Dataset Information

Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study).

ABSTRACT:

Background

Mobile 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.

Objective

This 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.

Methods

A 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.

Results

The 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).

Conclusions

The 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 registration

Clinicaltrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614.

International registered report identifier (irrid)

RR2-10.1097/MD.0000000000009633.

SUBMITTER: Lugones-Sanchez C

PROVIDER: S-EPMC7728540 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study).

Lugones-Sanchez Cristina C Sanchez-Calavera Maria Antonia MA Repiso-Gento Irene I Adalia Esther G EG Ramirez-Manent J Ignacio JI Agudo-Conde Cristina C Rodriguez-Sanchez Emiliano E Gomez-Marcos Manuel Angel MA Recio-Rodriguez Jose I JI Garcia-Ortiz Luis L

JMIR mHealth and uHealth 20201126 11

<h4>Background</h4>Mobile 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.<h4>Objective</h4>This study aimed to assess the short-term (3 months) effectiveness of a mobile app and a smart band for losing weight and changing body com ...[more]

PMID: 33242020

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Project description:BackgroundmHealth technologies could help to improve cardiovascular health; however, their effect on arterial stiffness and hemodynamic parameters has not been explored to date.ObjectiveTo 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.MethodsRandomised 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.ResultsOf 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.ConclusionsIn 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.

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:BACKGROUND:More 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. OBJECTIVE:The 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. METHODS:We 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. RESULTS:The 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). CONCLUSIONS:The 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 REGISTRATION:ClinicalTrials.gov NCT02016014; http://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/760i8EL8Q).

Project description:Mobile technology, when included within multicomponent interventions, could contribute to more effective weight loss. The objective of this project is to assess the impact of adding the use of the EVIDENT 3 application, designed to promote healthy living habits, to traditional modification strategies employed for weight loss. Other targeted behaviors (walking, caloric-intake, sitting time) and outcomes (quality of life, inflammatory markers, measurements of arterial aging) will also be evaluated.Randomized, multicentre clinical trial with 2 parallel groups. The study will be conducted in the primary care setting and will include 700 subjects 20 to 65 years, with a body mass index (27.5-40?kg/m), who are clinically classified as sedentary. The primary outcome will be weight loss. Secondary outcomes will include change in walking (steps/d), sitting time (min/wk), caloric intake (kcal/d), quality of life, arterial aging (augmentation index), and pro-inflammatory marker levels. Outcomes will be measured at baseline, after 3 months, and after 1 year. Participants will be randomly assigned to either the intervention group (IG) or the control group (CG). Both groups will receive the traditional primary care lifestyle counseling prior to randomization. The subjects in the IG will be lent a smartphone and a smartband for a 3-month period, corresponding to the length of the intervention. The EVIDENT 3 application integrates the information collected by the smartband on physical activity and the self-reported information by participants on daily food intake. Using this information, the application generates recommendations and personalized goals for weight loss.There is a great diversity in the applications used obtaining different results on lifestyle improvement and weight loss. The populations studied are not homogeneous and generate different results. The results of this study will help our understanding of the efficacy of new technologies, combined with traditional counseling, towards reducing obesity and enabling healthier lifestyles.The study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca ("CREC of Health Area of Salamanca") on April 2016. A SPIRIT checklist is available for this protocol. The trial was registered in ClinicalTrials.gov provided by the US National Library of Medicine-number NCT03175614.

Project description:BackgroundOverweight and obesity have been linked to several serious health problems and medical conditions. With more than a quarter of the young population having weight problems, the impacts of overweight and obesity on this age group are particularly critical. Mobile health (mHealth) apps that support and encourage positive health behaviors have the potential to achieve better health outcomes. These apps represent a unique opportunity for young people (age range 10-24 years), for whom mobile phones are an indispensable part of their everyday living. However, despite the potential of mHealth apps for improved engagement in health interventions, user adherence to these health interventions in the long term is low.ObjectiveThe aims of this research were to (1) review and analyze mHealth apps targeting obesity and overweight and (2) propose guidelines for the inclusion of user interface design patterns (UIDPs) in the development of mHealth apps for obese young people that maximizes the impact and retention of behavior change techniques (BCTs).MethodsA search for apps was conducted in Google Play Store using the following search string: ["best weight loss app for obese teens 2020"] OR ["obesity applications for teens"] OR ["popular weight loss applications"]. The most popular apps available in both Google Play and Apple App Store that fulfilled the requirements within the inclusion criteria were selected for further analysis. The designs of 17 mHealth apps were analyzed for the inclusion of BCTs supported by various UIDPs. Based on the results of the analysis, BCT-UI design guidelines were developed. The usability of the guidelines was presented using a prototype app.ResultsThe results of our analysis showed that only half of the BCTs are implemented in the reviewed apps, with a subset of those BCTs being supported by UIDPs. Based on these findings, we propose design guidelines that associate the BCTs with UIDPs. The focus of our guidelines is the implementation of BCTs using design patterns that are impactful for the young people demographics. The UIDPs are classified into 6 categories, with each BCT having one or more design patterns appropriate for its implementation. The applicability of the proposed guidelines is presented by mock-ups of the mHealth app "Morphe," intended for young people (age range 10-24 years). The presented use cases showcase the 5 main functionalities of Morphe: learn, challenge, statistics, social interaction, and settings.ConclusionsThe app analysis results showed that the implementation of BCTs using UIDPs is underutilized. The purposed guidelines will help developers in designing mHealth apps for young people that are easy to use and support behavior change. Future steps involve the development and deployment of the Morphe app and the validation of its usability and effectiveness.

Project description:BACKGROUND:Technology-in particular, access to the Internet from a mobile device-has forever changed the way we relate to others and how we behave in our daily life settings. In recent years, studies have been carried out to analyze the effectiveness of different actions via mobile phone in the field of health: telephone calls, short message service (SMS), telemedicine, and, more recently, the use of push notifications. We have continued to explore ways to increase user interaction with mobile apps, one of the pending subjects in the area of mHealth. By analyzing the data produced by subjects during a clinical trial, we were able to extract behavior patterns and, according to them, design effective protocols in weight loss programs. OBJECTIVE:A clinical trial was proposed to (1) evaluate the efficacy of push notifications in an intervention aimed at improving the body composition of adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA). METHODS:A two-arm randomized controlled trial was carried out. A sample size of 117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months. All patients were supplied with an app designed for this study and a pedometer. The control group did not have access to functionalities related to the self-monitoring of weight at home, gamification, or prescription of PA. The intervention group members were assigned objectives to achieve a degree of compliance with diet and PA through exclusive access to specific functionalities of the app and push notifications. The same diet was prescribed for all patients. Three possible PA scenarios were studied for both the control and intervention groups: light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA). For the analysis of three or more means, the analysis of variance (ANOVA) of repeated means was performed to evaluate the effects of the intervention at baseline and at 3 and 6 months. RESULTS:Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; P<.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; P<.018). These variations between groups led to a nonsignificant difference in weight loss (mean -7.9 kg [SD 3.9] in the intervention group vs mean -7.1 kg [SD 3.4] in the control group; P>.05). CONCLUSIONS:Push notifications have proven effective in the proposed weight loss program, leading women who received them to achieve greater loss of fat mass and a maintenance or increase of muscle mass, specifically among those who followed a program of IPA. Future interventions should include a longer evaluation period; the impact of different message contents, as well as message delivery times and frequency, should also be researched. TRIAL REGISTRATION:ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583.

Project description:BACKGROUND:Traditional dietary recommendations for achieving optimal gestational weight gain are ineffective for pregnant women due to the lack of real-time communication and tedious consultation processes. OBJECTIVE:In this pilot study, we aimed to determine the feasibility of a novel food-coaching smartphone app for controlling gestational weight gain and macronutrient intake among overweight and obese pregnant women. METHODS:We designed a randomized controlled trial and recruited 30 overweight and obese pregnant women (1:1 ratio) during 18-20 weeks of gestation and followed them up after 4 and 8 weeks, respectively. Both groups received standard pregnancy dietary orientation at recruitment, while the intervention group received 8 weeks of real-time food coaching via a smartphone app. This food-coaching smartphone app (Glycoleap, Holmusk, Singapore) aimed to improve care and outcomes for people with diabetes. Pregnant women using this app were able to upload food images (eg, a picture of a meal, a drink, or a dessert) and received real-time and detailed food-coaching comments and guidance provided by professional dietitians during the day (8 AM to 8 PM). We recorded detailed characteristics during recruitment and examined anthropometry at all visits. We compared the mean differences of the 8-week gestational weight gain and macronutrient intake between the two groups. RESULTS:Upon study completion, three subjects dropped out from the intervention, and one gave birth prematurely in the control group. The acceptance rate of the smartphone app was 90%. More participants achieved optimal gestational weight gain per week in the intervention group (8/12, 67%) than in the control group (5/14, 36%). After the 8-week intervention, women in the intervention group appeared to have lower gestational weight gain (mean difference=-0.08 kg; 95% CI -1.80 to 1.63) and cholesterol intake (mean difference=-31.73 mg; 95% CI -102.91 to 39.45) than those in the control group. CONCLUSIONS:Our findings showed that this food-coaching smartphone app is feasible and favorable for weight gain control and cholesterol intake control among overweight and obese pregnant women. Although our results were not significant (perhaps, attributed to the small sample size), it provided proof of concept for the feasibility of applying such technology in future randomized controlled trials with a larger sample size, an earlier intervention onset, and a longer follow-up for overweight and obese pregnant women.

Project description:BackgroundWalking therapy improves functional outcomes in patients with peripheral artery disease (PAD). Less is known about the additive benefit of a dietary intervention.ObjectiveOur objectives were to develop a smartphone app and, as a pilot, explore its potential efficacy as compared to motivational interviewing (MI) to increase walking distance and promote weight loss in overweight/obese adults with PAD.MethodsWe conducted a 3-month, 2-arm randomized pilot study at the University of Kansas. Inclusion criteria were BMI >27 kg/m2 and symptomatic PAD, defined by an ankle-brachial index <0.9. Patients were randomized into 2 groups: MI, delivered through in-person and telephone counseling, and app, a mobile smartphone app. Both interventions encouraged walking for exercise and healthy dietary habits (increasing fruits and vegetables and whole grains while reducing fat and sugary drinks). We assessed medical history at baseline. At baseline and 3 months, participants completed an assessment of 6-minute walking distance, weight, quality of life, exercise behaviors, and dietary habits. The primary outcome was 3-month change in walking distance. Secondary outcomes were changes in weight, quality of life, exercise behaviors, and dietary habits. We used a Wilcoxon rank-sum test to analyze the primary and secondary outcomes at 3 months within the MI and app groups and to compare the changes between the groups with adjustment for baseline.ResultsWe randomized 29 participants with a mean age of 66.03 (SD 8.12) years; 25 participants completed the trial. At baseline, mean walking distance among completers was 260.40 (SD 94.32) meters and 326.15 (SD 69.28) meters for MI and app participants, respectively. At 3 months, the mean walking distance was 298.67 (SD 101.20) meters and 331.19 (SD 58.63) meters for MI and app participants, respectively (group difference P=.03, adjusting for baseline). Increase in walking distance at 3 months was 40.5 meters (95% CI 6.77 to 61.34; P=.02) in MI group. At baseline, mean body weight was 253.10 (SD 59.45) lbs and 225.13 (SD 58.93) lbs for MI and app participants, respectively. At 3 months, mean body weight was 242.14 (SD 58.54) lbs and 223.44 (SD 59.54) lbs for MI and app, respectively (group difference P=.006, adjusting for baseline). Pre-post study decrease in weight was 10.1 lbs (95% CI -17.9 to -3.0) and 2.3 lbs (95% CI -3.4 to -0.7) in MI and app group, respectively. Comparing baseline to 3 months, there were no statistically significant differences in quality of life, exercise behaviors, or dietary habits.ConclusionsOur study demonstrates that MI can promote walking and weight loss in overweight/obese adults with PAD. The smartphone app showed a small weight loss but no statistically significant increase in walking distance. As this was a pilot study, future large-scale studies are needed to replicate the efficacy of MI to promote weight loss in overweight or obese adults with PAD.Trial registrationClinicalTrials.gov NCT03694652; https://clinicaltrials.gov/ct2/show/NCT03694652.

Dataset Information

Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study).

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study).

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