PrevA Study - Evaluation of an App-based Nutritional Concept

Study Overview
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Brief Summary
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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
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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.

Official Title
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PrevA Study - Evaluation of an App-based Nutritional Concept to Lower Cardiovascular Risk Factors (Focus: Weight Reduction)

Conditions
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Reduction of Cardiovascular Risk Factors

Intervention / Treatment
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* Behavioral: App-based nutritional concept and fitness tracking
* Behavioral: Nutritional concept with individual nutritional counselling
* Behavioral: Nutritional concept without individual nutritional counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: App-based nutritional concept and fitness tracking<br>App-based nutritional concept and fitness tracking | Behavioral: App-based nutritional concept and fitness tracking<br>* 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.<br>|
| Experimental: Nutritional concept with individual nutritional counselling<br>Nutritional concept with individual nutritional counselling | Behavioral: Nutritional concept with individual nutritional counselling<br>* Nutritional concept based on personalized menu plans and individual nutritional counselling every four weeks (4 times during the study)<br>|
| Experimental: Nutritional concept without individual nutritional counselling<br>Nutritional concept without individual nutritional counselling | Behavioral: Nutritional concept without individual nutritional counselling<br>* Nutritional concept based on personalized menu plans<br>|
| No Intervention: Control group<br>Control group - no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight (kg) | change from baseline after 4, 8, 12, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat | Body fat (%) | change from baseline after 4, 8, 12, 16 weeks | 
| Systolic blood pressure | systolic pressure (mm Hg) | change from baseline after 4, 8, 12, 16 weeks | 
| Diastolic blood pressure | diastolic blood pressure (mm Hg) | change from baseline after 4, 8, 12, 16 weeks | 
| Basal metabolic rate | Basal metabolic rate (kcal per day) - measurement: indirect calorimetry | change from baseline after 4, 8, 12, 16 weeks | 
| Total cholesterol (plasma) | Total cholesterol (mmol/l) | change from baseline after 4, 8, 12, 16 weeks | 
| LDL cholesterol (plasma) | LDL cholesterol (mmol/l) | change from baseline after 4, 8, 12, 16 weeks | 
| HDL cholesterol (plasma) | HDL cholesterol (mmol/l) | change from baseline after 4, 8, 12, 16 weeks | 
| Triacylglycerides (plasma) | Triacylglycerides (mmol/l) | change from baseline after 4, 8, 12, 16 weeks | 
| Glucose (fasting) (serum) | Glucose (mmol/l) | change from baseline after 4, 8, 12, 16 weeks | 
| Insulin (fasting) (serum) | Insulin (mU/l) | change from baseline after 4, 8, 12, 16 weeks | 
| HbA1c (serum) | HbA1c (%) | change from baseline after 4, 8, 12, 16 weeks | 
| alpha prothrombin time (serum) | alpha prothrombin time (s) | change from baseline after 4, 8, 12, 16 weeks | 
| Fibrinogen (serum) | Fibrinogen (g/l) | change from baseline after 4, 8, 12, 16 weeks | 
| High sensitive c-reactive protein (plasma) | High sensitive c-reactive protein (mg/l) | change from baseline after 4, 8, 12, 16 weeks | 
| Homocysteine (serum) | Homocysteine (µmol/l) | change from baseline after 4, 8, 12, 16 weeks | 
| Triiodothyronine (plasma) | Triiodothyronine fT3 (pmol/l) | change from baseline after 16 weeks | 
| Thyroxine (plasma) | Thyroxine fT4 (pmol/l) | change from baseline after 16 weeks | 
| Thyroid-stimulating hormone (plasma) | Thyroid-stimulating hormone (mU/l) | change from baseline after 16 weeks | 
| Parathyroid hormone (plasma) | Parathyroid hormone (ng/l) | change from baseline after 16 weeks | 
| Alkaline phosphatase (serum) | Alkaline phosphatase (µg/l) | change from baseline after 16 weeks | 
| Osteocalcin (serum) | Osteocalcin (ng/ml) | change from baseline after 16 weeks | 
| Uric acid (plasma) | Uric acid (µmol/l) | change from baseline after 16 weeks | 
| Alanine aminotransferase (plasma) | Alanine aminotransferase (µmol/l*s) | change from baseline after 4, 8, 12, 16 weeks | 
| Aspartate transaminase (plasma) | Aspartate transaminase (µmol/l*s) | change from baseline after 4, 8, 12, 16 weeks | 
| Cholinesterase (plasma) | Cholinesterase (µmol/l*s) | change from baseline after 4, 8, 12, 16 weeks | 
| Gamma-glutamyltransferase (plasma) | Gamma-glutamyltransferase (µmol/l*s) | change from baseline after 4, 8, 12, 16 weeks | 
| Lactate dehydrogenase (plasma) | Lactate dehydrogenase (µmol/l*s) | change from baseline after 4, 8, 12, 16 weeks | 
| Fatty acid distribution in plasma lipids (plasma) | Fatty acid distribution in plasma lipids (% fatty acid methyl esters) | change from baseline after 4, 8, 12, 16 weeks | 
| Fatty acid distribution in erythrocyte lipids (erythrocytes) | Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters) | change from baseline after 4, 8, 12, 16 weeks | 
| Vitamin A (serum) | Vitamin A (mmol/l) | change from baseline after 16 weeks | 
| Vitamin D (plasma) | Vitamin D (nmol/l) | change from baseline after 16 weeks | 
| Vitamin E (serum) | Vitamin E (µmol/l) | change from baseline after 16 weeks | 
| Vitamin B1 (serum) | Vitamin B1 (nmol/l) | change from baseline after 16 weeks | 
| Vitamin B2 (serum) | Vitamin B2 (nmol/l) | change from baseline after 16 weeks | 
| Vitamin B6 (serum) | Vitamin B6 (nmol/l) | change from baseline after 16 weeks | 
| Vitamin B12 (plasma) | Vitamin B12 (pmol/l) | change from baseline after 16 weeks | 
| Holo-transcobalamin (plasma) | Holo-transcobalamin (pmol/l) | change from baseline after 16 weeks | 
| Folic acid (plasma) | Folic acid (µg/l) | change from baseline after 16 weeks | 
| Vitamin H (serum) | Vitamin H (ng/l) | change from baseline after 16 weeks | 
| Vitamin C (plasma) | Vitamin C (mg/l) | change from baseline after 16 weeks | 
| Calcium (plasma) | Calcium (mmol/l) | change from baseline after 16 weeks | 
| Potassium (plasma) | Potassium (mmol/l) | change from baseline after 16 weeks | 
| Iron (plasma) | Iron (µmol/l) | change from baseline after 4, 8, 12, 16 weeks | 
| Ferritin (plasma) | Ferritin (µg/l) | change from baseline after 4, 8, 12, 16 weeks | 
| Transferrin (plasma) | Transferrin (g/l) | change from baseline after 4, 8, 12, 16 weeks | 
| Iodine (serum) | Iodine (µmol/l) | change from baseline after 16 weeks | 
| Selenium (serum) | Selenium (µmol/l) | change from baseline after 16 weeks | 
| Zinc (serum) | Zinc (µmol/l) | change from baseline after 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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personalized nutritional concept, weight reduction, mHealth