Long-term Effectiveness of a Smartphone App Combined With a Smart Band on Weight Loss, Physical Activity, and Caloric Intake in a Population With Overweight and Obesity (Evident 3 Study): Randomized Controlled Trial

Abstract

Background Multicomponent mobile health approaches can improve lifestyle intervention results, although little is known about their long-term effectiveness. Objective 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. Methods 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. Results 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. Conclusions 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. Trial Registration ClinicalTrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614 International Registered Report Identifier (IRRID) RR2-10.1097/MD.0000000000009633

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“…Finally, our findings did not suggest a significant reduction in total calorie intake per day, potentially because of the small sample size. However, similar findings were reported in a large RCT that included patients with existing medical conditions [ 43 ]. The use of a smartphone app together with a smart activity band resulted in greater weight loss 12 months into the program, where both the intervention and control groups were found to have decreased their calorie intake comparably.…”

Short-Term Pilot Study to Evaluate the Impact of Salbi Educa Nutrition App in Macronutrients Intake and Adherence to the Mediterranean Diet: Randomized Controlled Trial

“…SAlBi educa results agree well with the EVIDENT II nutrition app [ 24 ], which increased the intake percentage of carbohydrates (1.1%) and decreased the intake percentage of total fats (1.0%) in the general population. Additionally, the EVIDENT 3 app also enhanced the carbohydrate intake (plus 3.8 g/day) and decreased the total fat intake (minus 4.7 g/day) in an overweight and obese population, although the app’s effect was not significant [ 51 ]. In the same sense, the Lost it!…”

Changes in lifestyles, cognitive impairment, quality of life and activity day living after combined use of smartphone and smartband technology: a randomized clinical trial (EVIDENT-Age study)

“…Although physical activity of moderate or vigorous intensity increased more in the application + counselling group than in the counselling-only group, the results of the EVIDENT 2 study, conducted in the general population, found no differences when comparing the increase between the two groups [ 28 ]. Likewise, although with some change in body composition variables, the EVIDENT 3 study, conducted in an overweight or obese population, did not show relevant changes in the amount and intensity of physical activity or in nutritional habits in the group that used the app and the smartband compared to the control group [ 29 ]. Only a population of older people with type 2 diabetes mellitus obtained beneficial results in terms of increased physical activity and better adaptation to the MD [ 11 , 30 ].…”