Primary Care Research Unit of Salamanca (APISAL), Institute of Biomedical Research of Salamanca, Health Service of Castilla y León, Salamanca, Spain.
Department of Nursing and Physiotherapy, University of Salamanca, Salamanca, Spain.
J Med Internet Res. 2022 Feb 1;24(2):e30416. doi: 10.2196/30416.
Multicomponent mobile health approaches can improve lifestyle intervention results, although little is known about their long-term effectiveness.
This study aims to evaluate the long-term effectiveness (12 months) of a multicomponent mobile health intervention-combining a smartphone app, an activity tracker wristband, and brief counseling, compared with a brief counseling group only-on weight loss and improving body composition, physical activity, and caloric intake in Spanish sedentary adults with overweight or obesity.
We conducted a randomized controlled, multicenter clinical trial (Evident 3). A total of 650 participants were recruited from 5 primary care centers, with 318 participants in the intervention group (IG) and 332 in the control group (CG). All participants were briefly counseled about a healthy diet and physical activity at the baseline visit. For the 3-month intervention period, the IG received training to use the app to promote healthy lifestyles and the smart band (Mi Band 2, Xiaomi). All measurements were performed at baseline and at 3 and 12 months. Physical activity was measured using the International Physical Activity Questionnaire-Short Form. Nutritional habits were assessed using the Food Frequency Questionnaire and Adherence to Mediterranean diet questionnaire.
Of the 650 participants included, 563 (86.6%) completed the 3-month visit and 443 (68.2%) completed the 12-month visit. After 12 months, the IG showed net differences in weight (-0.26, 95% CI -1.21 to 0.70 kg; P=.02), BMI (-0.06, 95% CI -0.41 to 0.28 points; P=.01), waist-height ratio (-0.25, 95% CI -0.94 to 0.44; P=.03), body adiposity index (-0.33, 95% CI -0.77 to 0.11; P=.03), waist circumference (-0.48, 95% CI -1.62 to 0.66 cm, P=.04) and hip circumference (-0.69, 95% CI -1.62 to 0.25 cm; P=.03). Both groups lowered daily caloric intake and increased adherence to the Mediterranean diet, with no differences between the groups. The IG increased light physical activity time (32.6, 95% CI -30.3 to 95.04 min/week; P=.02) compared with the CG. Analyses by subgroup showed changes in body composition variables in women, people aged >50 years, and married people.
The low-intensity intervention of the Evident 3 study showed, in the IG, benefits in weight loss, some body composition variables, and time spent in light physical activity compared with the CG at 3 months, but once the devices were collected, the downward trend was not maintained at the 12-month follow-up. No differences in nutritional outcomes were observed between the groups.
ClinicalTrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1097/MD.0000000000009633.
多组分移动健康方法可以改善生活方式干预的效果，尽管人们对其长期效果知之甚少。
本研究旨在评估多组分移动健康干预（结合智能手机应用程序、活动跟踪腕带和简短咨询）与仅进行简短咨询组相比，在西班牙超重或肥胖的久坐成年人中，在减肥和改善身体成分、身体活动和热量摄入方面的 12 个月的长期效果。
我们进行了一项随机对照、多中心临床试验（Evident 3）。从 5 家初级保健中心招募了 650 名参与者，其中 318 名参与者被分配到干预组（IG），332 名参与者被分配到对照组（CG）。所有参与者在基线访视时都接受了关于健康饮食和身体活动的简短咨询。在 3 个月的干预期间，IG 接受了使用应用程序促进健康生活方式和智能手环（小米手环 2）的培训。所有测量均在基线、3 个月和 12 个月时进行。身体活动使用国际体力活动问卷-短表进行测量。营养习惯使用食物频率问卷和地中海饮食问卷进行评估。
在纳入的 650 名参与者中，563 名（86.6%）完成了 3 个月的访视，443 名（68.2%）完成了 12 个月的访视。12 个月后，IG 在体重（-0.26，95%CI-1.21 至 0.70 千克；P=.02）、BMI（-0.06，95%CI-0.41 至 0.28 点；P=.01）、腰高比（-0.25，95%CI-0.94 至 0.44；P=.03）、身体脂肪指数（-0.33，95%CI-0.77 至 0.11；P=.03）、腰围（-0.48，95%CI-1.62 至 0.66 厘米，P=.04）和臀围（-0.69，95%CI-1.62 至 0.25 厘米；P=.03）方面均表现出净差异。两组均降低了每日热量摄入并增加了对地中海饮食的依从性，但两组之间没有差异。与 CG 相比，IG 的轻体力活动时间增加了（32.6，95%CI-30.3 至 95.04 分钟/周；P=.02）。亚组分析显示，女性、年龄>50 岁和已婚人群的身体成分变量发生了变化。
Evident 3 研究的低强度干预在 IG 中显示，与 CG 相比，在 3 个月时体重减轻、某些身体成分变量和轻体力活动时间增加，但一旦收集了设备，12 个月随访时就没有维持下降趋势。两组之间没有观察到营养结果的差异。
ClinicalTrials.gov NCT03175614；https://clinicaltrials.gov/ct2/show/NCT03175614。
国际注册报告标识符（IRRID）：RR2-10.1097/MD.0000000000009633。
