Comparing Digital Therapeutic Intervention with an Intensive Obesity Management Program: Randomized Controlled Trial.
Katarína MoravcováMartina KarbanováMaxi Pia BretschneiderMarkéta SovováJaromír OžanaEliška SovováPublished in: Nutrients (2022)
In this study, we evaluated whether the digital program Vitadio achieves comparable results to those of an intensive in-person lifestyle intervention in obesity management. This is a 12-month prospective, randomized controlled trial. Obese patients with insulin resistance, prediabetes or type 2 diabetes were included. The intervention group (IG) used Vitadio. The control group (CG) received a series of in-person consultations. Body weight and various metabolic parameters were observed and analyzed with ANOVA. The trial is ongoing and the presented findings are preliminary. Among 100 participants (29% men; mean age, 43 years; mean BMI, 40.1 kg/m 2 ), 78 completed 3-month follow-up, and 51 have completed the 6-month follow-up so far. Participants significantly ( p < 0.01) reduced body weight at 3 months (IG: -5.9 ± 5.0%; CG: -4.2 ± 5.0%) and 6 months (IG: -6.6±6.1%; CG: -7.1 ± 7.1%), and the difference between groups was not significant. The IG achieved favorable change in body composition; significant improvement in TAG (-0.6 ± 0.9 mmol/l, p < 0.01), HDL (0.1 ± 0.1%, p < 0.05), HbA1c (-0.2 ± 0.5%, p < 0.05) and FG (-0.5 ± 1.5 mmol/l, p < 0.05); and a superior ( p = 0.02) HOMA-IR reduction (-2.5 ± 5.2, p < 0.01). The digital intervention achieved comparable results to those of the intensive obesity management program. The results suggest that Vitadio is an effective tool for supporting patients in obesity management and diabetes prevention.
Keyphrases
- randomized controlled trial
- insulin resistance
- type diabetes
- body weight
- metabolic syndrome
- weight loss
- body composition
- study protocol
- high fat diet induced
- adipose tissue
- weight gain
- glycemic control
- high fat diet
- skeletal muscle
- polycystic ovary syndrome
- quality improvement
- bariatric surgery
- cardiovascular disease
- clinical trial
- body mass index
- end stage renal disease
- ejection fraction
- systematic review
- primary care
- newly diagnosed
- physical activity
- bone mineral density
- phase ii
- phase iii
- postmenopausal women
- open label
- meta analyses