JMIR Publications

ABSTRACT

Background:

Multi-component mHealth approaches could improve lifestyles interventions results, although little is known about their long-term effectiveness.

Objective:

The study aimed to evaluate the long-term effectiveness (12 months) of a multi-component mHealth intervention, combining a smartphone app and a smart band, compared to standard counselling group only, on weight loss and improving body composition, physical activity and caloric intake in Spanish sedentary adults with overweight and obesity.

Methods:

Evident 3 study is a randomized controlled multicenter clinical trial. A total of 650 subjects were recruited from five primary care centers, with 318 subjects in the intervention (app + smart band + counselling) group (IG) and 332 in the control (counselling) group (CG). All participants were counselled about healthy diet and physical activity at 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 carried out at baseline, 3 and 12 months. Physical activity was measured using the International Physical Activity Questionnaire. Nutritional habits were assessed by the Food Frequency Questionnaire and Adherence to Mediterranean diet questionnaire.

Results:

Of the total of 650 participants included, 563 (86.6%) completed the 3-month visit and 443 (68.2%) the 12-month visit. After 12 months, IG significantly achieved changes on weight (-0.26 kg (95%CI -1.21, 0.70)), Body mass index (-0.06 points (95%CI -0.41, 0.28), Waist-height ratio (-0.25 (95%CI -0.94, 0.44)) and Body Adiposity Index (-0.33 (95%CI -0.77, 0.11)) compared with CG. Also, IG showed changes in Waist circumference (-0.48 cm (95%CI -1.62, 0.66)) and Hip circumference (-1.02 cm (95%CI 0.76, 0.34), but no significant differences between groups was observed. Both groups lowered daily caloric intake and increased adherence to Mediterranean diet, with no differences between groups. Moreover, IG significantly increased light physical activity time (32.6 min/week (95%CI -30.3, 95.04)) compared with CG.

Conclusions:

The use of a smartphone application combined with a smart band during 3 months and brief counselling showed in IG benefits on weight loss, some body composition variables and time spent in light physical activity compared with CG at 12-month follow-up. No differences between groups were found in nutritional outcomes. Analyses by subgroups showed greater changes in body composition variables in women, in people over 50 years and married people. Clinical Trial: ClinicalTrials.gov with identifier NCT03175614