Dataset Information

Long-Term Effectiveness of a Smartphone App and a Smart Band on Arterial Stiffness and Central Hemodynamic Parameters in a Population with Overweight and Obesity (Evident 3 Study): Randomised Controlled Trial.

ABSTRACT:

Background

mHealth technologies could help to improve cardiovascular health; however, their effect on arterial stiffness and hemodynamic parameters has not been explored to date.

Objective

To evaluate the effect of a mHealth intervention, at 3 and 12 months, on arterial stiffness and central hemodynamic parameters in a sedentary population with overweight and obesity.

Methods

Randomised controlled clinical trial (Evident 3 study). 253 subjects were included: 127 in the intervention group (IG) and 126 in the control group (CG). The IG subjects were briefed on the use of the Evident 3 app and a smart band (Mi Band 2, Xiaomi) for 3 months to promote healthy lifestyles. All measurements were recorded in the baseline visit and at 3 and 12 months. The carotid-femoral pulse wave velocity (cfPWV) and the central hemodynamic parameters were measured using a SphigmoCor System^® device, whereas the brachial-ankle pulse wave velocity (baPWV) and the Cardio Ankle Vascular Index (CAVI) were measured using a VaSera VS-2000^® device.

Results

Of the 253 subjects who attended the initial visit, 237 (93.7%) completed the visit at 3 months of the intervention, and 217 (85.3%) completed the visit at 12 months of the intervention. At 12 months, IG showed a decrease in peripheral augmentation index (PAIx) (-3.60; 95% CI -7.22 to -0.00) and ejection duration (ED) (-0.82; 95% CI -1.36 to -0.27), and an increase in subendocardial viability ratio (SEVR) (5.31; 95% CI 1.18 to 9.44). In CG, cfPWV decreased at 3 months (-0.28 m/s; 95% CI -0.54 to -0.02) and at 12 months (-0.30 m/s, 95% CI -0.54 to -0.05), central diastolic pressure (cDBP) decreased at 12 months (-1.64 mm/Hg; 95% CI -3.19 to -0.10). When comparing the groups we found no differences between any variables analyzed.

Conclusions

In sedentary adults with overweight or obesity, the multicomponent intervention (Smartphone app and an activity-tracking band) for 3 months did not modify arterial stiffness or the central hemodynamic parameters, with respect to the control group. However, at 12 months, CG presented a decrease of cfPWV and cDBP, whereas IG showed a decrease of PAIx and ED and an increase of SEVR.

SUBMITTER: Gomez-Sanchez L

PROVIDER: S-EPMC9695348 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Long-Term Effectiveness of a Smartphone App and a Smart Band on Arterial Stiffness and Central Hemodynamic Parameters in a Population with Overweight and Obesity (Evident 3 Study): Randomised Controlled Trial.

Gómez-Sánchez Leticia L Gómez-Sánchez Marta M Lugones-Sánchez Cristina C Rodríguez-Sánchez Emiliano E Tamayo-Morales Olaya O Gonzalez-Sánchez Susana S Magallón-Botaya Rosa R Ramirez-Manent Jose Ignacio JI Recio-Rodriguez Jose I JI Agudo-Conde Cristina C García-Ortiz Luis L Gómez-Marcos Manuel A MA

Nutrients 20221110 22

<h4>Background</h4>mHealth technologies could help to improve cardiovascular health; however, their effect on arterial stiffness and hemodynamic parameters has not been explored to date.<h4>Objective</h4>To evaluate the effect of a mHealth intervention, at 3 and 12 months, on arterial stiffness and central hemodynamic parameters in a sedentary population with overweight and obesity.<h4>Methods</h4>Randomised controlled clinical trial (Evident 3 study). 253 subjects were included: 127 in the inte ...[more]

PMID: 36432446

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Project description:BackgroundMobile health (mHealth) is currently among the supporting elements that may contribute to an improvement in health markers by helping people adopt healthier lifestyles. mHealth interventions have been widely reported to achieve greater weight loss than other approaches, but their effect on body composition remains unclear.ObjectiveThis study aimed to assess the short-term (3 months) effectiveness of a mobile app and a smart band for losing weight and changing body composition in sedentary Spanish adults who are overweight or obese.MethodsA randomized controlled, multicenter clinical trial was conducted involving the participation of 440 subjects from primary care centers, with 231 subjects in the intervention group (IG; counselling with smartphone app and smart band) and 209 in the control group (CG; counselling only). Both groups were counselled about healthy diet and physical activity. For the 3-month intervention period, the IG was trained to use a smartphone app that involved self-monitoring and tailored feedback, as well as a smart band that recorded daily physical activity (Mi Band 2, Xiaomi). Body composition was measured using the InBody 230 bioimpedance device (InBody Co., Ltd), and physical activity was measured using the International Physical Activity Questionnaire.ResultsThe mHealth intervention produced a greater loss of body weight (-1.97 kg, 95% CI -2.39 to -1.54) relative to standard counselling at 3 months (-1.13 kg, 95% CI -1.56 to -0.69). Comparing groups, the IG achieved a weight loss of 0.84 kg more than the CG at 3 months. The IG showed a decrease in body fat mass (BFM; -1.84 kg, 95% CI -2.48 to -1.20), percentage of body fat (PBF; -1.22%, 95% CI -1.82% to 0.62%), and BMI (-0.77 kg/m2, 95% CI -0.96 to 0.57). No significant changes were observed in any of these parameters in men; among women, there was a significant decrease in BMI in the IG compared with the CG. When subjects were grouped according to baseline BMI, the overweight group experienced a change in BFM of -1.18 kg (95% CI -2.30 to -0.06) and BMI of -0.47 kg/m2 (95% CI -0.80 to -0.13), whereas the obese group only experienced a change in BMI of -0.53 kg/m2 (95% CI -0.86 to -0.19). When the data were analyzed according to physical activity, the moderate-vigorous physical activity group showed significant changes in BFM of -1.03 kg (95% CI -1.74 to -0.33), PBF of -0.76% (95% CI -1.32% to -0.20%), and BMI of -0.5 kg/m2 (95% CI -0.83 to -0.19).ConclusionsThe results from this multicenter, randomized controlled clinical trial study show that compared with standard counselling alone, adding a self-reported app and a smart band obtained beneficial results in terms of weight loss and a reduction in BFM and PBF in female subjects with a BMI less than 30 kg/m2 and a moderate-vigorous physical activity level. Nevertheless, further studies are needed to ensure that this profile benefits more than others from this intervention and to investigate modifications of this intervention to achieve a global effect.Trial registrationClinicaltrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614.International registered report identifier (irrid)RR2-10.1097/MD.0000000000009633.

Project description:BackgroundMulticomponent mobile health approaches can improve lifestyle intervention results, although little is known about their long-term effectiveness.ObjectiveThis study aims to evaluate the long-term effectiveness (12 months) of a multicomponent mobile health intervention-combining a smartphone app, an activity tracker wristband, and brief counseling, compared with a brief counseling group only-on weight loss and improving body composition, physical activity, and caloric intake in Spanish sedentary adults with overweight or obesity.MethodsWe conducted a randomized controlled, multicenter clinical trial (Evident 3). A total of 650 participants were recruited from 5 primary care centers, with 318 participants in the intervention group (IG) and 332 in the control group (CG). All participants were briefly counseled about a healthy diet and physical activity at the baseline visit. For the 3-month intervention period, the IG received training to use the app to promote healthy lifestyles and the smart band (Mi Band 2, Xiaomi). All measurements were performed at baseline and at 3 and 12 months. Physical activity was measured using the International Physical Activity Questionnaire-Short Form. Nutritional habits were assessed using the Food Frequency Questionnaire and Adherence to Mediterranean diet questionnaire.ResultsOf the 650 participants included, 563 (86.6%) completed the 3-month visit and 443 (68.2%) completed the 12-month visit. After 12 months, the IG showed net differences in weight (-0.26, 95% CI -1.21 to 0.70 kg; P=.02), BMI (-0.06, 95% CI -0.41 to 0.28 points; P=.01), waist-height ratio (-0.25, 95% CI -0.94 to 0.44; P=.03), body adiposity index (-0.33, 95% CI -0.77 to 0.11; P=.03), waist circumference (-0.48, 95% CI -1.62 to 0.66 cm, P=.04) and hip circumference (-0.69, 95% CI -1.62 to 0.25 cm; P=.03). Both groups lowered daily caloric intake and increased adherence to the Mediterranean diet, with no differences between the groups. The IG increased light physical activity time (32.6, 95% CI -30.3 to 95.04 min/week; P=.02) compared with the CG. Analyses by subgroup showed changes in body composition variables in women, people aged >50 years, and married people.ConclusionsThe low-intensity intervention of the Evident 3 study showed, in the IG, benefits in weight loss, some body composition variables, and time spent in light physical activity compared with the CG at 3 months, but once the devices were collected, the downward trend was not maintained at the 12-month follow-up. No differences in nutritional outcomes were observed between the groups.Trial registrationClinicalTrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614.International registered report identifier (irrid)RR2-10.1097/MD.0000000000009633.

Project description:BACKGROUND:Although distress screening is crucial for cancer survivors, it is not easy for clinicians to recognize distress. Physical activity (PA) data collected by mobile devices such as smart bands and smartphone apps have the potential to be used to screen distress in breast cancer survivors. OBJECTIVE:The aim of this study was to assess data collection rates of smartphone apps and smart bands in terms of PA data, investigate the correlation between PA data from mobile devices and distress-related questionnaires from smartphone apps, and demonstrate factors associated with data collection with smart bands and smartphone apps in breast cancer survivors. METHODS:In this prospective observational study, patients who underwent surgery for breast cancer at Asan Medical Center, Seoul, Republic of Korea, between June 2017 and March 2018 were enrolled and asked to use both a smartphone app and smart band for 6 months. The overall compliance rates of the daily PA data collection via the smartphone walking apps and wearable smart bands were analyzed in a within-subject manner. The longitudinal daily collection rates were calculated to examine the dropout pattern. We also performed multivariate linear regression analysis to examine factors associated with compliance with daily collection. Finally, we tested the correlation between the count of daily average steps and distress level using Pearson correlation analysis. RESULTS:A total of 160 female patients who underwent breast cancer surgeries were enrolled. The overall compliance rates for using a smartphone app and smart bands were 88.0% (24,224/27,513) and 52.5% (14,431/27,513), respectively. The longitudinal compliance rate for smartphone apps was 77.8% at day 180, while the longitudinal compliance rate for smart bands rapidly decreased over time, reaching 17.5% at day 180. Subjects who were young, with other comorbidities, or receiving antihormonal therapy or targeted therapy showed significantly higher compliance rates to the smartphone app. However, no factor was associated with the compliance rate to the smart band. In terms of the correlation between the count of daily steps and distress level, step counts collected via smart band showed a significant correlation with distress level. CONCLUSIONS:Smartphone apps or smart bands are feasible tools to collect data on the physical activity of breast cancer survivors. PA data from mobile devices are correlated with participants' distress data, which suggests the potential role of mobile devices in the management of distress in breast cancer survivors. TRIAL REGISTRATION:ClinicalTrials.gov NCT03072966; https://clinicaltrials.gov/ct2/show/NCT03072966.

Project description:PurposeThis study aimed to assess the effects of exercise with dietary restriction on arterial stiffness, central hemodynamics, and cardiac autonomic function in obese adolescents.Patients and methodsTwenty-one obese adolescents completed a 6-week exercise and dietary program. Body composition and metabolic parameters were measured. Carotid-femoral pulse wave velocity (cfPWV) and brachial-ankle pulse wave velocity (baPWV) were used to assess central and systemic arterial stiffness, respectively. Using applanation tonometry, the analyses of central hemodynamic parameters [central blood pressure, heart rate (HR), augmentation index normalized at 75 bpm (AIx75), and subendocardial viability ratio (SEVR)] were performed. To determine cardiac autonomic function, heart rate variability (HRV) was analyzed by standard deviation of normal R-R intervals (SDNN), root mean square of successive R-R interval differences (RMSSD), percentage of successive R-R intervals that differed by >50 ms (pNN50), total power (TP), low-frequency (LF) and high-frequency (HF) power, and LF/HF ratio.ResultsFollowing the intervention, obese adolescents had reductions in body mass index, body fat percentage, brachial systolic and diastolic blood pressure, and HR; and they had shown improvements in lipid profiles. There were reductions in both cfPWV and baPWV following the intervention. Moreover, there were reductions in AIx75, aortic systolic and diastolic blood pressure and an augmentation in SEVR after intervention. The intervention increased cardiac autonomic function (determined by increased SDNN, RMSSD, pNN50, HF, and reduced LF/HF). Furthermore, we observed a correlation between increased cardiac autonomic function (SDNN, RMSSD, pNN50 and HF) and increased central hemodynamics, as measured by SEVR and AIx75.ConclusionObese adolescents had increased central hemodynamics and autonomic function with reduced arterial stiffness after exercise and dietary restriction. Moreover, a positive correlation between an enhancement of cardiac autonomic function and an augmentation in central hemodynamics was found after the intervention.

Project description:BackgroundMore alternatives are needed for recording people's normal diet in different populations, especially adults or the elderly, as part of the investigation into the effects of nutrition on health.ObjectiveThe aim of this study was to compare the estimated values of energy intake, macro- and micronutrient, and alcohol consumption gathered using the EVIDENT II smartphone app against the data estimated with a food frequency questionnaire (FFQ) in an adult population aged 18 to 70 years.MethodsWe included 362 individuals (mean age 52 years, SD 12; 214/362, 59.1% women) who were part of the EVIDENT II study. The participants registered their food intake using the EVIDENT app during a period of 3 months and through an FFQ. Both methods estimate the average nutritional composition, including energy intake, macro- and micronutrients, and alcohol. Through the app, the values of the first week of food recording, the first month, and the entire 3-month period were estimated. The FFQ gathers data regarding the food intake of the year before the moment of interview.ResultsThe intraclass correlation for the estimation of energy intake with the FFQ and the app shows significant results, with the highest values returned when analyzing the app's data for the full 3-month period (.304, 95% CI 0.144-0.434; P<.001). For this period, the correlation coefficient for energy intake is .233 (P<.001). The highest value corresponds to alcohol consumption and the lowest to the intake of polyunsaturated fatty acids (r=.676 and r=.155; P<.001), respectively. The estimation of daily intake of energy, macronutrients, and alcohol presents higher values in the FFQ compared with the EVIDENT app data. Considering the values recorded during the 3-month period, the FFQ for energy intake estimation (Kcal) was higher than that of the app (a difference of 408.7, 95% CI 322.7-494.8; P<.001). The same is true for the other macronutrients, with the exception g/day of saturated fatty acids (.4, 95% CI -1.2 to 2.0; P=.62).ConclusionsThe EVIDENT app is significantly correlated to FFQ in the estimation of energy intake, macro- and micronutrients, and alcohol consumption. This correlation increases with longer app recording periods. The EVIDENT app can be a good alternative for recording food intake in the context of longitudinal or intervention studies.Trial registrationClinicalTrials.gov NCT02016014; http://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/760i8EL8Q).

Project description:Objective: Arterial stiffness, as determined by pulse wave velocity (PWV), is a recognized marker of cardiovascular risk. Noninvasive technologies have enabled easier and more accessible assessments of PWV. The current gold standard for measuring carotid-femoral PWV (cfPWV)-a reliable indicator of arterial stiffness-utilizes applanation tonometry devices, as recommended by the Artery Society Guidelines. The objective of this study was to compare the performance of various noninvasive arterial stiffness measurement methods, specifically the Mobil-O-Graph and SphygmoCor/SphygmoCor XCEL, and evaluate their alignment with the Artery Society Guidelines for accuracy and reliability. Methods: A comprehensive search was conducted in the PubMed and Scopus databases to identify studies that compared and validated noninvasive PWV measurements, focusing on their repeatability. The search covered studies from inception through March 31, 2024. A total of 2092 papers were identified. Following the selection process, 21 studies met the inclusion criteria. Additionally, 2 more studies, not retrieved by the initial search but deemed relevant from other databases, were included. The included studies focused on populations with chronic diseases who were hemodynamically stable. Studies involving participants in specific conditions, such as pregnancy, hemodynamic shock, or undergoing stress tests, were excluded from the analysis. Results: Several devices have been developed and validated for the noninvasive measurement of arterial stiffness, utilizing applanation tonometry (e.g., SphygmoCor, SphygmoCor XCEL) and cuff-based oscillometry (e.g., Arteriograph, Mobil-O-Graph). The analyses reviewed included studies using both invasive and noninvasive devices. A notable finding was the relative heterogeneity of study populations across different research, with variations in sample size, BMI, sex proportions, and age groups often falling short of guideline recommendations. In most of the included validation studies, the sample sizes were smaller than the minimum recommended by guidelines. Moreover, factors such as BMI, sex distribution, and age group sizes were inconsistent with established standards. Despite these limitations, validation studies comparing invasive and noninvasive methods consistently highlighted the superiority of cfPWV assessment devices. Applanation tonometry devices demonstrated smaller discrepancies in PWV measurements and better overall agreement with invasive methods than oscillometry-based devices. Three studies comparing the SphygmoCor XCEL with the standard SphygmoCor showed an excellent level of agreement, with one study confirming the SphygmoCor XCEL's superior adherence to validation criteria. Oscillometric devices showed a stronger reliance on algorithmic adjustments based on factors such as age and systolic blood pressure. This dependence likely contributes to the underestimation of PWV, particularly in populations with chronic diseases or other conditions promoting arterial stiffness. Despite this, oscillometric devices demonstrated lower PWV variability in short-term repeatability assessments. Conclusions: More research on a larger population should be performed in order to introduce noninvasive devices into daily medical practice.

Dataset Information

Long-Term Effectiveness of a Smartphone App and a Smart Band on Arterial Stiffness and Central Hemodynamic Parameters in a Population with Overweight and Obesity (Evident 3 Study): Randomised Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Publications

Long-Term Effectiveness of a Smartphone App and a Smart Band on Arterial Stiffness and Central Hemodynamic Parameters in a Population with Overweight and Obesity (Evident 3 Study): Randomised Controlled Trial.

Similar Datasets

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