|Year : 2021 | Volume
| Issue : 3 | Page : 131-138
Reduction of cardiometabolic risk factors with lifestyle intervention: Randomized controlled trial for efficacy among corporate workers
Abiodun Bamidele Adelowo
Department of Human Kinetics and Health Education, University of Lagos, Lagos, Nigeria
|Date of Submission||30-Apr-2021|
|Date of Decision||08-Jul-2021|
|Date of Acceptance||10-Jul-2021|
|Date of Web Publication||22-Sep-2021|
Abiodun Bamidele Adelowo
Department of Human Kinetics and Health Education, University of Lagos, Lagos
Source of Support: None, Conflict of Interest: None
Background: Cardiovascular diseases and Type 2 diabetes mellitus are two leading noncommunicable diseases globally. Mitigating their overlapping cardiometabolic risk factors have been identified as vital to the global effort to prevent and control these chronic diseases. Objective: The purpose of the study was to examine the efficacy of lifestyle education intervention on cardiometabolic risk factors. Subjects and Methods: A prospective, placebo-controlled, parallel-group, randomized trial was used to conduct a 12-week lifestyle educational intervention on 184 corporate workers. The collected data were analyzed with analysis of covariance at 0.05 alpha level. Results: The treatment significantly improved the mean difference (all P < 0.05) of the intervention groups' fruits and vegetable consumption (0.64, 95% confidence interval [CI]: 1.03–1.81), physical activity (0.38, 95% CI: 1.22–1.80), and attitude toward healthy living (22.3, 95% CI: 35.56–59.37). It also significantly reduced the mean difference of the participants' salt intake (0.39, 95% CI: 1.44–1.99), daily tobacco use (0.12, 95% CI: 1.70–1.96), alcohol consumption (0.31, 95% CI: 0.37–0.99), resting heart rate (−4.81 bpm, 95% CI: 77.89–84.65), systolic blood pressure (−5.52 mmHg, 95% CI: 117.9–127.61), diastolic blood pressure (−4.41 mmHg, 95% CI: 75.10–81.47), body mass index (−1.78, 95% CI: 24.58–27.65), waist circumference (−0.90 cm, 95% CI: 87.70–91.53), fasting blood glucose (−0.36 mmol/l, 95% CI: 4.84–5.48), total blood cholesterol (0.41 mmol/l, 95% CI: 4.41–5.19), and type 2 diabetes risk scores (−1.76, 95% CI: 5.25–8.86). Conclusion: Lifestyle education is an effective intervention program in reducing the prevalence of cardio-metabolic risk factors among corporate workers.
Keywords: Cardio-metabolic risk factors, cardiovascular diseases, corporate workers, lifestyle intervention, noncommunicable diseases, type 2 diabetes mellitus
|How to cite this article:|
Adelowo AB. Reduction of cardiometabolic risk factors with lifestyle intervention: Randomized controlled trial for efficacy among corporate workers. J Diabetes Endocr Pract 2021;4:131-8
|How to cite this URL:|
Adelowo AB. Reduction of cardiometabolic risk factors with lifestyle intervention: Randomized controlled trial for efficacy among corporate workers. J Diabetes Endocr Pract [serial online] 2021 [cited 2021 Dec 7];4:131-8. Available from: https://www.jdeponline.com/text.asp?2021/4/3/131/326370
| Introduction|| |
The cardiovascular diseases (CVDs) are the leading noncommunicable diseases (NCDs) globally, contributing substantially to the global burden of diseases and the escalating costs of health care. According to the World Health Organization (WHO), as of the year 2016, the estimated global deaths attributable to CVDs was 17.9 million (31% of total death) with 37% of premature deaths below the age of 70 years. CVDs, largely heart diseases and stroke, also accounted for 50%–80% of NCD-related deaths in the low-and middle-income countries, and 11% of such deaths were recorded in Nigeria., The World Heart Federation warned that by the year 2030, almost 23.6 million people worldwide will be expected to die from CVDs, thereby making the disease condition the biggest threat to the well-being and socioeconomic development of the 21st century.
Diabetes mellitus, particularly type 2 (T2DM), is another NCD of an epidemic proportion in most regions of the world. The International Diabetes Federation categorizes it as one of the largest global health emergencies of the 21st century and the third leading cause of premature death worldwide, affecting about 8.8% of the global adult population., In Nigeria, the prevalence of T2DM is around 2.8% (7.2% in urban and 0.65% in rural areas), with a disease-proportional death rate of about 1%., Unless definite mitigating measures are taken, these statistics will likely continue to increase.
An interesting concern is the similar and overlapping risk factors for both CVDs and T2DM. Obesity (particularly central), insulin resistance, high blood glucose, high blood cholesterol, and high blood pressure are all established intermediate-risk factors that the two disease conditions share in common which can then be exaggerated to full disease states in the presence of aging, physical inactivity, unhealthy diet, and tobacco use.,,,, These combined risk factors for CVDs and T2DM are commonly called cardiometabolic risk factors, and considering the interplay in the pathophysiology of the two chronic diseases, CVDs preventive strategy is inadequate and incomplete unless and until the risk for T2DM is adequately assessed and controlled.,
The burden of CVDs and T2DM is increasing globally and the knowledge and understanding of their prevention and control are also increasing., It has been estimated that about 80% of CVDs and T2DM could be prevented, and countries can reverse the advances of these diseases and achieve immediate gains if appropriate preventive interventions are implemented. Part of the cornerstone interventional measures that have been proposed by the United Nations and the WHO is to adopt a comprehensive preventive approach that targets the cardio-metabolic risk factors., Such strategy especially interventions that focus on unhealthy lifestyle choices can have a significant positive impact on decreasing the incidence of initial and recurrent cardiovascular and metabolic events.
It has been estimated that a reduction of chronic disease death rates by just 2% a year through effective lifestyle intervention would avert 35 million deaths over 10 years and at least half of T2DM cases could be prevented or delayed. Consequently, it has been recommended that people at high risk for T2DM or with multiple cardiometabolic risk factors should receive appropriate education on lifestyle modification, and if needed pharmacological therapy, to reduce or delay their risk of developing T2DM and CVDs., Such interventional measure if diligently executed can result in more than a fivefold return in investment when compared with most other clinical preventive measures (like pharmacotherapy), even when imperfect. The trial has therefore examined the effects of lifestyle educational intervention on the risk factors associated with developing CVDs and T2DM among corporate workforce in a developing country.
| Subjects and Methods|| |
The specific objectives of the study were to determine the effect of lifestyle education intervention on the following primary and secondary outcomes among the participants: (1) lifestyle practices (fruits and vegetable consumption, added salt intake, physical activity, tobacco use, and alcohol consumption), (2) biophysical profiles (resting heart rate, blood pressure, body mass index [BMI], and waist circumference), (3) biochemical profiles (fasting blood glucose [FBG] and total blood cholesterol [TBC]), (4) attitude toward healthy living, (5) total CVDs risk scores, and (6) type 2 diabetes risk scores.
The study, which is a Ph.D. thesis work, was a multicenter, prospective, placebo-controlled, parallel-group, randomized study that was conducted in Nigeria (2 sites). Using a predesigned protocol, 184 apparently healthy corporate workers were randomly assigned to two parallel groups in 1:1 ratio, to receive either lifestyle education intervention, or education on hepatitis as control for 12 weeks.
Inclusion criteria were corporate (white-collar) workers aged 40 years and above, who had mobile phone (with a WhatsApp platform). The selected age range is in accordance with the eligibility criteria for using one of the research instruments (the World Health Organization/International Society of Hypertension Cardiovascular Risk Prediction Chart). An internal advertisement was made in the participant's place of work, and the interested people were self-selected, out of which the study population where randomly selected. The verbal and written informed consent of all the participants were obtained before enrolling them into the study.
Exclusion criteria were participants with self-reported medical history of any of ischemic heart disease, hypertensive heart diseases, stroke, hypertension, diabetes mellitus, and pregnancy or are using antihypertensive(s), antihyperglycemic medication(s), or lipid-lowering drugs and also excluded are any participant who on screening were noticed to have the following health condition: blood pressure level of ≥140/90 mmHg, FBG level of ≥7.0 mmol/l, and TBC level of ≥8 mmol/l. It will be ethically and professionally inappropriate to commence only lifestyle intervention for these group of people for 12 weeks, without appropriate pharmacological intervention.
The study took place in two corporate organizations with similar working environments. The intervention was at the State House Complex and the control was at the Federal Inland Revenue Services Office. Both centers are located in the Federal Capital Territory (Abuja) of Nigeria. The recruitment and follow-up period of the study was between October, 2018 and January, 2019.
The intervention group received a twice-a-week health education lecture on cardiometabolic risk factors, lifestyle modification, and behavioral change for initial 4 weeks. The lecture was guided by a self-developed health educational manual (a copy was given to all the intervention group participants). The manual (titled, “Seven Steps to a Healthy Life”) was validated by different related health and medical experts and was designed mainly in accordance with the guidelines and recommendations of two standardized documents: the WHO's “Prevention of CVDs: Guidelines for Assessment and Management of Cardiovascular Risk,” and the WHO's “Training Manual for Health Workers on Healthy Lifestyle: An Approach for the Prevention and Control of NCDs., The modules covered in the manual include: Module 1 (Exposing the modern killers), Module 2 (Step 1 – Eat Right for Life), Module 3 (Step 2 – Move your Body), Module 4 (Step 3 – Watch your Weight), Module 5 (Step 4 – Say No to Tobacco), Module 6 (Step 5 – Limit your Alcohol), Module 7 (Step 6 – Take your Rest Serious), and Module 8 (Step 7 – Get Checked and Know your Numbers). Subsequently, structured follow-up discussions and counseling were done for another 8 weeks, through WhatsApp platform, mobile phone calls, and SMS. Concurrently, the control group participants received series of lectures on hepatitis (awareness, types, transmission, diagnosis, complications, and management).
The primary outcomes for the study are the mean changes in the investigated cardiometabolic risk factors that can increase the risk of developing CVDs and T2DM among the participants. These primary outcomes of the study are categorized into 3: (A) the mean changes in the lifestyle practices of (1) frequency of consumption of fruits and vegetables per week, (2) adding salt to food after cooking or while eating, (3) current intake of tobacco products, (4) passive smoking, (5) alcohol abuse, and (6) moderate-intense physical activity per week; (B) The mean changes in the biophysical measurements of (1) BMI, (2) waist circumference, (3) blood pressure, and (4) resting heart rate; and (C) the mean changes in the biochemical measurements of (1) FBG and, (2) TBC. The secondary outcomes are the mean changes in the participants': (1) attitude toward healthy living, (2) total CVD risk score, and (3) type 2 diabetes risk score.
The outcomes (pretest and posttest) from all the participants (intervention and control) were assessed with a mercury sphygmomanometer, stadiometer, and four other standardized and validated instruments: Public Attitudes to Health Promotion and Disease Prevention questionnaire (r = 0.82), WHO STEPwise Approach to Chronic Disease Risk Factor Surveillance questionnaire (r = 0.74), WHO/ISH CVDs Risk Prediction Charts (r = 0.64), and Finnish Diabetes Risk Score questionnaire (r = 0.77). The instruments were administered by 5 certified health-care professionals.
Sample size determination
The sample size for the study was calculated using the formula by Cochran (n = z2pq/d2), where: “n” is the desired sample size (when the study population is >10, 000), “z” is the standard normal deviate, usually set at 1.96 (which corresponds to 95% confidence interval [CI]), “P” is the prevalence of 12.5% of high blood pressure from a previous local study, “q” is 1 – p, and “d” is degree of accuracy desired (which is set at 0.05). Using the formula, the actual sample size was calculated as 168, but this was increased by 10% attrition rate to 184.
Application of the exclusion criteria reduced the participants from 442 to 291. To avoid selection bias, simple random technique was manually used to select the final study population [Figure 1]. Here, the numbers corresponding to the names of all the participants on a sample frame were put in a nontransparent bag, and 184 participants (92 for the intervention group and 92 for the control group) were randomly picked at ratio 1:1 without replacement. Although the participants and the principal investigator were aware of the treatment, the data collectors and data analysts were kept blinded to the allocations.
The posttest data were collected, coded, and analyzed using the Statistical Package of the Social Sciences (SPSS) (IBM Corp. Released 2011. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp). The aim was to assess whether there were significant changes in the pretest and posttest data. Descriptive statistics of frequency counts, mean, and percentages were done to describe the basic demographic features and the outcomes, while the inferential statistics of analysis of covariance and Post-Hoc analysis was used to test the hypothesis at a 0.05 level of significance.
| Results|| |
Characteristics of the study population
During the study period, 4 participants (2 traveled, 1 when on annual leave, and 1 lost interest) in the intervention group and 2 participants (the 2 were transferred to another branch of the organization) in the control group withdrew from the study.
In the intervention group, 51 (57.9%) of the participants were of the male gender, while 37 (42.1%) were females. Furthermore, most (57.9%) were between the active working-age group of 40–49 years, and only 5.7% were in the retirement age of ≥60 years. Similarly in the control group, 49 (54.4%) and 41 (45.6%) of the participants were of the male and female gender, respectively, while the percentage of people age 40–49 years and ≥60 years were 68.8% and 2.2%, respectively [Table 1].
The posttest mean scores of all the six measured lifestyle practices primary outcomes were noticed to have improved in the intervention group compared to the control group [Table 2]. Specifically, the mean changes in the healthy lifestyle practices among the intervention group include the following: consumption of fruits and vegetables 5 or more days a week (0.64, 95% CI: 1.03–1.81), avoidance of added salt to food after cooking (0.39, 95% CI: 1.44–1.99), avoidance of daily tobacco use (0.12, 95% CI: 1.70–1.96), avoidance of passive smoking (0.17, 95% CI: 1.05–1.60), moderate alcohol consumption (0.31, 95% CI: 0.37–0.99), and participation in moderate – intense physical activity 5 or more days a week (0.38, 95% CI: 1.22–1.80). All these mean changes were statistically significant at 0.05 alpha level.
|Table 2: Effect of lifestyle intervention on healthy lifestyle practices|
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The individual mean scores of all the six measured biophysical primary outcomes reduced in the posttest intervention group compared to the control group [Table 3]. Specifically, the mean difference in the biophysical measurements of the intervention group includes the following: BMI (−1.78, 95% CI: 24.58–27.65), waist circumference (−0.90 cm, 95% CI: 87.70–91.53), systolic blood pressure (SBP) (−5.52 mmHg, 95% CI: 117.9–127.61), diastolic blood pressure (DBP) (−4.41 mmHg, 95% CI: 75.10–81.47), and resting heart rate (−4.81 bpm, 95% CI: 77.89–84.65). All these mean changes were statistically significant at 0.05 alpha level.
|Table 3: Effect of lifestyle intervention on the biophysical and biochemical measurements|
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The posttest mean scores of the two measured biochemical primary outcomes also reduced in the intervention group compared to the control group [Table 3]. Specifically, the posttest mean score of FBG reduced by −0.36 mmol/l (95% CI: 4.84–5.48) while that's of the TBC reduced by −0.41 mmol/l (95% CI: 4.41–5.19). These mean changes were statistically significant at 0.05 alpha level. Hence, the study concluded that the 12-week lifestyle educational intervention significantly improves the measured primary outcomes of lifestyle practices, biophysical, and biochemical profiles of the participants.
In regard to the secondary outcomes of the study, the posttest mean score of the attitude of the participants toward healthy living in the intervention group was at 59.16, with a significant mean difference of 22.27 (95% CI: 35.56–59.37), compared to the control group (mean = 37.53, standard deviation [SD] = 5.42) [Table 4]. The mean difference in the intervention group was statistically significant at 0.05 alpha level. The pretest mean type 2 diabetes risk scores of the intervention and control groups were 7.82 and 6.43, respectively. After the treatment, the intervention group had a lower mean score of 6.06 and a negative mean difference of −1.76 (95% CI: 5.25–8.86), while the mean T2DM risk score of the control group increased to 6.71 [Table 4]. This mean difference in the intervention group was statistically significant at 0.05 alpha level. Furthermore, the pretest mean total cardiovascular (CVD) risk scores of participants in the intervention and control groups were 5.45 and 5.22, respectively [Table 4]. After the treatment, the intervention group had a lower mean total CVD risk score of 5.11 and a negative mean difference of −0.34 (95% CI: 4.89–5.90), compared to the control group (mean = 5.22 SD = 1.48). However, this posttest mean difference was not statistically significant. This result means that the 12-week lifestyle intervention program was effective in improving the attitude of the participants toward healthy living and also significantly reduces their diabetic risk, but not their total CVD risk.
|Table 4: Effect of lifestyle intervention on attitude toward healthy living, total cardiovascular, and type 2 diabetes risk scores|
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No significant harm was recorded on the participants throughout the study duration. However, one of the intervention group participants strained her ankle joint during one of her walking sessions.
| Discussion|| |
The study demonstrated that most of the participants are within the active working age group of 40–49 years. This finding is similar to the result of a study that was conducted among the Indian workforce, in which the mean age group for the intervention and control groups were 40.8 and 38.6 years, respectively; while a systematic review also revealed that most of the people that constitute the corporate workforce in the study are within the active age group and below the retirement age of 60 years. Age is an independent risk factor and positively correlates with most CVDs and T2DM.,, Since the majority of the corporate workforce are within the active age of 40–49 years, workplace health promotion programs provide a golden opportunity to reduce the cardiometabolic risk factors as much as possible in this cluster of people.
The study revealed that the 12-week lifestyle educational intervention significantly improved the primary outcomes (all P < 0.05) among the participants. It increased the frequency of consumption of fruits and vegetables per week and increased moderate-intense physical activity per week. It also significantly reduced certain unhealthy lifestyle practices, like adding salt to food after cooking, intake of daily tobacco products, passive smoking, and alcohol abuse. The intervention also significantly reduced the measured biophysical and biochemical primary outcomes among the participants: BMI, waist circumference, systolic and DBPs, resting heart rate, FBG, and TBC.
The results of the study are similar to the findings of most previous studies that investigated the effects of lifestyle intervention on selected cardiometabolic risk factors. An intervention study conducted on the American population revealed that after lifestyle education intervention, there was a significant improvement in the participants' nutritional choices and physical activities. Specifically, there was a positive mean change of 5.41 in the participants that consume ≥5 servings of fruit and vegetable per day. The mean biophysical changes in the intervention group improved by reduction in body weight (−3.4 kg), SBP (−7.20 mmHg), DBP (−5.04 mmHg), resting heart rate (−2.83 bpm), FBG (−4.11 mg/dl), and TBC (−14.43 mg/dl). Another intervention study still on the American population revealed that after lifestyle educational intervention, there was a significant improvement in the dietary choices, physical activity, and other healthy lifestyle practices of the participants. Specifically, for the intake of fruits and vegetables, the mean intake at baseline was 8.2; this improved to 14.2 after 6 weeks, and further to 16.8 after 18 months' postintervention.
A clinical trial that was conducted by McGuire et al. on Americans with pre-and stage 1 hypertension revealed that after 6 months' post lifestyle education intervention, the mean body weight, SBP, and DBP of the participants reduced by −4.9 kg, −10.5 mmHg, and −5.5 mmHg, respectively. Another lifestyle education intervention study that was titled the Coronary Health Improvement Project Study revealed that after the intervention, the values of the biophysical measurements of the participants reduced by – BMI (−3.2%), SBP (−4.9%), DBP (−5.3%), TBC (−11.0%), and FBG (−6.1%). Furthermore, a combined systematic review and meta-analysis to evaluate the effect of lifestyle education program on patients with metabolic syndrome revealed that after the intervention, the mean scores of the measured biophysical variables significantly reduced as follows: SBP by −6.4 mmHg, DBP by −3.3 mmHg, and waist circumference by −2.7 cm. Moreover, a lifestyle education-based study that was conducted by Prabhakaran et al. on the Indian workforce revealed that after the intervention, the blood glucose in the intervention group reduced by −9.4%.
The 12-week lifestyle educational intervention also significantly improved two of the three secondary outcomes (all P < 0.05). It significantly improved the attitude of the participants toward healthy living and also reduced their type 2 diabetes risk, but not the total CVD risk. Although the total CVD risk scores of the intervention group reduced after the treatment, the changes were not statistically significant. This result might not be unrelated to the stringent exclusion criteria which the researcher adopted for the study. Due to the exclusion criteria, most of the study participants already had preintervention low total CVD risk scores, and hence, the treatment had an insignificant effect on the scores. Other lifestyle education intervention studies that used less stringent exclusion criteria reported significant changes in the total CVD risk scores of their study population.
Prabhakaran et al. reported a significant postintervention total CVD risk score reduction of 7.3 in the intervention group, while the total CVD risk score of the control group increased by 9.3. Another study conducted by Van De Rest et al. also noticed a significant improvement in the total CVD risk scores after lifestyle education. The result of this study is noticed to be lower than the World Health Organization's projection for Nigeria, which projected a mean total CVD risk score of 6.7% for men and 8.6% for women in the country. The result of T2DM risk of the participants in this study is slightly higher than the result of a local study in Nigeria by Alebiosu et al., which indicated that the mean T2DM risk score in Nigeria was around 5.60; but lower than the result of another local study, which noticed a mean T2DM risk score of 13.32 (12.90 in males and 12.86 in females) among the participants.
The results of the present study support the available evidence that poor lifestyle choices such as unhealthy diet, physical inactivity, harmful use of alcohol, and tobacco use; together with biological risk factors, like obesity, high blood pressure, high blood glucose, and high blood cholesterol, are modifiable cardiometabolic risk factors for chronic NCDs. The WHO informed that reduction of these risk factors through appropriate lifestyle changes and access to easy-to-interpret health information could significantly prevent, or at least reduce the rising burden of most CVDs and T2DM. This study demonstrated that a well-designed workplace lifestyle education intervention program can significantly improve healthy lifestyle choices and reduce the rates the biological risk factors among corporate workers.
The position was supported by the Commonwealth Business Council which opined that about half of deaths caused by NCDs, like CVDs and T2DM, could be prevented through increased health education and literacy, health awareness, and simple lifestyle and behavioral changes aimed at reducing common biological risk factors in the affected individuals. According to Khanal et al., and Otgontuya et al., total disease risk scoring system, like the total CVD and T2DM risk scoring systems, are more accurate in detecting high-risk population who have multiple cardiometabolic risk factors, and most cost-effective for the prevention of both CVDs and T2DM, especially in countries with limited health-care resources.,
Considering the results of the current study and other similar studies, it is strongly advised that the public policymakers should design effective policies and programs that incorporate and emphasis lifestyle intervention in the prevention of CVDs and T2DM in the general population, especially among the high-risk in the community, like the corporate workers. Furthermore, the clinicians should design and implement chronic diseases treatment guideline that emphases the identification and mitigation of the cardiometabolic risk factors primarily through structured and comprehensive lifestyle changes and monitor the progress of the treatment through the risk scoring systems. The future researches should investigate and design measures that focus on the specific clinical and nonclinical lifestyle intervention programs that can be implemented in the effective treatment, and when possible, reversal of the rising prevalence of CVDs, T2DM, and other NCDs.
A few limitations are worthy of note. Some of the participants, due to their busy schedules, find it extremely difficult to concentrate fully throughout the 12 weeks of intervention. Toward the end of the program, few of the participants complained of loss of interest and reduced motivation to continue with the study.
The results of this study further affirm the findings of some researchers, such as McGuire et al., Rankin et al., and Yamaoka et al., This study and other similar studies also demonstrate that lifestyle intervention programs are effective and can be adopted effectively among different clusters of people in the community in the reduction of most cardiometabolic risk factors.
| Conclusion|| |
The results of the study reveal that a 12-week lifestyle education is an effective intervention program to significantly improve the attitude of corporate workforce toward healthy living; improve certain lifestyle practices (frequency of fruits and vegetable consumption, physical activity, tobacco use, and alcohol consumption), reduce biophysical (blood pressure, BMI, waist circumference, resting heart rate), and biochemical (FBG and TBC) profiles, and T2DM risk scores. As a measure to reduce the risk of developing CVDs and T2DM among the corporate workforce, a workplace health promotion program that targets the cardiometabolic risk factors, primarily through risk assessment, health seminars, social media communication, and behavioral change should be adopted by every corporate organization, and other human clusters.
A single author responsible for conception, conduct and reporting of the study.
Financial support and sponsorship
Conflict of interest
There are no conflicts of interest.
Compliance with ethical principles
All the procedures of the study were in accordance with the ethical standards on human experimentation in Nigeria and with the Helsinki Declaration of 1975, as revised in 2000. Before its commencement, the proposal of the study was separately reviewed, corrected, and approved by the ethical committees of both the National Health Research Ethics Committee of Nigeria and the National Hospital, Abuja.
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[Table 1], [Table 2], [Table 3], [Table 4]