YBLI group and four dropped out in the DI-alone groups. In this study follow up of subjects done by intent to treat analysis in this participant are analyzed according to their randomized assignment in original exposure group.

The dropout rate was <10% among the YBLI and DI groups. Adherence to yoga-based lifestyle intervention was 77% and home practices occur 75% over a period of 6 months. Average yoga attendance was 76%; hence, participants who had a minimum attendance of 75% were considered completers.[ ] Adherence to the DI was 75%.

D ISCUSSION

To the best of our knowledge, this is the first RCT to evaluate the efficacy of a 24-week YBLI versus DI among people with prediabetes in Rajasthan.

Results of this study showed that yoga-based lifestyle intervention, including diet, resulted in a significantly greater decrease in weight, WHR, BMI, blood pressure, stress score, glycaemic parameters, lipid profile, HRV, CIMT, and FFQ from baseline assessment compared to the DI group who received DI alone. The baseline comparison between the two groups for metabolic parameters showed no significant group differences, as shown in .

The baseline similarity between the groups suggests that the randomization was reasonable and mean scores were related to both YBLI and DI groups rather than confounding factors.[ ] The essence of a randomized trial is to compare the outcomes of YBLI and DI groups of individuals that start off the same.[ ] However, analysis in and 3 shows a greater reduction of weight, BMI, and WHR, perceived stress score (PSS) in the YBLI group compared to DI alone, consistent with previous studies.[ ]

This may imply that the YBLI helped to significantly decrease stress scores, CIMT, and increased HDL as compared to the DI group [ ]. The benefit can be attributed to a greater weight loss in the YBLI group probably due to an increase in physical activity, the flexibility of limbs and stretching of different body parts, deep breathing following yoga asana and pranayama along with dietary changes leads to a reduction of subcutaneous adipose tissue and prevention of cardiometabolic risk factors related to obesity.[ ]

Further analysis of pre–post blood glucose and HbA1C mean values revealed a greater significant decrease in the YBLI group compared to the DI group [ , 3 and ]. similar to the previous studies.[ ] The decrease in blood glucose in the YBLI group is due to abdominal stretching during yoga exercises resulting in the regeneration of pancreatic cells and helps to improve the sensitivity of β-cells to glucose, thereby improving insulin secretion and increasing the blood supply to the muscle and muscle relaxation, thereby improving glucose uptake, and hormonal homeostasis, and also improving glycaemic control in people with prediabetes.[ ] Asanas involve stretching/twisting movements and relaxation. Seated postures such as Ardha Matsyendrasan, Sukhasana , and Dhanurasana improve pancreatic function . [ ] In the present study, depicts a decreased in TG, TC, LDL, and increased HDL observed in the YBLI is in line with the earlier studies done by Tuso et al. ,[ ] Ross et al .,[ ] and Sahay et al .[ ] The reason behind this is that an increase in physical movement in yoga decreases cholesterol, TGs, and LDL and raises HDL levels, and increases the uptake of TG by fatty tissues.[ ] This effect could also be attributed to DI due to the low fat, high complex carbohydrate nature of the diet or the low dietary cholesterol intake.[ ]

As shown in and 3, the LF/HF ratio of the frequency domain of HRV showed a higher mean reduction in the YBLI group as compared to DI group, consistent with previous studies.[ ] Further studies reported that yoga practitioners showed beneficial activity of vagal afferents and sympathovagal balance compared to non-yoga practitioners. Regular yoga practices help in decreasing cardiovascular risk factors and improve homeostasis at the neuroendocrinal level, increasing exercise self-efficacy in people with prediabetes.[ ]

The postintervention mean reduction in CIMT in the YBLI group compared to the DI group as shown in is similar to previous studies.[ ] The probable mechanism of the decrease in CIMT after yoga-based lifestyle intervention is due to an improvement in cardiac autonomic reactivity associated with a decrease in CIMT. Our results were in line with the hypothesis that carotid atherosclerotic lesions were associated with autonomic function impairment.[ ] Regular yoga practices along with diet represent a valuable strategy to counteract artery structural changes and cardiac autonomic dysfunctions.[ ] The Previous finding suggests that about a 40% reduction in cardiovascular mortality is expected in coronary artery disease patients who practice a healthy lifestyle.[ ] The key strength of our RCT was the use of randomization, including diet as a standard of care in the YBLI and DI groups and gender-specific assessment of cardiometabolic parameters. The results of this study can help provide information that will help guide primary healthcare workers, policymakers, and researchers in their development, selection, and improvement of their therapeutic interventions.

### Limitation

The finding of this study needs to be explored in a larger sample size involving people with prediabetes. Further research is also necessary to determine the long-term effect of yoga practices. In this study, we have reported only the short-term (24 weeks) effects of yoga without exploring the long-term effects (years). In essence, it may be that short-term beneficial effects could get amplified with long-term practice. In addition, there was an unequal distribution of gender in the sample, with more females than males. RCTs were associated with limited external validity and consequently low generalizability due to the stringent inclusion, exclusion, and intervention criteria, small sample size, and short duration.

C ONCLUSION

The overall finding of this study showed that 24-week yoga-based lifestyle intervention programs were an effective strategy for reducing weight, WHR, blood pressure, stress, glycaemic parameters, lipid profile, HRV, and CIMT compared to DI alone. Therefore, lifestyle intervention applies to managing and preventing prediabetes, diabetes, and its complications through a wide range of physiological and metabolic processes.

### Ethics approval and consent to participate

This study was approved by the RUHS Institutional Ethics Committee (Registration no. ECR/762/Inst/RJ/01). The participants received explanations of the purpose and contents of the study, the voluntary nature of their participation, and the benefits of this yoga practice in the participant information sheet. The written informed consent form was then obtained from each participant's parents.

### Consent for publication

I understand my rights and my responsibilities as a participant in this study. I permit the investigator to utilize my information and the results obtained from this study for presentation and publication. (participant language).

### Data availability statement

The data that support the findings of this study will be made available from the corresponding author, upon request.

### Financial support and sponsorship

Nil.

### Conflicts of interest

There are no conflicts of interest.