JMIR Publications

ABSTRACT

Background:

Obesity is a chronic, relapsing disease resulting in global morbidity and mortality. Treatment continues to present significant challenges for healthcare providers. For adults, multicomponent lifestyle interventions—comprising diet, physical activity, and behavioral change strategies—are the mainstay of treatment for at least 6 to 12 months. However, patient adherence to lifestyle changes remains modest, and these interventions often require multiple in-person sessions, which can be time-consuming, costly, and challenging for both patients and healthcare providers. Given the evolving landscape of digital health, digital therapeutics could play a key role in improving and scaling obesity management interventions.

Objective:

this prospective, multicentre, randomized, double-arm, single-blind, placebo-controlled trial evaluated the 6-month efficacy of an innovative, multi-component, digital intervention for weight loss by increasing patients’ adherence to treatment in people living with obesity.

Methods:

two clinical centres enrolled a total of 246 participants, who were randomized to the Digital Therapeutics for Obesity (DTxO) or the Placebo App group.

Results:

Overall, 207 (84.1%) completed the 6-month visit; both arms achieved a statistically significant absolute and percent loss in body weight at the 6-month follow-up without significant between groups differences (p =0.415 and p=0.340, respectively). Univariable regression analyses showed a net impact of adherence to the app use on the 6-month absolute [β=-0.06 (standard error (SE)=0.02), p=0.005] and percent changes in body weight [β=-0.05 (SE=0.01), p=0.009]. At multivariable analysis, adjusted for clinical site, the estimated 6-month mean absolute change in weight was -7.02 kg [95% confidence interval (CI): -9.45; -4.59] in the DtxO-adherent group and -3.50 kg [95%CI: -7.01; 0.01] in the Placebo App-adherent group (p=0.019). The estimated 6-month mean %change in weight was -6.31% [95%CI: -8.86; -3.76] in the DTxO-adherent group and -2.78% [95%CI: -6.48; 0.92] in the Placebo App-adherent group (p=0.025).

Conclusions:

This trial demonstrated the effectiveness of DTxO compared to a Placebo App on 6-month weight loss in people living with obesity, adherent to DTxO of at least 16 min/day to a dietary, physical activity, and mindfulness digital health multidimensional intervention. Further studies are needed to explore the additional benefits of DTxO associated with new drugs or bariatric surgery in obesity management. Clinical Trial: clinicaltrials.gov, identifier, NCT05394779.