Institute of Biomedical Research of Salamanca (IBSAL), Primary Care Research Unit of Salamanca (APISAL), Health Service of Castilla y León (SACyL), Salamanca, Spain.
Institute for Health Research Aragón (IISA), Department of Internal Medicine, Psychiatry and Dermatology, University of Zaragoza, Zaragoza, Spain.
JMIR Mhealth Uhealth. 2020 Nov 26;8(11):e21771. doi: 10.2196/21771.
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.
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.
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.
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, 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 (95% CI -0.80 to -0.13), whereas the obese group only experienced a change in BMI of -0.53 kg/m (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 (95% CI -0.83 to -0.19).
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 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.
Clinicaltrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1097/MD.0000000000009633.
移动健康（mHealth）目前是有助于人们采用更健康生活方式以改善健康指标的支持元素之一。mHealth 干预措施已被广泛报道可实现比其他方法更大的体重减轻，但它们对身体成分的影响仍不清楚。
本研究旨在评估一款移动应用程序和一款智能手环在帮助超重或肥胖的西班牙久坐成年人减肥和改变身体成分方面的短期（3 个月）效果。
进行了一项随机对照、多中心临床试验，共有来自初级保健中心的 440 名受试者参与，其中干预组（IG；使用智能手机应用程序和智能手环进行咨询）有 231 名受试者，对照组（CG；仅进行咨询）有 209 名。两组均接受健康饮食和身体活动的咨询。在 3 个月的干预期间，IG 接受了使用涉及自我监测和个性化反馈的智能手机应用程序以及记录日常身体活动的智能手环（小米手环 2，小米）的培训。使用 InBody 230 生物阻抗设备（InBody Co.，Ltd）测量身体成分，使用国际身体活动问卷测量身体活动。
与标准咨询相比，mHealth 干预在 3 个月时产生了更大的体重减轻（-1.97kg，95%置信区间-2.39 至-1.54）。与 CG 相比，IG 在 3 个月时的体重减轻了 0.84kg。IG 显示体脂肪量（BFM）减少（-1.84kg，95%置信区间-2.48 至-1.20），体脂肪百分比（PBF）减少（-1.22%，95%置信区间-1.82%至 0.62%）和 BMI 减少（-0.77kg/m，95%置信区间-0.96 至-0.57）。在男性中未观察到这些参数中的任何一个有显著变化；在女性中，与 CG 相比，IG 的 BMI 显著下降。当根据基线 BMI 对受试者进行分组时，超重组的 BFM 变化为-1.18kg（95%置信区间-2.30 至-0.06）和 BMI 变化为-0.47kg/m（95%置信区间-0.80 至-0.13），而肥胖组仅 BMI 变化为-0.53kg/m（95%置信区间-0.86 至-0.19）。当根据身体活动对数据进行分析时，中高强度身体活动组的 BFM 变化为-1.03kg（95%置信区间-1.74 至-0.33），PBF 变化为-0.76%（95%置信区间-1.32%至-0.20%）和 BMI 变化为-0.5kg/m（95%置信区间-0.83 至-0.19）。
这项多中心、随机对照临床试验研究的结果表明，与单独标准咨询相比，在 BMI 小于 30kg/m2 且中高强度身体活动水平的女性受试者中，添加自我报告的应用程序和智能手环可获得体重减轻和 BFM 和 PBF 减少的有益效果。然而，需要进一步的研究来确保这种情况使更多人受益于这种干预，并研究这种干预的修改以实现全面效果。
Clinicaltrials.gov NCT03175614；https://clinicaltrials.gov/ct2/show/NCT03175614。
国际注册报告标识符（IRRID）：RR2-10.1097/MD.0000000000009633。
