Depressive/Anxiety SymptomsLIDIASNCT07022184
Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice
A study testing Personalized Lifestyle Intervention in people with Depressive/Anxiety Symptoms and Depressive Disorder, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial summary
The goal of this clinical trial is to find out whether a smartphone app can help reduce symptoms of depression by supporting healthy lifestyle changes and encouraging self-monitoring in adults who visit their general practitioner with symptoms of depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive/Anxiety Symptoms, Depressive Disorder
- What is being tested?
- Personalized Lifestyle Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 3 sitesNetherlands
- Study dates
- 17 Jun 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently experiencing an episode of symptoms of depression and receiving treatment for this episode from their GP or GP-MHW for less than six months
- Have a smartphone
- Be proficient in Dutch
Who cannot join
- Severe mental illness (such as psychosis or bipolar disorder)
- Severe alcohol or drug addiction requiring specialized secondary care
- High suicide risk
- moderate to severe cognitive impairment (as determined by the GP)
- Patients who visit their GP for depressive symptoms but with a PHQ-9 of <5 at baseline are allowed to use the PLI, but will not be included in the primary analysis.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Suzanne Ligthart contact
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105 AZ
Otto Maarsingh, o.maarsingh@amsterdamumc.nl
- Recruiting
UMC Groningen
Groningen, Provincie Groningen, 9713 GZ
Huib Burger, h.burger@umcg.nl
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525GA
Eline Jagtenberg, 0652902132, eline.jagtenberg@radboudumc.nl
About this study
Official title: A Personalized Lifestyle Intervention for Depression Symptomatology in General Practice - a Cluster Randomized Multicenter Trial
The goal of this clinical trial is to find out whether a smartphone app can help reduce symptoms of depression by supporting healthy lifestyle changes and encouraging self-monitoring in adults who visit their general practitioner with symptoms of depression.
The main questions this study aims to answer are:
Read more
Does a personalized lifestyle intervention delivered through the app, in addition to regular care, reduce depression symptoms more effectively than regular care alone? Is this approach more cost-effective than regular care alone?
Researchers will compare patients who use the app alongside their regular care to patients who receive regular care without the app, to see whether the app leads to better outcomes.
Participants who use the app will:
Complete a lifestyle questionnaire focused on six themes: mental wellbeing, use of harmful substances, social relationships, healthy eating, sleep, and physical activity.
Set personal goals based on their results and receive tailored lifestyle advice.
Track their depression symptoms regularly within the app to support ongoing care.
Have follow-up conversations with their general practitioner or mental health nurse to discuss their progress.
Fill out questionnaires about their symptoms and experiences during the study.
- Conditions
- Depressive/Anxiety Symptoms, Depressive Disorder
- Being tested
- Personalized Lifestyle Intervention
- Keywords
- Personalized lifestyle intervention, eHealth, Measurement-based care, Depression symptomatology, Cluster randomized trial, General practice, Lifestyle changes, Mental health support, Primary care
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Lifestyle InterventionDevice
Also called Patient Journey App, Lifestyle App, PLI
The personalized lifestyle intervention (PLI) consists of the combined use of the Patient Journey App (PJA) alongside care provided by the general practitioner or mental health nurse.
The Patient Journey App integrates four digital health tools within a single smartphone application:
- A brief lifestyle questionnaire covering six key areas: mental wellbeing, minimizing harmful substance use, social relationships, healthy eating, sleep, and physical activity.
- A personalized summary of the questionnaire results, which supports the formulation of two personal lifestyle goals.
- Tailored information and advice about lifestyle, including suggested interventions, based on the patient's personal goals.
- Monitoring of depression symptoms over time to support measurement-based care.
General practitioners and mental health nurses will have access to the app to monitor patient progress and outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Care As Usual (CAU) | No intervention | The control group, receiving care as usual, will use a version of the Patient Journey App that only displays study questionnaires and sends reminders to complete them at the start of the study, and again at 3 and 6 months. Every 6 weeks, depression symptoms are measured. Patients can view their depression questionnaire results (PHQ-9; Patient Health Questionnaire-9) in a graph within the app. General practitioners and mental health nurses will not have access to the app. At 12 months, all participants will be invited to complete an optional final questionnaire about (cost-)effectiveness to assess the long-term impact of the intervention. |
| Personalized Lifestyle Intervention | Experimental | The intervention group will receive the personalized lifestyle intervention (PLI) in addition to care as usual. The PLI consists of the combined use of the Patient Journey App and regular treatment provided by the general practitioner or mental health nurse in general practice. Patients, general practitioners and mental health nurses will have access to the app to monitor patient progress and outcomes (symptoms of depression and anxiety). Study questionnaires will be completed at the start of the study (baseline), and again at 3, 6, and optionally 12 months after enrollment. Every 6 weeks, depression symptoms are measured. Receives: Device: Personalized Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness of the Personalized Lifestyle Intervention at 6 months after baseline
To assess the PLI's cost-effectiveness from a societal perspective, the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) will be used. The main outcome in the cost-effectiveness analysis is Quality-Adjusted Life-Years (QALYs) based on the EQ-5D-5L, measuring general quality of life.
Also, additional treatments are measured within the TIC-P, for secondary analysis on additional care.
Measured: Baseline to 6 months
Change in quality of life using the EQ-5D-5L
Change in quality of life will be assessed using the EQ-5D-5L. This tool consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each rated on a 5-level scale. The EQ-5D-5L also includes a visual analog scale (VAS) to assess overall health. Higher scores indicate better quality of life, while lower scores reflect greater limitations or discomfort. This measure helps track changes in health status and overall quality of life over time.
Measured: Baseline to 6 months
Change from baseline in the mean depression severity score measured by the PHQ-9 at 6 months after baseline
To evaluate the effectiveness of the PLI on depression symptomatology, general symptoms of depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-reported questionnaire assessing the severity of depression symptomatology. The PHQ-9 is brief, easy to complete, and takes only a few minutes to fill out. The total score ranges from 0 to 27. Scores are interpreted as follows: 0-4 indicates minimal or no depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. Higher scores suggest more severe symptoms, and professional treatment is recommended as the score increases.
Measured: Baseline to 6 months.
Secondary outcomes (12)
Change in the severity of anxiety symptoms: GAD-7 (Generalized Anxiety Disorder-7)
To measure the severity of anxiety symptoms, the GAD-7 (Generalized Anxiety Disorder-7) will be used
Measured: Baseline to 3 , 6 and 12 months
Changes in quality of life according to the Recovering Quality of Life (ReQol)
Quality of life is measured using the Recovering Quality of Life (ReQol) questionnaire, a patient-reported outcome measure specifically developed for individuals with various mental health conditions. The ReQol provides a total score ranging from 0 to 80, with higher scores reflecting a better quality of life and overall recovery outcome.
Measured: Baseline to 3, 6 and 12 months
Change in use of antidepressants
Use of antidepressants, when started/ended, type, dosage, and at follow-up: inquire about changes.
Measured: Baseline to 3 and 6 months
Change in use of anxiolytics
Use of anxiolytics by self-reported questions about the use of sedatives/sleep medication, when started/ended, frequency of use, type, dosage, and at follow-up: inquire about changes.
Measured: Baseline to 3 and 6 months
Change in lifestyle measures at month 6
Self-constructed questions about the daily lifestyle habits of all participants. The lifestyle components addressed include smoking, alcohol consumption, drug use, sleep duration, adherence to the Dutch Physical Activity Guidelines according to the Dutch National Institute for Public Health and the Environment (RIVM), and nutrition based on the dietary recommendations of the Netherlands Nutrition Centre.
Measured: Baseline to 6 months
Change in BMI
Weight and height will be combined to report BMI (Body Mass Index) in kg/m^2.
Measured: Baseline to 6 months
Change in lifestyle satisfaction measures at month 6 (intervention arm)
In the intervention group, self-constructed questions about lifestyle are used to measure a patient's satisfaction with specific lifestyle components on a scale from 0 to 10, where 10 indicates the highest level of satisfaction. The lifestyle components include mental wellbeing, minimizing harmful substances, social relationships, healthy eating, sleep, and physical activity. It is possible that someone smokes but is currently satisfied with this and does not wish to make any changes. The intervention is not intended to impose certain behaviors but rather to address the lifestyle components that the individual is willing and motivated to improve, with the ultimate goal of reducing depressive symptoms. These questions collectively provide an overview that the healthcare provider and patient can use together to set achievable goals. In the control group, this questionnaire will only be completed at month 6 of the study.
Measured: Baseline (intervention only) and 6 months (both groups)
Patient satisfaction: CQi (Consumer Quality Index)
The Consumer Quality Index (CQI) is a 16-item questionnaire that evaluates patient experiences and satisfaction across various dimensions, such as communication, access to care, and treatment outcomes. The CQI helps healthcare providers track patient experiences and identify opportunities for enhancing care. It has a 5 point scale. The last item is a scoring item for overall treatment satisfaction. Higher scores indicate better satisfaction, while lower scores highlight areas for improvement.
Measured: At 6 months
Change in patient-doctor relationship: PDRQ-9
The Patient-Doctor-Relationship Questionnaire (PDRQ-9) is a patient-reported outcome measure used to assess the quality of the therapeutic relationship between patients and their healthcare providers, such as general practitioners (GPs) or mental health nurses (GP-MHNs). The questionnaire evaluates key aspects of the patient-provider interaction, helping to capture the perceived level of trust, support, and communication. The score ranges from 9 to 45, higher score indicating a more positive relationship according to the patient.
Measured: Baseline to 6 months
Change in social support: SSL12 (Social Support List-12)
Social support will be measured using the SSL12 (Social Support List-12) questionnaire. This validated tool assesses perceived social support across various domains, such as emotional, practical, and informational support. Higher scores indicate greater perceived social support, while lower scores suggest limited support. The SSL12 helps evaluate the level of social assistance individuals feel they receive and can track changes in social support over time.
Measured: Baseline to 6 months
PHQ-9 at 3 and 12 months
Secondary analysis of PHQ-9 outcomes. To evaluate the effectiveness of the PLI on depression symptomatology, general symptoms of depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9) every 6 weeks. The PHQ-9 is a 9-item self-reported questionnaire assessing the severity of depression symptomatology. The PHQ-9 is brief, easy to complete, and takes only a few minutes to fill out. The total score ranges from 0 to 27. Scores are interpreted as follows: 0-4 indicates minimal or no depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. Higher scores suggest more severe symptoms, and professional treatment is recommended as the score increases.
Measured: Baseline to 6 weeks, 3 months and 12 months
Cost-effectiveness at 3 months and at 12 months
To assess the PLI's cost-effectiveness from a societal perspective, the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) will be used. The main outcome in the cost-effectiveness analysis is Quality-Adjusted Life-Years (QALYs) based on the EQ-5D-5L, measuring general quality of life. At 3 and 12 months, an incremental analysis is done in addition to the cost-effectiveness at 6 months
Measured: baseline to 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start17 Jun 2025
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
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 Depressive/Anxiety SymptomsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ixta Noa, Hogeschool van Arnhem en Nijmegen (HAN), Pro Persona Mental Health Care Foundation, Amsterdam UMC, Interactive Studios, University Medical Center Groningen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022184
- Sponsor's protocol ID
- 2024-17656
- Other IDs
- 10930012310037
- Acronym
- LIDIAS
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jagtenberg EM, Ligthart SA, Muilwijk OG, Akkermans RP, Spoelder M, Burger H, Maarsingh OR, Assendelft WJJ, Hartman TCO. Cost-effectiveness of a smartphone-based personalized lifestyle intervention for symptoms of depression in primary care: protocol for a cluster-randomized controlled trial (LIDIAS). Trials. 2026 May 20;27(1):490. doi: 10.1186/s13063-026-09786-1.
PubMed 42157297
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Lifestyle Intervention for Depression Symptomatology in General Practice - a Cluster Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT07022184
- Acronym / sponsor ID
- LIDIAS / 2024-17656
- Conditions
- Depressive/Anxiety Symptoms, Depressive Disorder
- Keywords
- Personalized lifestyle intervention, eHealth, Measurement-based care, Depression symptomatology, Cluster randomized trial, General practice, Lifestyle changes, Mental health support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Ixta Noa, Hogeschool van Arnhem en Nijmegen (HAN), Pro Persona Mental Health Care Foundation, Amsterdam UMC, Interactive Studios, University Medical Center Groningen
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Jun 2025 (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 goal of this clinical trial is to find out whether a smartphone app can help reduce symptoms of depression by supporting healthy lifestyle changes and encouraging self-monitoring in adults who visit their general practitioner with symptoms of depression.
The main questions this study aims to answer are:
Does a personalized lifestyle intervention delivered through the app, in addition to regular care, reduce depression symptoms more effectively than regular care alone? Is this approach more cost-effective than regular care alone?
Researchers will compare patients who use the app alongside their regular care to patients who receive regular care without the app, to see whether the app leads to better outcomes.
Participants who use the app will:
Complete a lifestyle questionnaire focused on six themes: mental wellbeing, use of harmful substances, social relationships, healthy eating, sleep, and physical activity.
Set personal goals based on their results and receive tailored lifestyle advice.
Track their depression symptoms regularly within the app to support ongoing care.
Have follow-up conversations with their general practitioner or mental health nurse to discuss their progress.
Fill out questionnaires about their symptoms and experiences during the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care As Usual (CAU) | No intervention | –The control group, receiving care as usual, will use a version of the Patient Journey App that only displays study questionnaires and sends reminders to complete them at the start of the study, and again at 3 and 6 months. Every 6 weeks, depression symptoms are measured. Patients can view their depression questionnaire results (PHQ-9; Patient Health Questionnaire-9) in a graph within the app. General practitioners and mental health nurses will not have access to the app. At 12 months, all participants will be invited to complete an optional final questionnaire about (cost-)effectiveness to assess the long-term impact of the intervention. |
| Personalized Lifestyle Intervention | Experimental | Device: Personalized Lifestyle InterventionThe intervention group will receive the personalized lifestyle intervention (PLI) in addition to care as usual. The PLI consists of the combined use of the Patient Journey App and regular treatment provided by the general practitioner or mental health nurse in general practice. Patients, general practitioners and mental health nurses will have access to the app to monitor patient progress and outcomes (symptoms of depression and anxiety). Study questionnaires will be completed at the start of the study (baseline), and again at 3, 6, and optionally 12 months after enrollment. Every 6 weeks, depression symptoms are measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently experiencing an episode of symptoms of depression and receiving treatment for this episode from their GP or GP-MHW for less than six months
- Have a smartphone
- Be proficient in Dutch
Key exclusion criteria (5 listed)
- Severe mental illness (such as psychosis or bipolar disorder)
- Severe alcohol or drug addiction requiring specialized secondary care
- High suicide risk
- moderate to severe cognitive impairment (as determined by the GP)
- Patients who visit their GP for depressive symptoms but with a PHQ-9 of <5 at baseline are allowed to use the PLI, but will not be included in the primary analysis.
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 |
|---|---|---|
| Personalized Lifestyle InterventionAlso: Patient Journey App, Lifestyle App, PLIThe personalized lifestyle intervention (PLI) consists of the combined use of the Patient Journey App (PJA) alongside care provided by the general practitioner or mental health nurse. The Patient Journey App integrates four digital health tools within a single smartphone application: 1. A brief lifestyle questionnaire covering six key areas: mental wellbeing, minimizing harmful substance use, social relationships, healthy eating, sleep, and physical activity. 2. A personalized summary of the questionnaire results, which supports the formulation of two personal lifestyle goals. 3. Tailored information and advice about lifestyle, including suggested interventions, based on the patient's personal goals. 4. Monitoring of depression symptoms over time to support measurement-based care. General practitioners and mental health nurses will have access to the app to monitor patient progress and outcomes. | Device | Personalized Lifestyle Intervention |
Primary outcome
Cost-effectiveness of the Personalized Lifestyle Intervention at 6 months after baseline
Time frame: Baseline to 6 months
To assess the PLI's cost-effectiveness from a societal perspective, the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) will be used. The main outcome in the cost-effectiveness analysis is Quality-Adjusted Life-Years (QALYs) based on the EQ-5D-5L, measuring general quality of life. Also, additional treatments are measured within the TIC-P, for secondary analysis on additional care.
Change in quality of life using the EQ-5D-5L
Time frame: Baseline to 6 months
Change in quality of life will be assessed using the EQ-5D-5L. This tool consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each rated on a 5-level scale. The EQ-5D-5L also includes a visual analog scale (VAS) to assess overall health. Higher scores indicate better quality of life, while lower scores reflect greater limitations or discomfort. This measure helps track changes in health status and overall quality of life over time.
Change from baseline in the mean depression severity score measured by the PHQ-9 at 6 months after baseline
Time frame: Baseline to 6 months.
To evaluate the effectiveness of the PLI on depression symptomatology, general symptoms of depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-reported questionnaire assessing the severity of depression symptomatology. The PHQ-9 is brief, easy to complete, and takes only a few minutes to fill out. The total score ranges from 0 to 27. Scores are interpreted as follows: 0-4 indicates minimal or no depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. Higher scores suggest more severe symptoms, and professional treatment is recommended as the score increases.
12 secondary outcomes
Change in the severity of anxiety symptoms: GAD-7 (Generalized Anxiety Disorder-7)
Time frame: Baseline to 3 , 6 and 12 months
Changes in quality of life according to the Recovering Quality of Life (ReQol)
Time frame: Baseline to 3, 6 and 12 months
Change in use of antidepressants
Time frame: Baseline to 3 and 6 months
Change in use of anxiolytics
Time frame: Baseline to 3 and 6 months
Change in lifestyle measures at month 6
Time frame: Baseline to 6 months
Change in BMI
Time frame: Baseline to 6 months
Change in lifestyle satisfaction measures at month 6 (intervention arm)
Time frame: Baseline (intervention only) and 6 months (both groups)
Patient satisfaction: CQi (Consumer Quality Index)
Time frame: At 6 months
Change in patient-doctor relationship: PDRQ-9
Time frame: Baseline to 6 months
Change in social support: SSL12 (Social Support List-12)
Time frame: Baseline to 6 months
PHQ-9 at 3 and 12 months
Time frame: Baseline to 6 weeks, 3 months and 12 months
Cost-effectiveness at 3 months and at 12 months
Time frame: baseline to 3 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 42157297Jagtenberg EM, Ligthart SA, Muilwijk OG, Akkermans RP, Spoelder M, Burger H, Maarsingh OR, Assendelft WJJ, Hartman TCO. Cost-effectiveness of a smartphone-based personalized lifestyle intervention for symptoms of depression in primary care: protocol for a cluster-randomized controlled trial (LIDIAS). Trials. 2026 May 20;27(1):490. doi: 10.1186/s13063-026-09786-1.
- Study website LIDIASLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Suzanne Ligthart contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Lifestyle Intervention in people with Depressive/Anxiety Symptoms and Depressive Disorder, run by Radboud University Medical Center at 3 sites in Netherlands.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eline Jagtenberg (0652902132, eline.jagtenberg@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness of the Personalized Lifestyle Intervention at 6 months after baseline (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. 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 NCT07022184, 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 22 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.