This study indicates that the 29 hypertensive overweight or obese patients enrolled in the reintervention had maintained long-term benefits in terms of reduced BMI and blood pressure at a 3-year follow-up after having completed the ‘Living Better’ online intervention 37,38. Likewise, our results show that these variables significantly improved after the same group of patients repeated the program a second time (reintervention). To the best of our knowledge, this is the first work using a web-based program aimed at promoting a healthy lifestyle based on psychoeducation, regular engagement in physical exercise, and the establishment of healthy eating habits with such a long-term follow-up time. It also appears to be the first study to describe the effects of a reintervention in patients with an obesity-hypertension phenotype.
Our results did not show any significant changes in any of the study variables (SBP, DBP, BMI, number of antihypertensive drugs, or eating behavior) at the 3-year follow-up, compared to the first intervention in 2018, with the exception of the level of physical activity, which had significantly worsened. This decline may have been because of the restrictions to movements and access to sports spaces imposed by governmental authorities as a result of the COVID-19 pandemic at the time of this work. In this sense, recent research indicates that there was a significant decrease in physical activity levels at this time, accompanied by an increase in sedentary habits, due to these restrictions 25,26. However, it is important to note that the IPAQ-Short questionnaire we administered to analyse physical activity levels in this study 42,43 only collected data from the 7 days prior to its completion and, therefore, did not represent the total amount of physical activity these patients had engaged in during the pandemic. Thus, these levels may have fluctuated depending on the prevailing limitations at any given time. Also of note, the eating behavior of the study patients did not significantly worsen during that time. Indeed, the ‘Living Better’ program has already been shown to effectively improve emotional eating and other psychological variables related to eating and quality of life (anxiety and stress) 37. These results are consistent with the absence of significant changes in blood pressure and BMI, together indicating the long-term effectiveness of the ‘Living Better’ program.
Thus, to help deal with the possible negative lifestyle effects of the COVID-19 pandemic on patients with the obesity-hypertension phenotype (for example, decreased physical activity levels), we decided to implement a second intervention with the same program. Given the self-administered, interactive, multimedia, and web-based nature of the platform, we hypothesised that repeating this program could reinforce and enhance the knowledge the patients had acquired after the first intervention, helping them to face the restrictions resulting from the presence of SARS-CoV-2 and thereby perhaps minimising the negative impact of the situation on their lifestyle and health.
The results we obtained after administering the reintervention confirmed our hypothesis. Thus, despite the restrictions imposed by the COVID-19 pandemic, the participants had significantly increased their levels of physical activity ─after 3 months of reintervention─ by about 30%, or around 900 METs-min/week. This may have also translated into an improvement in cardiorespiratory fitness (CRF) as a result of them engaging in moderate-vigorous intensity activities 25,47. Interestingly, CRF is closely and inversely related to all-cause morbidity and mortality 48 and also strongly impacts the prognosis and evolution of patients with COVID-19, even more so in the presence of associated comorbidities such as obesity 25,49 or hypertension 50. Thus, although none of the 29 participants was infected with SARS-CoV-2 before or during the study, the ‘Living Better’ program effectively increased the levels of physical activity of its participants during the COVID-19 pandemic. Hence, if any of these patients had been infected with SARS-CoV-2, the program may have conferred some protective effects by slightly reducing their risk of complications and improving their prognosis.
In addition to the improvements in physical activity levels, as already demonstrated in the first intervention in 2018 37, reintervention with the ‘Living Better’ program also positively influenced emotional eating and external eating. In fact, one of the goals of this program is to change eating behaviors (generating a more conscious and less impulsive eating style) by using psychoeducation, eating tricks, and self-control strategies. This finding is relevant because eating styles are considered to be multi-dimensional, stable, and related to obesity 51. The latter is important in the context of the negative emotions such as anxiety and panic generated by the COVID-19 pandemic, which have been associated with unhealthy eating behaviors in populations with higher rates of obesity 52,53. Furthermore, adherence to the Mediterranean diet before reintervention was close to the upper limit of the ‘medium adherence’ range (8.2 points on the MEDAS questionnaire) 46, perhaps because of the effect of the first intervention. Nonetheless, the reintervention still produced a slight increase in the score by 0.6 points.
Therefore, presumably as a consequence of improvements in physical activity levels and eating behavior after the reintervention, the participants had reduced their body weight by an average of 2 kg, which translated into a significant reduction in BMI by 0.7 kg/m2. Of special note, this BMI reduction was even higher than that achieved after the first intervention in 2018 (0.4 kg/m2) 38. In addition, the literature also reflects the direct impact that weight loss has on blood pressure values 54. In this sense, compared to our first study 38, the SBP and DBP of the reintervened patients also decreased further, possibly as a consequence of the greater BMI reduction. In these patients SBP and DBP decreased by 4.7 and 3.5 mmHg respectively (P=.017 and P=.009), compared to the non-significant reduction in SBP (−2.6 mmHg, P=.15) and the lower reduction in DBP (−2.2 mmHg, P=.05) we reported after the first intervention in 2018. These post-reintervention improvements also exceeded those reported in the meta-analysis by Liu et al. on internet-based lifestyle counselling 34 in which SBP and DBP reduced by a mean 3.8 mmHg and 2.1 mmHg, respectively. Likewise, it is important to note that the improvements we found in this research were not the result of a change in medication because no significant differences were reported in the number of hypertensive drugs used by the participants at any of the timepoints examined.
In terms of program engagement 55, the percentage of participants who completed our entire program was lower (38%) than our first intervention 38 or similar e-counselling lifestyle interventions 56. The low completion rate for the whole program during the reintervention may have been partly because of the limitations caused by the COVID-19 pandemic, perhaps forcing the population to adapt their working hours and spaces as well as reducing the availability of personal time and resources 57,58. This phenomenon may also have been because the participants had remembered some of the educational content from the first intervention, leading them to complete only the modules that they considered necessary. Indeed, two-thirds of the participants completed at least half of the ‘Living Better’ program (5 or more modules). Moreover, the mean participant satisfaction with the reintervention was 1.2 points (out of 10) higher than the average from the first intervention, although this did not reach statistical significance. This difference may be because of the alterations we made to the program presentation by including more audiovisual content 59,60, as suggested by the patients after the first intervention.
At this point, it is important to highlight that the Internet has been shown as an effective means to promote healthy lifestyles in order to help prevent and treat chronic diseases. This is because it can reach more people (including those with limited access to health services or low levels of social support) and it can provide patients with more intensive contact with clinicians at a lower economic cost than conventional face-to-face programs 61,62. Additionally, internet-based platforms can provide immediate, easily accessible, individually tailored (one-on-one), and permanent (accessible at any time) support to patients in the comfort of their own homes. All these advantages were especially relevant in the context of the COVID-19 pandemic which was ongoing while this study was implemented. Therefore, the long-term effects of the web-based ‘Living Better’ program and those obtained after a reintervention with the same program were remarkable and should be scientifically valued. They minimised the profound negative impact of COVID-19 on the health of these patients ─who all had an obesity-hypertension phenotype─ and even managed to improve their health profiles.
Limitations
The main limitation of this study was the absence of a control group. Of note, since the sample size was small—because the study design was a continuation of previous work—and mostly for ethical reasons, all 29 participants were assigned to a single experimental group so that this population, which was especially vulnerable to COVID-19, would receive effective treatment during this work. Although the positive eating behavior, physical activity, BMI, and blood pressure results were similar to those obtained in our previous ‘Living Better’ randomised controlled trial, the absence of a control group must be considered when interpreting the effects of this reintervention. Controls eliminate the alternate explanations of experimental results, especially confounding variables and experimenter bias, enabling investigators to control for threats to validity. In addition, although prior to reintervention we were unable to identify any differences in the variables in the 29 participants and the 76 patients excluded from the study, we cannot rule out the possibility of a selection bias. Finally, the participants were unable to go to the hospital for BMI and blood pressure measurements before and after the reintervention because of the COVID-19 pandemic restrictions. However, this problem was mitigated by having these measurements completed by the same person (a pharmacist or pharmacy assistant) using the same approved devices both times, and strictly following the ESH protocol as in the first intervention. Nonetheless, the people performing the measurements and the devices used were not the same for all the participants.