Supplementary file 1_A randomized parallel-designed study evaluating the effect of an app-based nutritional concept for weight reduction and further cardiovascular risk factors: Insights from the PreVA study.doc

Methods

The PreVa study is a single-center, randomized, four-arm parallel intervention study comparing an app-based nutrition program with standard therapy involving personal counseling. Eighty adults with a body mass index between 25 and < 35 kg/m² were randomly assigned to one of four groups (1) app-based, (2) individual coaching, (3) general dietary recommendations and (4) control. All intervention groups received individualized, nutrient-optimized menu plans with integrated flaxseed oil supplementation, either via app or in printed form, combined with varying levels of counseling.

Energy intake was gradually reduced every 4 weeks, with maintenance phases at the beginning and end of the 16-week intervention. Anthropometric and biochemical parameters were measured at four-week intervals.</p>Results<p>After 12 weeks of energy reduction, weight loss was significantly greater in the intervention groups (−6.5 %, −7.3 %, −6.0 %) than in the control group (−2.1 %; p < 0.001) and remained stable during the maintenance phase (16 weeks; all p < 0.01).

A clinically relevant (> 5 %) weight loss was achieved by 66.7 %, 78.9 %, and 53.3 % of participants for all interventions, respectively. Blood pressure was reduced in all intervention groups (p < 0.05), while the values differ not significantly from control group. Total and LDL cholesterol decreased in group 2 and 3 (p < 0.05), the changes differ significantly from the control group.

Group 1 exhibited a significant decrease in fasting glucose and HOMA-IR compared to the other groups. α-Linolenic concentrations increased markedly (+ 52.7–79.4 %; p ≤ 0.01), whereas eicosapentaenoic acid and docosahexaenoic acid remained unchanged. No relevant changes were observed in micronutrient status.</p>Conclusion<p>The intervention groups achieved clinically meaningful weight loss and an improvement in blood lipid levels.

The greatest effect is likely attributable to the individualized, nutrient-optimized menu plans rather than the type of counseling or delivery mode.</p>Clinical trial registration<p>clinicaltrials.gov/, identifier NCT04717076</p>