Weight Loss Effect of an App-Based Multimodal Lifestyle Intervention in Adults with Obesity—A Randomized Controlled Trial †
by
, and
Kathrin Gemesi
1,*
,
Stefanie Winkler
1,
Florian Schederecker
2,
Hans Hauner
1,3 and
Christina Holzapfel
1,4 1
Institute for Nutritional Medicine, School of Medicine, Technical University of Munich, 80992 Munich, Germany
2
Chair of Epidemiology, Department of Sport and Health Sciences, Technical University of Munich, 80992 Munich, Germany
3
Else Kröner Fresenius Center for Nutritional Medicine, School of Life Sciences, Technical University of Munich, 85354 Freising, Germany
4
Department of Nutritional, Food and Consumer Sciences, Fulda University of Applied Sciences, 36037 Fulda, Germany
*
Author to whom correspondence should be addressed.
†
Presented at the 14th European Nutrition Conference FENS 2023, Belgrade, Serbia, 14–17 November 2023.
Proceedings 2023, 91(1), 68; https://doi.org/10.3390/proceedings2023091068
Published: 22 November 2023
(This article belongs to the Proceedings of The 14th European Nutrition Conference FENS 2023)
Abstract
:Quality-proven Digital Health Applications (DiGAs) or “apps on prescription” in Germany extend obesity treatment options. This 24-week single-center randomized controlled trial aimed to examine the weight-lowering effect of an evidence-based multimodal weight loss intervention program delivered by a DiGA. Methods: Adults with a body mass index (BMI) between 30.0 and 40.0 kg/m2 were randomized. In the first 12 weeks, participants either received the app (ADHOC group) or were asked to maintain their current lifestyle (EXPECT group). In the second 12 weeks, the ADHOC group were invited to continue app use and the EXPECT group started with the app intervention. At three visits (baseline, after 12, and 24 weeks), anthropometric variables were measured and quality of life, app usage, and user acceptance were collected by questionnaires (Euroquol, Technology Acceptance Model 3, System Usability Scale). A total of 168 participants (age: 46.8 ± 11.0 years, BMI: 34.2 ± 2.8 kg/m2, 64.3% women) were included. The total adherence rates were 82.7% after 12 weeks and 67.3% after 24 weeks. After 12 weeks, the ADHOC group showed a mean weight loss of 3.2 ± 3.0% and the EXPECT group a mean weight loss of 0.3 ± 2.6% with a statistically significant difference between the groups (p < 0.001, completers analysis). At the 12-week follow-up, the ADHOC group maintained body weight (weight loss after 24 weeks: 3.1 ± 4.5%, completers analysis), whereas the EXPECT group—starting with the app intervention—lost weight. The investigated multimodal intervention program delivered by a DiGA resulted in a significant and clinically meaningful short-term weight loss with weight maintenance for a further three months.
Author Contributions
Study protocol design, C.H. and H.H.; conducting study visits, K.G., S.W., and C.H.; data management and statistical analysis, K.G.; support of statistical analysis, F.S.; data interpretation, K.G., F.S., H.H. and C.H.; writing, K.G. All authors contributed to the manuscript and approved the submitted version. All authors have read and agreed to the published version of the manuscript.
Funding
The study was funded by the Oviva AG, Potsdam, Germany.
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki, and approved by the Ethical Committee of the School of Medicine and Health at the Technical University of Munich (number: 45/22 S-NP, date: 3 March 32022). The study protocol has been submitted to BfArM (Federal Institute for Drugs and Medical Devices) for reviewing before starting the trial. The study is registered in the German Register of Clinical Studies (Registration number: DRKS00025291).
Informed Consent Statement
Informed consent was obtained from all participants involved in the study.
Data Availability Statement
The data presented in this study are available on request from the corresponding author.
Conflicts of Interest
K.G., S.W. and F.S. declare no conflict of interest. H.H. is a member of the scientific advisory board of Oviva AG (Zurich, Switzerland) and C.H. of 4sigma GmbH (Oberhaching, Germany). H.H. and C.H. received speaker honoraries from Novo Nordisk (Copenhagen, Denmark).
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© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
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MDPI and ACS Style
Gemesi, K.; Winkler, S.; Schederecker, F.; Hauner, H.; Holzapfel, C. Weight Loss Effect of an App-Based Multimodal Lifestyle Intervention in Adults with Obesity—A Randomized Controlled Trial. Proceedings 2023, 91, 68. https://doi.org/10.3390/proceedings2023091068
AMA Style
Gemesi K, Winkler S, Schederecker F, Hauner H, Holzapfel C. Weight Loss Effect of an App-Based Multimodal Lifestyle Intervention in Adults with Obesity—A Randomized Controlled Trial. Proceedings. 2023; 91(1):68. https://doi.org/10.3390/proceedings2023091068
Chicago/Turabian StyleGemesi, Kathrin, Stefanie Winkler, Florian Schederecker, Hans Hauner, and Christina Holzapfel. 2023. "Weight Loss Effect of an App-Based Multimodal Lifestyle Intervention in Adults with Obesity—A Randomized Controlled Trial" Proceedings 91, no. 1: 68. https://doi.org/10.3390/proceedings2023091068
