PrevA Study - Evaluation of an App-based Nutritional Concept (PrevA)

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

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.

Study Overview

• Status: Completed
• Conditions: Reduction of Cardiovascular Risk Factors
• Intervention / Treatment: Behavioral: App-based nutritional concept and fitness tracking; Behavioral: Nutritional concept with individual nutritional counselling; Behavioral: Nutritional concept without individual nutritional counselling

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07743
      • Friedrich-Schiller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: App-based nutritional concept and fitness tracking	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.
EXPERIMENTAL: Nutritional concept with individual nutritional counselling	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)
EXPERIMENTAL: Nutritional concept without individual nutritional counselling	Behavioral: Nutritional concept without individual nutritional counselling; Nutritional concept based on personalized menu plans
NO_INTERVENTION: Control group; Control group - no intervention

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatinine (24 h urine)	Creatinine (mmol/l)	change from baseline after 16 weeks
Albumine (24 h urine)	Albumine (mg/l)	change from baseline after 16 weeks
Selenium (24 h urine)	Selenium (µmol/24 h)	change from baseline after 16 weeks
Zinc (24 h urine)	Zinc (µmol/24 h)	change from baseline after 16 weeks

Collaborators and Investigators

• Sponsor: University of Jena
• Investigators: Principal Investigator: Christine Dawczynski, PhD, Friedrich-Schiller-University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2021
• Primary Completion (ACTUAL): August 12, 2021
• Study Completion (ACTUAL): October 12, 2021

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (ACTUAL): January 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: personalized nutritional concept, weight reduction, mHealth
• Other Study ID Numbers: H11_21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No