scholarly journals 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) (Preprint)

2020 ◽  
Author(s):  
Cristina Lugones-Sanchez ◽  
Maria Antonia Sanchez-Calavera ◽  
Irene Repiso-Gento ◽  
Esther G Adalia ◽  
J Ignacio Ramirez-Manent ◽  
...  

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/m<sup>2</sup>, 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/m<sup>2</sup> (95% CI –0.80 to –0.13), whereas the obese group only experienced a change in BMI of –0.53 kg/m<sup>2</sup> (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/m<sup>2</sup> (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/m<sup>2</sup> 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. CLINICALTRIAL Clinicaltrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614. INTERNATIONAL REGISTERED REPORT RR2-10.1097/MD.0000000000009633

10.2196/21771 ◽  
2020 ◽  
Vol 8 (11) ◽  
pp. e21771
Author(s):  
Cristina Lugones-Sanchez ◽  
Maria Antonia Sanchez-Calavera ◽  
Irene Repiso-Gento ◽  
Esther G Adalia ◽  
J Ignacio Ramirez-Manent ◽  
...  

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


Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  

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; <i>P</i>&lt;.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; <i>P</i>&lt;.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; <i>P</i>&gt;.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. CLINICALTRIAL ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583


10.2196/13747 ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. e13747 ◽  
Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  

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


2015 ◽  
Vol 31 (7) ◽  
pp. 1381-1394 ◽  
Author(s):  
Ana Carolina Barco Leme ◽  
Sonia Tucunduva Philippi

The purpose of this article is to describe the study design, protocol, and baseline results of the “Healthy Habits, Healthy Girls” program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.


Author(s):  
Constanza Mosso ◽  
Victoria Halabi ◽  
Tamara Ortiz ◽  
Maria Isabel Hodgson

AbstractThe aim of this study was to assess dietary intake, nutritional status, body composition, and physical activity level in a group of Chilean children and adolescents with Type 1 diabetes mellitus (T1DM), compare these parameters with the recommendations of the International Society for Pediatric and Adolescent Diabetes (ISPAD), and determine the relationships between dietary intake, body composition, and diabetes control.A total of 30 patients with T1DM (aged 15.2±4.0 years) were included. Dietary intake was assessed using a 92-item quantitative food frequency questionnaire. Body composition was determined using dual-energy X-ray densitometry. Physical activity was assessed by means of a survey.The energy intake of these patients was derived from 21.4% protein, 48% carbohydrates, and 31.2% fat. The glycosylated hemoglobin (HbA1c) was significantly correlated with fat as grams per day (r: 0.363, p<0.05) and calories per day (r: 0.364, p<0.05). The mean body fat percentage in females was 31.2% and 20.2% in males (p < 0.01) and the mean amount of physical activity was 4.5±2.7 h per week.The study patients had a higher protein intake than recommended by ISPAD. Dietary carbohydrate intake was rather low, and dietary fat intake was the same as the limits recommended by ISPAD. Diabetic control was significantly correlated with protein, carbohydrates, fat, and sodium intake. The girls in the study had a higher percentage of body fat than the standard recommendations for their age. The level of physical activity was adequate.


2020 ◽  
Author(s):  
Josefina Bertoli ◽  
Ewertton Bezerra ◽  
José Angelo Barela ◽  
Luis Alberto Gobbo ◽  
Cristina Elena Prado Teles Fregonesi ◽  
...  

Introduction: Breast cancer and its treatments lead to several physical and psychological repercussions in the short and long term. Furthermore, breast cancer survivors (BCS) tend to present sedentary behavior, which worsens the aforementioned breast cancer treatment side effects. Physical exercise has been demonstrated to be effective for improving physical and psychological BCS aspects. Therefore, the purpose of this study is to investigate the effects of 24 weeks of supervised Mat Pilates on force production, flexibility, postural control, gait, body composition, pain, cancer related fatigue (CRF), body image, physical activity level, quality of life, and nutritional status in BCS undergoing hormone therapy. Methods and design: The HAPiMat Study is a randomized controlled clinical intervention trial comparing Mat Pilates with a control group. The primary outcomes are force production in different muscle groups, upper and lower limb flexibility, and gait and balance parameters. The secondary outcomes are quality of life, pain, cancer related fatigue, body image, sedentary behavior, functional capacity, physical activity level, nutritional intake, anthropometric measurements, and body composition. The safety of the Mat Pilates intervention and physical assessments are monitored throughout the intervention. Discussion: The strengths of this study are that the Pilates Method is mind-body training, which might ameliorate the side effects of breast cancer treatments, and that our intervention is systematized into sets, with the number of repetitions increased every eight weeks, enabling better results in the physical variables. Moreover, to date, no Pilates studies have focused on BCS undergoing hormone therapy only.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 43-43
Author(s):  
Nicholas Koemel ◽  
Christina Sciarrillo ◽  
Sam Emerson

Abstract Objectives Excessive postprandial lipemia (PPL) following intake of a high-fat meal (HFM) is a risk factor for cardiovascular disease (CVD). We recently observed significantly lesser PPL in more active individuals, irrespective of age. This project examined the association of body composition, glucose control, and dietary intake with postprandial triglycerides (TG) and vascular function in groups that differed by age and physical activity level. Methods We recruited 4 groups of adults: younger active (YA; age 22.1 ± 1.4 y; n = 9), younger inactive (YI; age 22.6 ± 3.7 y; n = 8), older active (OA; age 68.4 ± 7.7 y; n = 8), and older inactive (OI; age 67.7 ± 7.2 y; n = 7). Participants completed a 3-day food record including 2 weekdays and 1 weekend day. Following a 10-hour overnight fast and 2 days of exercise avoidance, participants consumed a HFM (12 kcal/kg; 63% fat, 34% carbohydrate). Serial blood draws were then collected every hour for 6 hours to measure metabolic responses. Vascular function was assessed using flow-mediated dilation (FMD) at baseline (BL), 2-hours, and 4-hours post-meal. Fasting insulin and glycated hemoglobin (HbA1c) were measured pre-meal. Body composition was assessed using bioelectrical impedance analysis (Seca mBCA 514). Results After controlling for physical activity and age via partial correlation, visceral adiposity was associated with TG total area under the curve (P = 0.04; r = 0.38), while body fat % was inversely associated with BL FMD (P = 0.0007; r = −0.50). HOMA-IR was not associated with visceral adiposity or body fat % (P’s ≥ 0.08). Postprandial metabolic and vascular responses were not associated with skeletal muscle mass (P’s ≥ 0.07), fasting insulin (P’s ≥ 0.30), HOMA-IR (P’s ≥ 0.40) or HbA1c (P’s ≥ 0.29). After adjusting for total caloric intake, BL FMD was positively associated with dietary fiber (P = 0.006; r = 0.50) and negatively associated with dietary sugar (P = 0.01; r = −0.46). Conclusions This study identified body fat distribution, sugar, and fiber as correlated factors for postprandial metabolic and vascular responses when also considering age and physical activity. This warrants future studies to examine further the role of these factors in determining PPL and vascular function. Funding Sources This study was funded by the College of Human Sciences at Oklahoma State University.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
A. Hernández-Reyes ◽  
F. Cámara-Martos ◽  
R. Molina-Luque ◽  
M. Romero-Saldaña ◽  
G. Molina-Recio ◽  
...  

Abstract Background There is evidence showing the effectiveness of a hypocaloric diet and the increase in physical activity on weight loss. However, the combined role of these factors, not only on weight loss but also body composition, remains unclear. The purpose of this study was to investigate the effect of a hypocaloric diet on the body composition of obese adult women throughout different degrees of physical activity during a weight loss program. Methods One hundred and seventeen healthy female volunteers were randomly assigned to one of the experimental groups: a control group with a low-level prescription of physical activity (1–4 METs), moderate physical activity group that performed 10.000 steps walking (5–8 METs) and intense physical activity group that trained exercises by at least 70% of VO2max three times a week (> 8 METs). All subjects followed a hypocaloric diet designed with a reduction of 500 kcal/day. Nutritional counseling was provided throughout the study period to help ensure dietary adherence. Results We found no differences in body weight compared to moderate and intense physical activity (ßstand. = − 0.138 vs. ßstand. = − 0.139). Body fat was lower in women following an intense activity (ßstand. = − 0.436) than those with moderate exercise (ßstand. = − 0.231). The high-intense activity also increased muscle mass at the end of the intervention, standing out above the moderate activity (ßstand. = 0.182 vs. ßstand. = 0.008). Conclusions These findings indicate that a hypocaloric diet, without prescription of physical activity, is adequate to lose weight in the short term (12 weeks), but physical activity is vital to modify the body composition in women with obesity. Body fat was lower when women practiced a moderate exercise compared to hypocaloric diet only, but an intense physical activity was the most effective protocol to obtain a reduction of body fat and maintain muscle mass. Trial registration The study protocol complied with the Declaration of Helsinki for medical studies, it was approved by the bioethical committee of Córdoba University, in the Department of Health at the Regional Government of Andalusia (Act n°284, ref.4156) and retrospectively registered in clinicaltrials.gov (NCT03833791). Registered 2 January 2019.


2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 1259-1259
Author(s):  
Qiaochu Xue ◽  
Xiang Li ◽  
Hao Ma ◽  
Tao Zhou ◽  
Yoriko Heianza ◽  
...  

Abstract Objectives To examine whether objectively measured physical activity (PA) is associated with weight loss and changes in body composition and fat distribution in response to weight-loss diet interventions. Methods This study included 535 overweight or obese participants randomly assigned to 4 weight-loss diets varying in macronutrient intake with physical activity measured objectively with pedometers in the POUNDS Lost trial. The associations of step defined PA or the changes in PA with the changes in obesity measurements including body weight (BW), waist circumference (WC), body fat composition assessed by the dual-energy X-ray absorptiometry (DEXA) scans, body fat distribution assessed by the computed tomography (CT) were examined at the 6 and 24 months. We also examined whether the associations were modified by diet interventions. Results The increase of step-defined PA was significantly predictive of weight loss and decrease in all measurements of body fat composition and distribution in response to diet interventions over 24 months (P &lt; 0.0001 for all). We also observed significant inverse associations of changes in PA with changes in BW (P &lt; 0.0001), WC (P &lt; 0.0001), body fat composition (P &lt; 0.05 for total fat, total lean, total fat mass %, and trunk fat %) and fat distribution (P &lt; 0.05 for total adipose tissue mass (TAT), visceral adipose tissue mass (VAT), deep subcutaneous adipose tissue mass (DSAT)) from baseline to 6 months, when the maximum weight loss was achieved. Dietary fat or protein intake modified the associations between changes in PA and changes in body weight and waist circumference over 24 months; greater reduction in these measures was observed in participants with high-fat or low-protein diets than those in the low-fat or high-protein diets (P interaction &lt; 0.05 for all). Conclusions Our results indicate that objectively measured PA is inversely related to the changes in body weight, body composition, and fat distribution in response to weight-loss diets, and such relation is more evident in people with high-fat or low-protein diets. Funding Sources The study was supported by grants from the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the Fogarty International Center, and Tulane Research Centers of Excellence Awards.


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