Comparing the Efficacy of Digital and In-Person Weight Loss Interventions for Patients with Obesity and Glycemic Disorders: Evidence from a Randomized Non-Inferiority Trial

. 2024 May 16 ; 16 (10) : . [epub] 20240516

Jazyk angličtina Země Švýcarsko Médium electronic

Typ dokumentu časopisecké články, randomizované kontrolované studie, srovnávací studie

Perzistentní odkaz   https://www.medvik.cz/link/pmid38794747

Grantová podpora
IGA_LF_2020_030 Palacký University Olomouc

Digital weight loss interventions present a viable and cost-effective alternative to traditional therapy. However, further evidence is needed to establish the equal effectiveness of both approaches. This randomized controlled non-inferiority trial aimed to compare the effects of an intensive in-person weight loss intervention program with Vitadio digital therapy. One hundred patients with obesity and diagnosed with type 2 diabetes, prediabetes, or insulin resistance were enrolled and randomly assigned to one of the two treatment groups. Over a 6-month period, the control group received five in-person consultations with a physician who specialized in obesity treatment, a dietitian and/or a nutrition nurse, while the intervention group followed the digital program based on a multimodal therapeutic approach. The extent of weight loss was assessed and compared between the groups. Additionally, changes in body composition and metabolic parameters for the digital intervention group were analyzed. The study results demonstrated comparable effectiveness of both treatments for weight reduction. The positive effects of Vitadio were further evidenced by favorable changes in body composition and lipid metabolism and improved glycemic control in the intervention group. These findings suggest that Vitadio is an effective tool for assisting patients with managing obesity and preventing diabetes progression.

Zobrazit více v PubMed

DTA Digital Therapeutics Alliance. DTx Definition—Technical Report. [(accessed on 28 February 2024)]. Available online: https://dtxalliance.org/understanding-dtx/

Huh K.Y., Oh J., Lee S., Yu K.S. Clinical Evaluation of Digital Therapeutics: Present and Future. Healthc. Inform. Res. 2022;28:188–197. doi: 10.4258/HIR.2022.28.3.188. PubMed DOI PMC

Dang A., Arora D., Rane P. Role of digital therapeutics and the changing future of healthcare. J. Fam. Med. Prim. Care. 2020;9:2207. doi: 10.4103/JFMPC.JFMPC_105_20. PubMed DOI PMC

Kim M., Choi H.J. Digital Therapeutics for Obesity and Eating-Related Problems. Endocrinol. Metab. 2021;36:220–228. doi: 10.3803/ENM.2021.107. PubMed DOI PMC

Safaei M., Sundararajan E.A., Driss M., Boulila W., Shapi’i A. A systematic literature review on obesity: Understanding the causes & consequences of obesity and reviewing various machine learning approaches used to predict obesity. Comput. Biol. Med. 2021;136:104754. doi: 10.1016/J.COMPBIOMED.2021.104754. PubMed DOI

Lin X., Li H. Obesity: Epidemiology, Pathophysiology, and Therapeutics. Front. Endocrinol. 2021;12:706978. doi: 10.3389/FENDO.2021.706978. PubMed DOI PMC

De Lorenzo A., Gratteri S., Gualtieri P., Cammarano A., Bertucci P., Di Renzo L. Why primary obesity is a disease? J. Transl. Med. 2019;17:1–13. doi: 10.1186/S12967-019-1919-Y. PubMed DOI PMC

Scully T., Ettela A., LeRoith D., Gallagher E.J. Obesity, Type 2 Diabetes, and Cancer Risk. Front. Oncol. 2020;10:615375. doi: 10.3389/FONC.2020.615375. PubMed DOI PMC

Pati S., Irfan W., Jameel A., Ahmed S., Shahid R.K. Obesity and Cancer: A Current Overview of Epidemiology, Pathogenesis, Outcomes, and Management. Cancers. 2023;15:485. doi: 10.3390/CANCERS15020485. PubMed DOI PMC

Zhang X., Ha S., Lau H.C.H., Yu J. Excess body weight: Novel insights into its roles in obesity comorbidities. Semin. Cancer Biol. 2023;92:16–27. doi: 10.1016/J.SEMCANCER.2023.03.008. PubMed DOI

Aras M., Tchang B.G., Pape J. Obesity and Diabetes. Nurs. Clin. N. Am. 2021;56:527–541. doi: 10.1016/J.CNUR.2021.07.008. PubMed DOI

Landovská P., Karbanová M. Social costs of obesity in the Czech Republic. Eur. J. Health Econ. HEPAC Health Econ. Prev. Care. 2023;24:1321–1341. doi: 10.1007/S10198-022-01545-8. PubMed DOI PMC

Velazquez A., Apovian C.M. Updates on obesity pharmacotherapy. Ann. N. Y. Acad. Sci. 2018;1411:106–119. doi: 10.1111/NYAS.13542. PubMed DOI

Spring B., Duncan J.M., Janke E.A., Kozak A.T., McFadden H.G., Demott A., Pictor A., Epstein L.H., Siddique J., Pellegrini C.A., et al. Integrating Technology Into Standard Weight Loss Treatment: A Randomized Controlled Trial. JAMA Intern. Med. 2013;173:105–111. doi: 10.1001/JAMAINTERNMED.2013.1221. PubMed DOI PMC

Eghbali F., Jahanshahi F., Garakani K., Ghasemi S., Talebi A., Oshidari B., Mosavari H., Pazouki A. Reasons for Preoperative Patient Attrition among Bariatric Surgery Candidates: Patients’ Point of View. Obes. Surg. 2023;33:492. doi: 10.1007/S11695-022-06373-6. PubMed DOI PMC

Ponzo V., Scumaci E., Goitre I., Beccuti G., Benso A., Belcastro S., Crespi C., De Michieli F., Pellegrini M., Scuntero P., et al. Predictors of attrition from a weight loss program. A study of adult patients with obesity in a community setting. Eat. Weight. Disord. 2021;26:1729. doi: 10.1007/S40519-020-00990-9. PubMed DOI PMC

Patel N.A., Butte A.J. Characteristics and challenges of the clinical pipeline of digital therapeutics. NPJ Digit. Med. 2020;3:1–5. doi: 10.1038/s41746-020-00370-8. PubMed DOI PMC

Moravcová K., Karbanová M., Bretschneider M.P., Sovová M., Ožana J., Sovová E. Comparing Digital Therapeutic Intervention with an Intensive Obesity Management Program: Randomized Controlled Trial. Nutrients. 2022;14:2005. doi: 10.3390/NU14102005. PubMed DOI PMC

Williamson D.A., Bray G.A., Ryan D.H. Is 5% weight loss a satisfactory criterion to define clinically significant weight loss? Obesity. 2015;23:2319–2320. doi: 10.1002/OBY.21358. PubMed DOI

Carpenter J.R., Roger J.H., Kenward M.G. Analysis of longitudinal trials with protocol deviation: A framework for relevant, accessible assumptions, and inference via multiple imputation. J. Biopharm. Stat. 2013;23:1352–1371. doi: 10.1080/10543406.2013.834911. PubMed DOI

White I.R., Royston P., Wood A.M. Multiple imputation using chained equations: Issues and guidance for practice. Stat. Med. 2011;30:377–399. doi: 10.1002/SIM.4067. PubMed DOI

Kupila S.K., Joki A., Suojanen L.U., Pietiläinen K.H. The Effectiveness of eHealth Interventions for Weight Loss and Weight Loss Maintenance in Adults with Overweight or Obesity: A Systematic Review of Systematic Reviews. Curr. Obes. Rep. 2023;12:371. doi: 10.1007/S13679-023-00515-2. PubMed DOI PMC

Blackburn M., Stathi A., Keogh E., Eccleston C. Raising the topic of weight in general practice: Perspectives of GPs and primary care nurses. BMJ Open. 2015;5:e008546. doi: 10.1136/BMJOPEN-2015-008546. PubMed DOI PMC

Kim T.N. Barriers to Obesity Management: Patient and Physician Factors. J. Obes. Metab. Syndr. 2020;29:244. doi: 10.7570/JOMES20124. PubMed DOI PMC

Haase C.L., Lopes S., Olsen A.H., Satylganova A., Schnecke V., McEwan P. Weight loss and risk reduction of obesity-related outcomes in 0.5 million people: Evidence from a UK primary care database. Int. J. Obes. 2021;45:1249–1258. doi: 10.1038/s41366-021-00788-4. PubMed DOI PMC

Wharton S., Lau D.C., Vallis M., Sharma A.M., Biertho L., Campbell-Scherer D., Adamo K., Alberga A., Bell R., Boulé N., et al. Obesity in adults: A clinical practice guideline. Can. Med. Assoc. J. 2020;192:E875–E891. doi: 10.1503/CMAJ.191707/TAB-RELATED-CONTENT. PubMed DOI PMC

Cava E., Yeat N.C., Mittendorfer B. Preserving Healthy Muscle during Weight Loss. Adv. Nutr. 2017;8:511–519. doi: 10.3945/AN.116.014506. PubMed DOI PMC

Ashwell M., Gibson S. Waist-to-height ratio as an indicator of ’early health risk’: Simpler and more predictive than using a ’matrix’ based on BMI and waist circumference. BMJ Open. 2016;6:e010159. doi: 10.1136/BMJOPEN-2015-010159. PubMed DOI PMC

Dong Y., Zhou J., Zhu Y., Luo L., He T., Hu H., Liu H., Zhang Y., Luo D., Xu S., et al. Abdominal obesity and colorectal cancer risk: Systematic review and meta-analysis of prospective studies. Biosci. Rep. 2017;37:20170945. doi: 10.1042/BSR20170945/57826. PubMed DOI PMC

Chu J.J., Mehrzad R. Inflammation and Obesity: A New and Novel Approach to Manage Obesity and Its Consequences. Academic Press; Cambridge, MA, USA: 2022. Pathophysiology of obesity; pp. 31–47. DOI

Paley C.A., Johnson M.I. Abdominal obesity and metabolic syndrome: Exercise as medicine? BMC Sport. Sci. Med. Rehabil. 2018;10:1–8. doi: 10.1186/S13102-018-0097-1/PEER-REVIEW. PubMed DOI PMC

Willoughby D., Hewlings S., Kalman D. Body Composition Changes in Weight Loss: Strategies and Supplementation for Maintaining Lean Body Mass, a Brief Review. Nutrients. 2018;10:1876. doi: 10.3390/NU10121876. PubMed DOI PMC

Haines M.S., Dichtel L.E., Santoso K., Torriani M., Miller K.K., Bredella M.A. Association between muscle mass and insulin sensitivity independent of detrimental adipose depots in young adults with overweight/obesity. Int. J. Obes. 2020;44:1851. doi: 10.1038/S41366-020-0590-Y. PubMed DOI PMC

McCarthy D., Berg A. Weight Loss Strategies and the Risk of Skeletal Muscle Mass Loss. Nutrients. 2021;13:2473. doi: 10.3390/NU13072473. PubMed DOI PMC

Laufs U., Parhofer K.G., Ginsberg H.N., Hegele R.A. Clinical review on triglycerides. Eur. Heart J. 2020;41:99–109. doi: 10.1093/EURHEARTJ/EHZ785. PubMed DOI PMC

Baratta F., Cocomello N., Coronati M., Ferro D., Pastori D., Angelico F., Ben M.D. Cholesterol Remnants, Triglyceride-Rich Lipoproteins and Cardiovascular Risk. Int. J. Mol. Sci. 2023;24:4268. doi: 10.3390/IJMS24054268. PubMed DOI PMC

Masson W., Lobo M., Siniawski D., Molinero G., Huerín M., Nogueira J.P. Impact of Lipid-Lowering Therapy on Mortality According to the Baseline Non-HDL Cholesterol Level: A Meta-Analysis. High Blood Press. Cardiovasc. Prev. 2019;26:263–272. doi: 10.1007/S40292-019-00330-8/FIGURES/6. PubMed DOI

Su X., Kong Y., Peng D. Evidence for changing lipid management strategy to focus on non-high density lipoprotein cholesterol. Lipids Health Dis. 2019;18:1–7. doi: 10.1186/S12944-019-1080-X/FIGURES/1. PubMed DOI PMC

Najít záznam

Citační ukazatele

Nahrávání dat ...

Možnosti archivace

Nahrávání dat ...