Healthcare, Vol. 11, Pages 91: Virtual Behavioral Intervention to Promote Healthy Lifestyle Behaviors: A Feasibility RCT during COVID-19 Pandemic

1. IntroductionSARS-CoV-2 (COVID-19) mainly affects the respiratory system and can lead to life-threating complications [1,2]. Further, there is no promising treatment for COVID-19; thus, several countries have instituted a partial or full lockdown to slow down the spread of COVID-19 [3]. In Saudi Arabia, these procedures included switching to distance learning, working from home and limiting clinical visits [4]. The restrictions that occur in regular daily life due to the implemented isolation measures may increase the difficulty of adopting a healthy lifestyle.The impact of the COVID-19 pandemic has shown associations with mental and psychological health [5,6]. Restrictions to normal daily life before the COVID-19 era have been associated with worse psychological wellbeing [7,8,9]. Previous studies reported poorer wellbeing for people who feel isolated, have a fear of contracting a dangerous virus or practiced social distancing [10,11,12,13]. In addition, time spent in quarantine has been positively linked with more symptoms of stress, anxiety and depression [14,15,16]. Therefore, people with different health issues might face excessive worries about their health and limit their engagement in healthy lifestyle behaviors.Healthy lifestyle behaviors include being physically active, practicing healthy eating habits, having a good quality sleep duration, reducing stress levels, engaging in positive social connections and avoiding substance abuse [17]. Engaging in one or more of the opposite healthy lifestyle behaviors (unhealthy lifestyle behaviors) has been associated with an increased risk of cardiovascular diseases and metabolic disorders incidence rate [18,19]. Further, it has been associated with higher all-cause mortality [20]. Overall, unhealthy lifestyle behaviors have contributed greatly to increasing the global health and economic burden of chronic disease incidence and complications [21].Several therapeutic options such as health promotion or behavioral change strategies are utilized to enhance a healthy lifestyle. Interventions targeting behavioral changes utilize several theoretical models, one of which is the transtheoretical model [22,23]. In this model, the behavioral change in an individual will undergo five stages of change: precontemplation, contemplation, preparation, action and maintenance. Thus, interventions should identify which stage an individual is currently in to provide targeted strategies of behavioral therapy. Transtheoretical models have been used extensively to induce lifestyle behavioral changes in different populations with encouraging results [24,25,26]. One tool to induce behavioral change based on the transtheoretical model is motivational interviewing (MI). The MI goal is to support an individual’s effort in changing their behavior through building intrinsic motivation and clearing any indecisiveness [27]. MI has been used successfully in healthcare [28].

Strategies to prevent unhealthy lifestyle behaviors during lockdown are imperative to promote physical, mental and psychological health. While health organizations have dictated their time to establish vaccinations to minimize the risk of COVID-19, applying effective procedures to optimize lifestyles is warranted. Improving step counts, sleep duration and diet are important elements in lifestyle behaviors to increase immunity against viruses. However, with restricted physical communication during quarantine, several health organizations delivered health services virtually or online. This quick transition might show challenges to clients or health providers, in which future studies are needed to measure the perception of change in lifestyle behaviors using virtual health services.

Studies exploring the use of behavioral change interventions to improve lifestyle behaviors in Saudi Arabia are scarce [29,30]. Further, health services delivered virtually or online are relatively new in practice in the region. Thus, before launching a full-scale RCT of a virtual behavioral intervention to promote healthy lifestyle behaviors, it is imperative to test the feasibility of conducting such a study. Therefore, this study aimed to investigate the feasibility of a virtual behavioral intervention to promote lifestyle behaviors during the COVID-19 pandemic. 4. Discussion

In this study, people in both groups showed similar attrition rates, technical issues and satisfaction levels. Further, people who received the MI (intervention) showed higher improvements in physical activity, distress and fear of COVID-19 compared to people who received a brief healthy lifestyle promotion (attention). The overall sedentary behavior was approximately reduced by 2 hours in the intervention group compared to a half an hour reduction in the control group, although this comparison was not statically significant. To our knowledge, this is the first randomized control trial that was conducted during the COVID-19 pandemic for a Saudi population.

Online motivational programs during the COVID-19 pandemic were recommended to control the spread of the virus and minimize contact with healthcare professionals [42]. However, there is a need to assure the feasibility of these programs for quality assurance and appropriate designs [43]. We found that people who were engaged in the MI intervention had a 22.2% dropout rate compared to a 21.7% dropout rate for people who received the attention control. Previous studies found that telehealth in physical activity education had a 34% attrition rate [44]. In addition, a meta-analysis study showed a slight increase in the attrition rate of health behavior change trials compared to control groups, which might have been because of the demands to change behaviors and blindness problems [45]. There were no significant differences in the technical issue and satisfaction level between groups. Nonetheless, there were a number of technical issues in both groups that might be a contributing factor to the attrition rate and satisfaction level. Although this study used efficient technology and adapted communication to assure the delivery of interventions, other factors such as the environment, motivation, quality assessment, utilization and implementation need to be considered for future work [46]. Lastly, we could not accurately differentiate between how many participants refused video calls and chose to receive the sessions via phone calls vs. who received phone calls due to technical issues. Thus, in any future RCT with a similar methodology, we recommend that the authors keep accurate details to explore the acceptance rate of utilizing video calls as a healthcare delivery option. Physical activity is an essential element for a healthy lifestyle. The COVID-19 crisis limits individuals from all populations from performing daily physical activities in their daily life, which can be overcome with flexible MI and health promotion approaches that are provided virtually [47]. Our results indicated that physical activity levels increased in participants who received the MI intervention compared to participants who only received attention. Previous research showed that when participants were given the chance to set their individualized behavioral goals, similar to our study, they were more likely to succeed in increasing their physical activity level [48]. Further, our findings were consistent with studies that targeted physical activity behavioral changes through behavioral change models via telephone/internet interventions in different geographic regions [49,50]. Although changing sedentary behavior was not significant between groups, there was large reduction (i.e., 105 min.) in the intervention group compared to the control group (i.e., 45 min.). This might have been due to the low sample size or the actual subjectivity effectiveness, which should be considered for future studies. Consistently, in a community-based study, there was a reduction in the sitting time (i.e., 2.9% of the baseline) for the people who received theory-based counseling sessions, which was not significant when compared to the people who received usual lifestyle education [51]. Inconsistent with our findings, a pilot study found that older adults who received 6 weeks of a telehealth program that emphasized physical activity showed no improvement in physical activity and sitting duration during the COVID-19 pandemic. Our design and methodological aspects avoided several limitations that were present in the referenced pilot study, including no control group, a low sample size, high chances of comorbidities and a lack of feasibility data.

Promoting sleep quality and quantity is essential for a better quality of life. Sleep duration increased by approximately half an hour and the sleep quality improved by a score of 0.8 on the PSQI for the experimental group, though these changes were not significant within nor between the groups. Most of the participants were at the normal cut-off of sleep quality, which might explain the small effect size of the interventions. People in the experimental program showed an improvement trend in the PSQI, although there were only 21 subjects involved in this program. Previous studies showed the clinically meaningful difference in the PSQI scores ranging from 1.4 to 4 using several statistical approaches. Due to the nature of behavioral intervention studies, there is a need to recruit people with poor sleep quality to find a minimal importance difference. People in the attention control group had normal cutoff PSQI scores (i.e., >5), which might explain the low chance to find significant changes between the groups for this study. For future studies, increasing the sample size might overcome this limitation and improve our standing regarding the effectiveness of the current intervention.

This study has several limitations that need to be considered in future studies. The control group received an online educational program but not the same amount of attention, which might influence the subjectivity of the outcomes in this work. Future work needs to include objective measurements of physical activity, sleep quality and sedentary behavior using accelerometers. Blinding the intervention providers and participants is challenging in clinical trials. Due to the nature of this pilot RCT, blinding the intervention providers and participants was difficult; a large fund might allow future studies to have high-quality designs. Follow-up sessions are needed to assess the continuity of lifestyle improvements or maintenance. One of the important elements of pilot studies is to measure the power of the sample size for future studies based on the outcome of interest. This pilot RCT will guarantee essential information for power calculations by controlling for attrition rate and extraneous variables based on the design of future studies.

Using virtual behavioral interventions to promote a healthy lifestyle is a promising therapeutic approach globally. Further, the high economic and health burden of chronic diseases in this region calls for the exploration of cost-effective therapeutic approaches. This study assessed the first step in achieving this goal. We found that virtual behavioral interventions are feasible in our region for the public. Future studies may investigate the effectiveness of such an approach in people at risk of developing chronic diseases or that have already been diagnosed to reduce the complications rate.

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