PrevA Study - Evaluation of an App-based Nutritional Concept
Condition: Reduction of Cardiovascular Risk Factors
Study type: Interventional

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.
    

Detailed description: 
      Smartphone-based communication technologies are developing rapidly, and the number of
      so-called mobile health applications is rising. The number of validated and scientifically
      tested offers is comparatively small. To address this weak point, we developed a personalized
      nutritional concept to implement a heart-healthy diet. In cooperation with the Preventicus
      GmbH, Jena, the concept was integrated in an App-based tool. In addition, the app relates to
      a smartwatch to encourage and track physical activity. The PrevA study will be conducted to
      evaluate the overall concept.

      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 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.

      In groups 1 to 3, the daily plans are issued in 4 energy levels. At the beginning, the test
      subjects receive daily plans according to the recommendations for energy intake of the German
      Nutrition Society (DGE), adapted to their age, gender, and activity level (level 1). After
      four study weeks, the energy content of the plans is reduced to 85% of the energy intake
      recommended by the DGE (level 2) and after further four weeks of the PrevA study the energy
      level is reduced to 70% of the energy intake recommended by the DGE (level 3). Level 4 serves
      as a stabilization phase and provides the energy content of level 1. The study period extends
      over a total of 16 study weeks. During this time, blood samples and urine are collected every
      four weeks to analyze the study parameters. In addition, anthropometric data, data on
      personal health status and cardiovascular risk profile are assessed.
    

Intervention name(s): App-based nutritional concept and fitness tracking; Nutritional concept with individual nutritional counselling; Nutritional concept without individual nutritional counselling
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; Nutritional concept based on personalized menu plans and individual nutritional counselling every four weeks (4 times during the study); Nutritional concept based on personalized menu plans
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: personalized nutritional concept, weight reduction, mHealth