Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Jun 25, 2020
Date Accepted: Oct 28, 2020
Effectiveness of an mHealth intervention combining a smartphone app and smartband in body composition of overweight and obese population: Randomized Controlled Trial (Evident 3 study)
ABSTRACT
Background:
mHealth is currently among the supporting elements that may contribute to improving health markers by changing people’s lifestyles to healthier ones. These interventions have been widely reported to achieve greater weight loss than other approaches, but their effect on body composition remains unclear.
Objective:
This study aims to assess the short-term (3 months) effectiveness of a mobile app and a smartband for losing weight and changing body composition in sedentary Spanish adults with overweight and obesity.
Methods:
A randomized, controlled, multicenter clinical trial was conducted involving the participation of 440 subjects from primary care centers, with 231 in the intervention (counselling + app + smartband) group (IG) and 209 in the control (counselling) group (CG). Both groups were counselled about healthy diet and physical activity. For the 3-month intervention period, the IG was also trained to use a smartphone app that involved self-monitoring and tailored feedback and a smartband. Body composition was measured by Inbody 320 bioimpedance device, and physical activity was measured using IPAQ questionnaire.
Results:
IG showed a slight decrease in body composition variables, being greater in Body Fat Mass (BFM) losing -1.84kg (95% CI: -2.48, -1.20), -1,22% (95% CI: -1.82-0.62) in Percentage of Body Fat (PBF) and -0.77 kg/m2 (95% CI: -0.96-0.57) in Body Mass Index (BMI). There were no significant changes observed in any of these parameters in men, while BMI had a significant decrease compared with CG in women. Grouping by BMI at baseline, the overweight group reduced BFM by -1.18 kg (95% CI: -2.30, -0.06) and BMI by -0.47 kg/m2 (95% CI: -0.80, -0.13), whereas the obesity type I group only decreased BMI by -0.53 kg/m2 (95% CI: -0.86, -0.19). Analyzing the data according to physical activity, the MVPA group decreased BFM (95% CI: -1.03 kg (95% CI: -1.74, -0.33)), PBF (-0.76% (95% CI: -1.32, -0.20)) and BMI (-0.5 Kg/m2 (95% CI: -0.83, -0.19)) significantly.
Conclusions:
The results from this multicenter randomized clinical trial study show that compared to a standard counselling alone, the use of a self-reported app and a smartband, obtained beneficial results in losing weight in women and a reduction of body fat mass and its percentage in subjects with BMI<30 and moderate-vigorous physical activity. Nevertheless, further studies are needed to ensure that this profile benefits more than others from this intervention and, also, to investigate modifications of this intervention to achieve a global effect. Clinical Trial: Clinicaltrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614
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