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PrevA Study - Evaluation of an App-based Nutritional Concept

NCT04717076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-03-03

No results posted yet for this study

Summary

The PrevA study is designed to evaluate our developed nutritional concept to implement a heart healthy diet. The nutritional concept based on nutrient-optimized daily menu plans for each study day. The plans are personalized according to participants age, gender, and level of physical activity. The PrevA study consists of four periods differing in the energy intake specified by the menu plans.

The study is carried out in a 4-armed parallel design. In group 1, the participants receive the individualized daily plans via the app coupled with the smartwatch to record participants physical activity and heart rate. Groups 2 and 3 receive a printed version of the daily plans with or without personal nutritional advice. The fourth group serves as a control group, which receives general nutritional recommendations but no daily menu plans. During this time, blood samples and urine are collected every four weeks to analyze the study parameters.

Conditions

  • Reduction of Cardiovascular Risk Factors

Interventions

BEHAVIORAL

App-based nutritional concept and fitness tracking

The App-based nutritional concept based on menu plan, which are personalized according to participants age, gender, physical activity. The App is coupled with a Smartwatch to encourage and track physical activity over the study period.

BEHAVIORAL

Nutritional concept with individual nutritional counselling

Nutritional concept based on personalized menu plans and individual nutritional counselling every four weeks (4 times during the study)

BEHAVIORAL

Nutritional concept without individual nutritional counselling

Nutritional concept based on personalized menu plans

Sponsors & Collaborators

  • University of Jena

    lead OTHER

Principal Investigators

  • Christine Dawczynski, PhD · Friedrich-Schiller-University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2021-08-12
Completion
2021-10-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04717076 on ClinicalTrials.gov