A randomized clinical trial evaluating eHealth in bariatric surgery

Abstract

Background: Supporting patients before, and long after, their bariatric treatment contributes a lot to successful outcome. eHealth interventions have a hypothetical benefit in addition to standard care. This could lead to increased weight loss, reduction of obesity-related diseases, patient adherence, and quality of life. This randomized controlled trial aims to evaluate the value of an eHealth platform and self-monitoring devices as additions to standard bariatric care.

Materials and methods: Two-hundred-and-five patients who underwent primary bariatric surgery were randomized (2:1:1) to receive standard care (control group), additional access to an educational patient eHealth platform (online group), or additional access to eHealth platform as well as self-monitoring devices (device group). The platform consisted of an interactive educational environment with informational videos, dietary advice, news, and more. The self-monitoring devices used were a weight scale, blood pressure monitor, pulse oximeter, and activity bracelet. The primary endpoint was weight loss and secondary outcomes included reduction of obesity-related diseases, quality of life, and eHealth use.

Results: Postoperative weight loss, reduction of obesity-related diseases, frequency of consultations, and quality of life were similar between groups. Participation to the eHealth platform was high (online group 90%, device group 98%). Most frequently accessed contents were informational messages, videos, and the treatment preparation modules. The percentage of active users of the self-monitoring devices dropped from 62% in the first postoperative month to 19% after 2 years. Thirteen patients in the device group withdrew due to unwillingness to use self-monitoring devices.

Conclusion: Participation to the eHealth intervention in addition to the standard post-bariatric guidance program was high, however, had no significant impact on clinical outcomes such as weight loss, reduction of obesity-related diseases, and quality of life. Trial registration ClinicalTrials.gov (identifier number NL56992.100.16) https://clinicaltrials.gov/ct2/show/NCT03394638.

Keywords: Bariatric surgery; Obesity; Telemonitoring; eHealth.