PrevA Study - Evaluation of an App-based Nutritional Concept

University of Jena

Status: Completed

Conditions: Reduction of Cardiovascular Risk Factors

Treatments: Behavioral: App-based nutritional concept and fitness tracking; Behavioral: Nutritional concept with individual nutritional counselling; Behavioral: Nutritional concept without individual nutritional counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT04717076

H11_21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 20 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Voluntary participation with documented informed consent
• Willingness and ability to adhere to the study protocol
• Males / female) aged ≥ 20 years and ≤ 51 years
• BMI: ≥ 25 ≤ 35 kg / m2 (obesity grade 1)
• Owning a smartphone (android)
• no or moderate alcohol consumption (≤ 2 glasses / week)
• non-smoker (if possible)

Exclusion criteria

Comorbidities:

• Hypercholesterolemia (genetic defect / familial predisposition)
• Diabetes mellitus type 1 or 2
• Thyroid dysfunction (hyper- or hypothyroidism)
• Food intolerance / allergies to ingredients in the study foods
• Medications: lipid-lowering drugs, glucocorticoids
• Dietary supplements: especially n-3 fatty acids, vitamin E.
• Extremely high physical activity (daily)
• Alcohol abuse (daily)
• (smoker) [if there are not enough test persons available, > 7 smokers should be included so that a statistical analysis is possible]
• Uncontrolled organic diseases
• Alcohol, drug or drug abuse
• Participation in other clinical observational studies during or 4 weeks. before starting this study
• Serious behavioral problems, emotional problems or psychiatric problems which the investigator believes would lead to a lack of compliance
• Pregnancy, breastfeeding and unsafe contraception
• Other reasons that are considered important by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

App-based nutritional concept and fitness tracking

Active Comparator group

Description:

App-based nutritional concept and fitness tracking

Treatment:

Behavioral: App-based nutritional concept and fitness tracking

Nutritional concept with individual nutritional counselling

Experimental group

Description:

Nutritional concept with individual nutritional counselling

Treatment:

Behavioral: Nutritional concept with individual nutritional counselling

Nutritional concept without individual nutritional counselling

Experimental group

Description:

Nutritional concept without individual nutritional counselling

Treatment:

Behavioral: Nutritional concept without individual nutritional counselling

Control group

No Intervention group

Description:

Control group - no intervention