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Randomized Controlled Trial
. 2022 Sep;16(5):1150-1158.
doi: 10.1177/19322968211000815. Epub 2021 Mar 19.

Randomized Trial for Weight Loss Using a Digital Therapeutic Application

Tryggvi Thorgeirsson  1   2 , Johanna E Torfadottir  3 , Erlendur Egilsson  4 , Saemundur Oddsson  1 , Thrudur Gunnarsdottir  1 , Thor Aspelund  3 , Anna S Olafsdottir  5 , Unnur A Valdimarsdottir  3   6   7 , Ichiro Kawachi  8 , Hans-Olov Adami  6   7   9 , Ragnar G Bjarnason  2
Affiliations
Randomized Controlled Trial

Randomized Trial for Weight Loss Using a Digital Therapeutic Application

Tryggvi Thorgeirsson et al. J Diabetes Sci Technol. 2022 Sep.

Abstract

Background: Smartphones present a near-ubiquitous channel through which structured lifestyle change can reduce risk or progression of the most common noncommunicable diseases. We explored whether a digital structured lifestyle program enhances weight loss.

Methods: We randomized overweight and obese participants attending a four-month lifestyle change program to either standard weekly coaching sessions (controls), or standard treatment supplemented with a digital therapeutic mobile application (intervention). Changes in body mass index after four months were the main outcome measure. Odds ratios of achieving 5% weight loss were estimated with unconditional logistic regression.

Results: Of 234 eligible persons, 146 (62%) agreed to participate, were block-randomized, showed up for the baseline measures, and constituted the intention-to-treat (ITT) sample (n = 95 intervention group, n = 51 control group). In the intervention group, 70 (74%) downloaded the mobile application and completed the program (intervention per-protocol). Significant weight loss and BMI reduction were observed for both the intention-to-treat intervention group (P < 0.05, P = 0.01) and the per-protocol intervention group (P < 0.0001, P < 0.0001). For the intervention per-protocol group, the odds ratio of achieving 5% weight loss, compared to not treated per-protocol, was 3.3 (95% CI 1.3-8.2), adjusting for age and weight at baseline.Attendance to weekly coaching sessions decreased by 18% during the program in the control group while it increased by 3% amongst the per-protocol group (P = 0.004).

Conclusions: These preliminary findings support the benefit of a digital therapeutic to enhance weight reduction and attendance in a structured lifestyle change program. Larger trials of longer duration are needed to confirm these findings.

Keywords: digital therapeutic; intervention study; mobile application; obesity; prediabetes; weight loss.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Tryggvi Thorgeirsson is a founder and co-owner of SKH, Saemundur Oddsson is a founder and co-owner of SKH, Unnur Anna Valdimarsdóttir has no conflicts of interest, Jóhanna Eyrún Torfadóttir has no conflicts of interest, Anna Sigríður Ólafsdóttir has no conflicts of interest, Ragnar Grímur Bjarnason has no conflicts of interest, Hans-Olov Adami has no conflicts of interest, Ichiro Kawachi has no conflicts of interest, Thrudur Gunnarsdottir is a current employee of SKH, Erlendur Egilsson is a prior employee at a related company and a minority shareholder in SKH.

Figures

Figure 1.
Figure 1.
Screenshots from the mobile digital therapeutic, and characters that were developed to target impulsive, fast-thinking.
Figure 2.
Figure 2.
Appetite awareness training exercise from the app.
Figure 3.
Figure 3.
CONSORT flow diagram of participant recruitment and retention.
See this image and copyright information in PMC

References

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