Effect of Wearable Technology Combined With a Lifestyle Intervention on Long-term Weight Loss: The IDEA Randomized Clinical Trial.

Importance: Effective long-term treatments are needed to address the obesity epidemic. Numerous wearable technologies specific to physical activity and diet are available, but it is unclear if these are effective at improving weight loss. Objective: To test the hypothesis that, compared with a standard behavioral weight loss intervention (standard intervention), a technology-enhanced weight loss intervention (enhanced intervention) would result in greater weight loss. Design, Setting, Participants: Randomized clinical trial conducted at the University of Pittsburgh and enrolling 471 adult participants between October 2010 and October 2012, with data collection completed by December 2014. Interventions: Participants were placed on a low-calorie diet, prescribed increases in physical activity, and had group counseling sessions. At 6 months, the interventions added telephone counseling sessions, text message prompts, and access to study materials on a website. At 6 months, participants randomized to the standard intervention group initiated self-monitoring of diet and physical activity using a website, and those randomized to the enhanced intervention group were provided with a wearable device and accompanying web interface to monitor diet and physical activity. Main Outcomes and Measures: The primary outcome of weight was measured over 24 months at 6-month intervals, and the primary hypothesis tested the change in weight between 2 groups at 24 months. Secondary outcomes included body composition, fitness, physical activity, and dietary intake.
Results: Among the 471 participants randomized (body mass index [BMI], 25 to <40; age range, 18-35 years; 28.9% nonwhite, 77.2% women), 470 (233 in the standard intervention group, 237 in the enhanced intervention group) initiated the interventions as randomized, and 74.5% completed the study. For the enhanced intervention group, mean base line weight was 96.3 kg (95% CI, 94.2-98.5) and 24-month weight 92.8 kg (95% CI, 90.6- 95.0) [corrected]. For the standard intervention group, mean baseline weight was 95.2kg (95%CI,93.0-97.3)and24-month weight was 89.3 kg (95%CI, 87.1-91.5) [corrected]. Weight change at 24 months differed significantly by intervention group (estimated mean weight loss, 3.5 kg [95% CI, 2.6-4.5} in the enhanced intervention group and 5.9 kg [95% CI, 5.0-6.8] in the standard intervention group; difference, 2.4 kg [95% CI, 1.0-3.7]; P = .002). Both groups had significant improvements in body composition, fitness, physical activity, and diet, with no significant difference between groups. Conclusions and Relevance: Among young adults with a BMI between 25 and less than 40, the addition of a wearable technology device to a standard behavioral intervention resulted in less weight loss over 24 months. Devices that monitor and provide feedback on physical activity may not offer an advantage over standard behavioral weight loss approaches. Trial Registration: clinicaltrials.gov Identifier: NCT01131871.

RCT Entities:   Population Interventions Outcomes