PrevA Study - Evaluation of an App-based Nutritional Concept
NCT ID: NCT04717076
Last Updated: 2022-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2021-04-12
2021-10-12
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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App-based nutritional concept and fitness tracking
App-based nutritional concept and fitness tracking
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.
Nutritional concept with individual nutritional counselling
Nutritional concept with individual nutritional counselling
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)
Nutritional concept without individual nutritional counselling
Nutritional concept without individual nutritional counselling
Nutritional concept without individual nutritional counselling
Nutritional concept based on personalized menu plans
Control group
Control group - no intervention
No interventions assigned to this group
Interventions
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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.
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)
Nutritional concept without individual nutritional counselling
Nutritional concept based on personalized menu plans
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
69 Years
ALL
Yes
Sponsors
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University of Jena
OTHER
Responsible Party
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Christine Dawczynski,PhD
PhD, Head of Junior Research Group Nutritional Concepts, University of Jena
Principal Investigators
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Christine Dawczynski, PhD
Role: PRINCIPAL_INVESTIGATOR
Friedrich-Schiller-University
Locations
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Friedrich-Schiller University
Jena, Thuringia, Germany
Countries
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Other Identifiers
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H11_21
Identifier Type: -
Identifier Source: org_study_id
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