Reduction of Cardiovascular Risk FactorsPrevANCT04717076
PrevA Study - Evaluation of an App-based Nutritional Concept
A study testing App-based nutritional concept and fitness tracking, Nutritional concept with individual nutritional counselling and Nutritional concept without individual nutritional counselling in people with Reduction of Cardiovascular Risk Factors, run by University of Jena at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Reduction of Cardiovascular Risk Factors
- What is being tested?
- App-based nutritional concept and fitness tracking, Nutritional concept with individual nutritional counselling and Nutritional concept without individual nutritional counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 12 Apr 2021to 12 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Reduction of Cardiovascular Risk Factors
- Being tested
- App-based nutritional concept and fitness tracking, Nutritional concept with individual nutritional counselling, Nutritional concept without individual nutritional counselling
- Keywords
- personalized nutritional concept, weight reduction, mHealth
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based nutritional concept and fitness trackingBehavioural
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 counsellingBehavioural
Nutritional concept based on personalized menu plans and individual nutritional counselling every four weeks (4 times during the study)
Nutritional concept without individual nutritional counsellingBehavioural
Nutritional concept based on personalized menu plans
| Study group | Role | What they receive |
|---|---|---|
| App-based nutritional concept and fitness tracking | Active comparator | App-based nutritional concept and fitness tracking Receives: Behavioral: App-based nutritional concept and fitness tracking |
| Nutritional concept with individual nutritional counselling | Experimental | Nutritional concept with individual nutritional counselling Receives: Behavioral: Nutritional concept with individual nutritional counselling |
| Nutritional concept without individual nutritional counselling | Experimental | Nutritional concept without individual nutritional counselling Receives: Behavioral: Nutritional concept without individual nutritional counselling |
| Control group | No intervention | Control group - no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight (kg)
Measured: change from baseline after 4, 8, 12, 16 weeks
Secondary outcomes (48)
Body fat
Body fat (%)
Measured: change from baseline after 4, 8, 12, 16 weeks
Systolic blood pressure
systolic pressure (mm Hg)
Measured: change from baseline after 4, 8, 12, 16 weeks
Diastolic blood pressure
diastolic blood pressure (mm Hg)
Measured: change from baseline after 4, 8, 12, 16 weeks
Basal metabolic rate
Basal metabolic rate (kcal per day) - measurement: indirect calorimetry
Measured: change from baseline after 4, 8, 12, 16 weeks
Total cholesterol (plasma)
Total cholesterol (mmol/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
LDL cholesterol (plasma)
LDL cholesterol (mmol/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
HDL cholesterol (plasma)
HDL cholesterol (mmol/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
Triacylglycerides (plasma)
Triacylglycerides (mmol/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
Glucose (fasting) (serum)
Glucose (mmol/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
Insulin (fasting) (serum)
Insulin (mU/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
HbA1c (serum)
HbA1c (%)
Measured: change from baseline after 4, 8, 12, 16 weeks
alpha prothrombin time (serum)
alpha prothrombin time (s)
Measured: change from baseline after 4, 8, 12, 16 weeks
Fibrinogen (serum)
Fibrinogen (g/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
High sensitive c-reactive protein (plasma)
High sensitive c-reactive protein (mg/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
Homocysteine (serum)
Homocysteine (µmol/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
Triiodothyronine (plasma)
Triiodothyronine fT3 (pmol/l)
Measured: change from baseline after 16 weeks
Thyroxine (plasma)
Thyroxine fT4 (pmol/l)
Measured: change from baseline after 16 weeks
Thyroid-stimulating hormone (plasma)
Thyroid-stimulating hormone (mU/l)
Measured: change from baseline after 16 weeks
Parathyroid hormone (plasma)
Parathyroid hormone (ng/l)
Measured: change from baseline after 16 weeks
Alkaline phosphatase (serum)
Alkaline phosphatase (µg/l)
Measured: change from baseline after 16 weeks
Osteocalcin (serum)
Osteocalcin (ng/ml)
Measured: change from baseline after 16 weeks
Uric acid (plasma)
Uric acid (µmol/l)
Measured: change from baseline after 16 weeks
Alanine aminotransferase (plasma)
Alanine aminotransferase (µmol/l*s)
Measured: change from baseline after 4, 8, 12, 16 weeks
Aspartate transaminase (plasma)
Aspartate transaminase (µmol/l*s)
Measured: change from baseline after 4, 8, 12, 16 weeks
Cholinesterase (plasma)
Cholinesterase (µmol/l*s)
Measured: change from baseline after 4, 8, 12, 16 weeks
Gamma-glutamyltransferase (plasma)
Gamma-glutamyltransferase (µmol/l*s)
Measured: change from baseline after 4, 8, 12, 16 weeks
Lactate dehydrogenase (plasma)
Lactate dehydrogenase (µmol/l*s)
Measured: 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)
Measured: 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)
Measured: change from baseline after 4, 8, 12, 16 weeks
Vitamin A (serum)
Vitamin A (mmol/l)
Measured: change from baseline after 16 weeks
Vitamin D (plasma)
Vitamin D (nmol/l)
Measured: change from baseline after 16 weeks
Vitamin E (serum)
Vitamin E (µmol/l)
Measured: change from baseline after 16 weeks
Vitamin B1 (serum)
Vitamin B1 (nmol/l)
Measured: change from baseline after 16 weeks
Vitamin B2 (serum)
Vitamin B2 (nmol/l)
Measured: change from baseline after 16 weeks
Vitamin B6 (serum)
Vitamin B6 (nmol/l)
Measured: change from baseline after 16 weeks
Vitamin B12 (plasma)
Vitamin B12 (pmol/l)
Measured: change from baseline after 16 weeks
Holo-transcobalamin (plasma)
Holo-transcobalamin (pmol/l)
Measured: change from baseline after 16 weeks
Folic acid (plasma)
Folic acid (µg/l)
Measured: change from baseline after 16 weeks
Vitamin H (serum)
Vitamin H (ng/l)
Measured: change from baseline after 16 weeks
Vitamin C (plasma)
Vitamin C (mg/l)
Measured: change from baseline after 16 weeks
Calcium (plasma)
Calcium (mmol/l)
Measured: change from baseline after 16 weeks
Potassium (plasma)
Potassium (mmol/l)
Measured: change from baseline after 16 weeks
Iron (plasma)
Iron (µmol/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
Ferritin (plasma)
Ferritin (µg/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
Transferrin (plasma)
Transferrin (g/l)
Measured: change from baseline after 4, 8, 12, 16 weeks
Iodine (serum)
Iodine (µmol/l)
Measured: change from baseline after 16 weeks
Selenium (serum)
Selenium (µmol/l)
Measured: change from baseline after 16 weeks
Zinc (serum)
Zinc (µmol/l)
Measured: change from baseline after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start12 Apr 2021
- Primary completion12 Aug 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reduction of Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Dawczynski,PhD, University of Jena
- Investigators
- Christine Dawczynski, PhD, Principal investigator, Friedrich-Schiller-University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717076
- Sponsor's protocol ID
- H11_21
- Acronym
- PrevA
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klein L, Biernath M, Kipp K, Kiehntopf M, Scherag S, Meier K, Hubner T, Lorkowski S, Dawczynski C. A randomized parallel-designed study evaluating the effect of an app-based nutritional concept for weight reduction and further cardiovascular risk factors: Insights from the PreVA study. Front Nutr. 2026 Sep 23;13:1815820. doi: 10.3389/fnut.2026.1815820. eCollection 2026.
PubMed 42846999
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrevA Study - Evaluation of an App-based Nutritional Concept to Lower Cardiovascular Risk Factors (Focus: Weight Reduction)
- ClinicalTrials.gov ID
- NCT04717076
- Acronym / sponsor ID
- PrevA / H11_21
- Conditions
- Reduction of Cardiovascular Risk Factors
- Keywords
- personalized nutritional concept, weight reduction, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| App-based nutritional concept and fitness tracking | Active comparator | Behavioral: App-based nutritional concept and fitness trackingApp-based nutritional concept and fitness tracking |
| Nutritional concept with individual nutritional counselling | Experimental | Behavioral: Nutritional concept with individual nutritional counsellingNutritional concept with individual nutritional counselling |
| Nutritional concept without individual nutritional counselling | Experimental | Behavioral: Nutritional concept without individual nutritional counsellingNutritional concept without individual nutritional counselling |
| Control group | No intervention | –Control group - no intervention |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based nutritional concept and fitness trackingThe 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. | Behavioural | App-based nutritional concept and fitness tracking |
| Nutritional concept with individual nutritional counsellingNutritional concept based on personalized menu plans and individual nutritional counselling every four weeks (4 times during the study) | Behavioural | Nutritional concept with individual nutritional counselling |
| Nutritional concept without individual nutritional counsellingNutritional concept based on personalized menu plans | Behavioural | Nutritional concept without individual nutritional counselling |
Primary outcome
Body weight
Time frame: change from baseline after 4, 8, 12, 16 weeks
Body weight (kg)
48 secondary outcomes
Body fat
Time frame: change from baseline after 4, 8, 12, 16 weeks
Systolic blood pressure
Time frame: change from baseline after 4, 8, 12, 16 weeks
Diastolic blood pressure
Time frame: change from baseline after 4, 8, 12, 16 weeks
Basal metabolic rate
Time frame: change from baseline after 4, 8, 12, 16 weeks
Total cholesterol (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
LDL cholesterol (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
HDL cholesterol (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Triacylglycerides (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Glucose (fasting) (serum)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Insulin (fasting) (serum)
Time frame: change from baseline after 4, 8, 12, 16 weeks
HbA1c (serum)
Time frame: change from baseline after 4, 8, 12, 16 weeks
alpha prothrombin time (serum)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Fibrinogen (serum)
Time frame: change from baseline after 4, 8, 12, 16 weeks
High sensitive c-reactive protein (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Homocysteine (serum)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Triiodothyronine (plasma)
Time frame: change from baseline after 16 weeks
Thyroxine (plasma)
Time frame: change from baseline after 16 weeks
Thyroid-stimulating hormone (plasma)
Time frame: change from baseline after 16 weeks
Parathyroid hormone (plasma)
Time frame: change from baseline after 16 weeks
Alkaline phosphatase (serum)
Time frame: change from baseline after 16 weeks
Osteocalcin (serum)
Time frame: change from baseline after 16 weeks
Uric acid (plasma)
Time frame: change from baseline after 16 weeks
Alanine aminotransferase (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Aspartate transaminase (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Cholinesterase (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Gamma-glutamyltransferase (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Lactate dehydrogenase (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Fatty acid distribution in plasma lipids (plasma)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Fatty acid distribution in erythrocyte lipids (erythrocytes)
Time frame: change from baseline after 4, 8, 12, 16 weeks
Vitamin A (serum)
Time frame: change from baseline after 16 weeks
Vitamin D (plasma)
Time frame: change from baseline after 16 weeks
Vitamin E (serum)
Time frame: change from baseline after 16 weeks
Vitamin B1 (serum)
Time frame: change from baseline after 16 weeks
Vitamin B2 (serum)
Time frame: change from baseline after 16 weeks
Vitamin B6 (serum)
Time frame: change from baseline after 16 weeks
Vitamin B12 (plasma)
Time frame: change from baseline after 16 weeks
Holo-transcobalamin (plasma)
Time frame: change from baseline after 16 weeks
Folic acid (plasma)
Time frame: change from baseline after 16 weeks
Vitamin H (serum)
Time frame: change from baseline after 16 weeks
Vitamin C (plasma)
Time frame: change from baseline after 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Derived from this study: PubMed 42846999Klein L, Biernath M, Kipp K, Kiehntopf M, Scherag S, Meier K, Hubner T, Lorkowski S, Dawczynski C. A randomized parallel-designed study evaluating the effect of an app-based nutritional concept for weight reduction and further cardiovascular risk factors: Insights from the PreVA study. Front Nutr. 2026 Sep 23;13:1815820. doi: 10.3389/fnut.2026.1815820. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Dawczynski, PhD principal investigator
Friedrich-Schiller-University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based nutritional concept and fitness tracking, Nutritional concept with individual nutritional counselling and Nutritional concept without individual nutritional counselling in people with Reduction of Cardiovascular Risk Factors, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: change from baseline after 4, 8, 12, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04717076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.