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: 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

Relationship between physical activity and plasma fibrinogen concentrations in adults without chronic diseases.

To analyze the relationship between regular physical activity, as assessed by accelerometer and 7-day physical activity recall (PAR), and plasma fibrinogen concentrations.A cross-sectional study in a previously established cohort of healthy subjects was performed. This study analyzed 1284 subjects who were included in the EVIDENT study (mean age 55.0±13.6 years; 60.90% women). Fibrinogen concentrations were measured in blood plasma. Physical activity was assessed with a 7-day PAR (metabolic equivalents (METs)/hour/week) and GT3X ActiGraph accelerometer (counts/minute) for 7 days.Physical exercise, which was evaluated with both an accelerometer (Median: 237.28 counts/minute) and 7-day PAR (Median: 8 METs/hour/week). Physical activity was negatively correlated with plasma fibrinogen concentrations, which was evaluated by counts/min (r = -0.100; p<0.001) and METs/hour/week (r = -0.162; p<0.001). In a multiple linear regression analysis, fibrinogen concentrations of the subjects who performed more physical activity (third tertile of count/minute and METs/hour/week) respect to subjects who performed less (first tertile), maintained statistical significance after adjustments for age and others confounders (β = -0.03; p = 0.046 and β = -0.06; p<0.001, respectively).Physical activity, as assessed by accelerometer and 7-day PAR, was negatively associated with plasma fibrinogen concentrations. This relation is maintained in subjects who performed more exercise even after adjusting for age and other confounders

Physical exercise assessment by accelerometer and 7-day PAR.

<p>Values are medians and interquartile range(IQR) for asymmetrically distributed continuous data and number and proportions for categorical data.</p><p>METs: metabolic equivalent. Active were considered as those doing at least 30 minutes of moderate activity, five days a week, or at least 20 minutes of hard activity, 3 days a week.</p

Baseline characteristics of participants in EVIDENT study.

<p>Values are means (standard deviations) for continuous data. Median (interquartile range) for asymmetrically distributed continuous data and number and proportion for categorical data.</p><p>Body adiposity index  =  (hip circumference in centimeters)/(height in meters)^1.5 − 18); HDL: High Density Lipoprotein; LDL: low-density lipoprotein; hs-CRP: high-sensitivity C-Reactive Protein.</p

Multiple regression with plasma fibrinogen concentrations as dependent variable and physical activity as independent variable.

<p>Dependent Variable: Ln_Fibrinogen</p><p>Independent Variables: Tertiles of Counts/minute. Tertiles of METS/hours/week.</p><p>Adjusted variables: Sex (1: male; 0: female); lnAge; Waist circumference. (cm); Alcohol (g/week); Total cholesterol. (mg/dL); Lipid lowering drugs (1:yes; 0:no); Mean blood pressure (mmHg)</p

Bivariate correlations of physical exercise (Counts/minute and METS/hour/week) with biological and anthropometric parameters.

<p>Counts/minute by accelerometer; METS/hour/week by 7-Par/day; hs-CRP: high-sensitivity C-reactive protein; HDL: high-density lipoprotein; LDL: low-density lipoprotein; Body adiposity index =  ((hip circumference)/((height)^1.5) -18)).</p><p>P-values by Spearman correlation. * p<0.05 ** p<0.01.</p