Tryggvi Thorgeirsson1,2, Johanna E Torfadottir3, Erlendur Egilsson4, Saemundur Oddsson1, Thrudur Gunnarsdottir1, Thor Aspelund3, Anna S Olafsdottir5, Unnur A Valdimarsdottir3,6,7, Ichiro Kawachi8, Hans-Olov Adami6,7,9, Ragnar G Bjarnason2. 1. Sidekick Health Digital Therapeutics, Kópavogur, Iceland. 2. Faculty of Medicine, University of Iceland and Children's Medical Centre, Landspitali University Hospital, Reykjavik, Iceland. 3. Center of Public Health Sciences, Faculty of Medicine, School of Health Sciences, University of Iceland, Reykjavik, Iceland. 4. Department of Psychology, University of Iceland, Reykjavik, Iceland. 5. Faculty of Health Promotion, Sport and Leisure Studies, School of Education, University of Iceland, Reykjavik, Iceland. 6. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. 7. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA. 8. Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA. 9. Clinical Effectiveness Group, Institute of Health and Society, University of Oslo, Oslo, Norway.
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.
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.
Entities:
Keywords:
digital therapeutic; intervention study; mobile application; obesity; prediabetes; weight loss
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