Consumer BehaviorNCT05595551
Process and Effect Evaluation of the Project "Aan Tafel in 1,2,3 Euro"
A study testing The intervention "Aan Tafel in 1, 2, 3 euro" in people with Consumer Behavior and Food Selection, run by University Ghent at 1 site in Belgium.
Trial summary
The goal of this research project is to learn what the impact of the specific project "Aan Tafel in 1 2 3 euro" is on the food and meal habits of families of lower SES. Three types of studies will be conducted: WP1) Process evaluation via qualitative research: focus groups and/or individual interviews with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Consumer Behavior, Food Selection
- What is being tested?
- The intervention "Aan Tafel in 1, 2, 3 euro"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2022to 31 Aug 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be registered for the project Aan Tafel in 1-2-3 euro
- Be a member of a family with at least one child under the age of 18 living at home.
- Being Dutch-speaking: thorough knowledge of Dutch in terms of reading/writing/speaking.
- Be over 18 years old and (regularly) responsible for the preparation of the family meals
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supporting Healthy and Sustainable Family Meals Among Parents With Lower Socioeconomic Status: Process and Effect Evaluation of the Project "Aan Tafel in 1,2,3 Euro"
The goal of this research project is to learn what the impact of the specific project "Aan Tafel in 1 2 3 euro" is on the food and meal habits of families of lower SES.
Three types of studies will be conducted:
Read more
WP1) Process evaluation via qualitative research: focus groups and/or individual interviews with participants of Aan Tafel in 1 2 3 euro, and with delegates of the social organizations;
WP2) Effect evaluation via secondary data-analysis of purchase data retrieved from loyalty cards of participants, and of general customers (i.e., control group);
WP3) Process and effect evaluation with a control group in a baseline-post design: the intervention group are participants of the program, and the control group are clients in social organizations, but do not participate in the program.
On the one hand we want to find out if the intervention has an effect on specific determinants (i.e., food literacy, self-efficacy, attitudes, food security) of food behavior/meal prepping behavior and on meal structure of the family (i.e., amount of freshly made meals, amount of meals cooked and consumed together) (WP3), as well as on participants' food choices (WP2). On the other hand we want to find out how participans experience the program, what succes factors and barriers are, as well as how social organizations experience the program (as a partner of Colruyt, and contact person of the vulnerable families) (WP1).
Read the detailed description
"Aan Tafel in 1 2 3 euro" is a project of retailer Colruyt in cooperation with social organizations in Belgium. The project/intervention was launched in 2016 and has been implemented throughout Belgium since. In 2021 about 8000 families have already been subscribed, and the numbers are still growing. Families with a lower SES (vulnerable families) are informed by a social organization (OCMW, CAW, kind \& gezin, etc.) and can voluntarily register for the project. When a family is registered, they receive a recipe booklet every two weeks at home. The booklet consists of six easy, child-friendly recipes with accompanying shopping lists. Recipes are targeted at three people and include fish, meat and veggie dishes. Each recipe is guaranteed to cost no more than one, two or three euros per serving. The participants are registered via the Xtra-card (loyalty card of Colruyt), so that the discount can be offered anonymously and discretely. Since the intervention is an already existing one, we made an overview of the intervention components, behavior change techniques and practical applications, based on the Intervention Mapping Theory (Kok et al., 2015) and the Behavior Change Wheel (Abraham \& Michie, 2008). Based on this overview, we determined goals and outcome measures for our research project.
In the qualitative study (WP1), participants of the intervention, as well as representatives of social organizations will be recruited to participate in an interview and/or focus group interview. Interviews will be conducted until data saturation is reached.
In the interventional study (WP3), participants of the project (intervention condition) will be compared to participants in a control condition who do not participate in the project. A total sample size of 200 participants is calculated, based on an a priori power analysis (two groups, two measurements, α=0.05; power=0.80, ES=0.25). Participants in both conditions will complete a survey in a pre-measurement and a post-measurement, three months after the start of the intervention.
The second effect study (WP2) has a longitudinal pre-post design, and is based on secondary purchase data from 2018 until 2022. The intervention group (i.e., participants of the intervention) will be compared to a control group (i.e., not subscribed in the intervention), by using general customer data. A multilevel growth model will be used to look at each individual's different purchase moments, with data before and during the intervention. The model represents three levels: 1) point of time/purchase, 2) customer, 3) store/location.
- Conditions
- Consumer Behavior, Food Selection
- Being tested
- The intervention "Aan Tafel in 1, 2, 3 euro"
- Keywords
- Health promotion, Nutrition intervention, Socioeconomic status, Family meals, Parents
- Medical subject headings
- Consumer Behavior, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention "Aan Tafel in 1, 2, 3 euro"Behavioural
The participants in this group are clients of Colruyt who are subscribed to the program "Aan Tafel in 1 2 3 euro". They will receive two-weekly recipe booklets with 6 balanced and child-friendly recipes in each booklet. They are guaranteed a fixed price for each recipe, that will be given at the checkout counter, based on their loyalty card.
| Study group | Role | What they receive |
|---|---|---|
| The intervention "Aan Tafel in 1, 2, 3 euro" | Experimental | The participants use the intervention program: the recipe booklets and the provided price guarantee for their meals. Receives: Behavioral: The intervention "Aan Tafel in 1, 2, 3 euro" |
| Control group | No intervention | The participants are not registered to use the program and will be recruited in social organizations to match their sociodemographic profile as much as possible. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Food literacy
Food Literacy will be assessed via the 11 item questionnaire of Begley et al. (2018). And via the 6-item subscale 'Food preparation skills' of the Self-Perceived Food Literacy (SPFL) scale of Poelman et al. (2018).
Measured: Change from baseline food literacy at 3 months
Change in Self-efficacy for eating/cooking vegetables and fruits
Self-efficacy will be measured with the 4-item subscale of the survey of Condrasky et al. (2011) 3. Food security, measured with the questionnaire of Gulliford et al. (2006)
Measured: Change from baseline self-efficacy at 3 months
Change in Cooking attitude
Cooking attitudes will be measured with the 4-item subscale of the survey of Condrasky et al. (2011)
Measured: Change from baseline attitudes at 3 months
Change in Food security
Food security will be assessed via the 18 Household Food Security Survey (HFSS) items of Gulliford et al. (2006)
Measured: Change from baseline food security at 3 months
Change in Family meal time frequency
Family meal time frequency will be measured with an item out of the questionnaire of "Family meal time environment" of Fulkerson et al. (2006)
Measured: Change from baseline meal time frequency at 3 months
Change in Meal preparation
Meal preparation will be measured with an item out of the short questionnaire for assessing the impact of cooking skills interventions by Barton et al. (2011).
Measured: Change from baseline meal preparation at 3 months
Change in food purchases (WP2)
Food categories such as vegetables, ready-to-eat meals and snacks
Measured: Change from amount of food purchases before the subscription into the project at the time after subscription
Secondary outcomes (1)
Change in Reported eating behavior
Specific food items related to mealtime are measured, based on the Health Behavior in School-aged Children (HBSC) survey.
Measured: Change from baseline reported eating behavior at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Nov 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Consumer BehaviorStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Van Lippevelde, Study director, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595551
- Sponsor's protocol ID
- ONZ-2022-0343
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2022
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kok G, Gottlieb NH, Peters GJ, Mullen PD, Parcel GS, Ruiter RA, Fernandez ME, Markham C, Bartholomew LK. A taxonomy of behaviour change methods: an Intervention Mapping approach. Health Psychol Rev. 2016 Sep;10(3):297-312. doi: 10.1080/17437199.2015.1077155. Epub 2015 Oct 15.
PubMed 26262912Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol. 2008 May;27(3):379-87. doi: 10.1037/0278-6133.27.3.379.
PubMed 18624603Barton KL, Wrieden WL, Anderson AS. Validity and reliability of a short questionnaire for assessing the impact of cooking skills interventions. J Hum Nutr Diet. 2011 Dec;24(6):588-95. doi: 10.1111/j.1365-277X.2011.01180.x. Epub 2011 Jun 8.
PubMed 21649746Fulkerson JA, Neumark-Sztainer D, Story M. Adolescent and parent views of family meals. J Am Diet Assoc. 2006 Apr;106(4):526-32. doi: 10.1016/j.jada.2006.01.006.
PubMed 16567147Begley A, Paynter E, Dhaliwal SS. Evaluation Tool Development for Food Literacy Programs. Nutrients. 2018 Nov 2;10(11):1617. doi: 10.3390/nu10111617.
PubMed 30400130Poelman MP, Dijkstra SC, Sponselee H, Kamphuis CBM, Battjes-Fries MCE, Gillebaart M, Seidell JC. Towards the measurement of food literacy with respect to healthy eating: the development and validation of the self perceived food literacy scale among an adult sample in the Netherlands. Int J Behav Nutr Phys Act. 2018 Jun 18;15(1):54. doi: 10.1186/s12966-018-0687-z.
PubMed 29914503Condrasky MD, Williams JE, Catalano PM, Griffin SF. Development of psychosocial scales for evaluating the impact of a culinary nutrition education program on cooking and healthful eating. J Nutr Educ Behav. 2011 Nov-Dec;43(6):511-6. doi: 10.1016/j.jneb.2010.09.013. Epub 2011 Aug 15.
PubMed 21840764Gulliford MC, Nunes C, Rocke B. The 18 Household Food Security Survey items provide valid food security classifications for adults and children in the Caribbean. BMC Public Health. 2006 Feb 8;6:26. doi: 10.1186/1471-2458-6-26.
PubMed 16466571Vos M, Proesmans VLJ, Van Kerckhove A, Deforche B, Michels N, Poelman MP, Van Lippevelde W. Evaluation of a national supermarket intervention supporting vulnerable families in healthy meal practices: a natural experiment. BMC Med. 2025 Jul 1;23(1):382. doi: 10.1186/s12916-025-04210-y.
PubMed 40597156Vos M, Van Kerckhove A, Deforche B, Proesmans VLJ, Michels N, Poelman MP, Geuens M, Van Lippevelde W. Supporting vulnerable families' meal practices: process evaluation of a nationwide intervention implemented by a retailer and social organizations. BMC Public Health. 2024 Nov 6;24(1):3060. doi: 10.1186/s12889-024-20488-8.
PubMed 39506698
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Healthy and Sustainable Family Meals Among Parents With Lower Socioeconomic Status: Process and Effect Evaluation of the Project "Aan Tafel in 1,2,3 Euro"
- ClinicalTrials.gov ID
- NCT05595551
- Acronym / sponsor ID
- ONZ-2022-0343
- Conditions
- Consumer Behavior, Food Selection
- Keywords
- Health promotion, Nutrition intervention, Socioeconomic status, Family meals, Parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 27 Oct 2022 (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 research project is to learn what the impact of the specific project "Aan Tafel in 1 2 3 euro" is on the food and meal habits of families of lower SES.
Three types of studies will be conducted:
WP1) Process evaluation via qualitative research: focus groups and/or individual interviews with participants of Aan Tafel in 1 2 3 euro, and with delegates of the social organizations;
WP2) Effect evaluation via secondary data-analysis of purchase data retrieved from loyalty cards of participants, and of general customers (i.e., control group);
WP3) Process and effect evaluation with a control group in a baseline-post design: the intervention group are participants of the program, and the control group are clients in social organizations, but do not participate in the program.
On the one hand we want to find out if the intervention has an effect on specific determinants (i.e., food literacy, self-efficacy, attitudes, food security) of food behavior/meal prepping behavior and on meal structure of the family (i.e., amount of freshly made meals, amount of meals cooked and consumed together) (WP3), as well as on participants' food choices (WP2). On the other hand we want to find out how participans experience the program, what succes factors and barriers are, as well as how social organizations experience the program (as a partner of Colruyt, and contact person of the vulnerable families) (WP1).
Detailed description
"Aan Tafel in 1 2 3 euro" is a project of retailer Colruyt in cooperation with social organizations in Belgium. The project/intervention was launched in 2016 and has been implemented throughout Belgium since. In 2021 about 8000 families have already been subscribed, and the numbers are still growing. Families with a lower SES (vulnerable families) are informed by a social organization (OCMW, CAW, kind \& gezin, etc.) and can voluntarily register for the project. When a family is registered, they receive a recipe booklet every two weeks at home. The booklet consists of six easy, child-friendly recipes with accompanying shopping lists. Recipes are targeted at three people and include fish, meat and veggie dishes. Each recipe is guaranteed to cost no more than one, two or three euros per serving. The participants are registered via the Xtra-card (loyalty card of Colruyt), so that the discount can be offered anonymously and discretely. Since the intervention is an already existing one, we made an overview of the intervention components, behavior change techniques and practical applications, based on the Intervention Mapping Theory (Kok et al., 2015) and the Behavior Change Wheel (Abraham \& Michie, 2008). Based on this overview, we determined goals and outcome measures for our research project.
In the qualitative study (WP1), participants of the intervention, as well as representatives of social organizations will be recruited to participate in an interview and/or focus group interview. Interviews will be conducted until data saturation is reached.
In the interventional study (WP3), participants of the project (intervention condition) will be compared to participants in a control condition who do not participate in the project. A total sample size of 200 participants is calculated, based on an a priori power analysis (two groups, two measurements, α=0.05; power=0.80, ES=0.25). Participants in both conditions will complete a survey in a pre-measurement and a post-measurement, three months after the start of the intervention.
The second effect study (WP2) has a longitudinal pre-post design, and is based on secondary purchase data from 2018 until 2022. The intervention group (i.e., participants of the intervention) will be compared to a control group (i.e., not subscribed in the intervention), by using general customer data. A multilevel growth model will be used to look at each individual's different purchase moments, with data before and during the intervention. The model represents three levels: 1) point of time/purchase, 2) customer, 3) store/location.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention "Aan Tafel in 1, 2, 3 euro" | Experimental | Behavioral: The intervention "Aan Tafel in 1, 2, 3 euro"The participants use the intervention program: the recipe booklets and the provided price guarantee for their meals. |
| Control group | No intervention | –The participants are not registered to use the program and will be recruited in social organizations to match their sociodemographic profile as much as possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be registered for the project Aan Tafel in 1-2-3 euro
- Be a member of a family with at least one child under the age of 18 living at home.
- Being Dutch-speaking: thorough knowledge of Dutch in terms of reading/writing/speaking.
- Be over 18 years old and (regularly) responsible for the preparation of the family meals
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The intervention "Aan Tafel in 1, 2, 3 euro"The participants in this group are clients of Colruyt who are subscribed to the program "Aan Tafel in 1 2 3 euro". They will receive two-weekly recipe booklets with 6 balanced and child-friendly recipes in each booklet. They are guaranteed a fixed price for each recipe, that will be given at the checkout counter, based on their loyalty card. | Behavioural | The intervention "Aan Tafel in 1, 2, 3 euro" |
Primary outcome
Change in Food literacy
Time frame: Change from baseline food literacy at 3 months
Food Literacy will be assessed via the 11 item questionnaire of Begley et al. (2018). And via the 6-item subscale 'Food preparation skills' of the Self-Perceived Food Literacy (SPFL) scale of Poelman et al. (2018).
Change in Self-efficacy for eating/cooking vegetables and fruits
Time frame: Change from baseline self-efficacy at 3 months
Self-efficacy will be measured with the 4-item subscale of the survey of Condrasky et al. (2011) 3. Food security, measured with the questionnaire of Gulliford et al. (2006)
Change in Cooking attitude
Time frame: Change from baseline attitudes at 3 months
Cooking attitudes will be measured with the 4-item subscale of the survey of Condrasky et al. (2011)
Change in Food security
Time frame: Change from baseline food security at 3 months
Food security will be assessed via the 18 Household Food Security Survey (HFSS) items of Gulliford et al. (2006)
Change in Family meal time frequency
Time frame: Change from baseline meal time frequency at 3 months
Family meal time frequency will be measured with an item out of the questionnaire of "Family meal time environment" of Fulkerson et al. (2006)
Change in Meal preparation
Time frame: Change from baseline meal preparation at 3 months
Meal preparation will be measured with an item out of the short questionnaire for assessing the impact of cooking skills interventions by Barton et al. (2011).
Change in food purchases (WP2)
Time frame: Change from amount of food purchases before the subscription into the project at the time after subscription
Food categories such as vegetables, ready-to-eat meals and snacks
1 secondary outcome
Change in Reported eating behavior
Time frame: Change from baseline reported eating behavior at 3 months
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 6 Oct 2023.
- Background: PubMed 26262912Kok G, Gottlieb NH, Peters GJ, Mullen PD, Parcel GS, Ruiter RA, Fernandez ME, Markham C, Bartholomew LK. A taxonomy of behaviour change methods: an Intervention Mapping approach. Health Psychol Rev. 2016 Sep;10(3):297-312. doi: 10.1080/17437199.2015.1077155. Epub 2015 Oct 15.
- Background: PubMed 18624603Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol. 2008 May;27(3):379-87. doi: 10.1037/0278-6133.27.3.379.
- Background: PubMed 21649746Barton KL, Wrieden WL, Anderson AS. Validity and reliability of a short questionnaire for assessing the impact of cooking skills interventions. J Hum Nutr Diet. 2011 Dec;24(6):588-95. doi: 10.1111/j.1365-277X.2011.01180.x. Epub 2011 Jun 8.
- Background: PubMed 16567147Fulkerson JA, Neumark-Sztainer D, Story M. Adolescent and parent views of family meals. J Am Diet Assoc. 2006 Apr;106(4):526-32. doi: 10.1016/j.jada.2006.01.006.
- Background: PubMed 30400130Begley A, Paynter E, Dhaliwal SS. Evaluation Tool Development for Food Literacy Programs. Nutrients. 2018 Nov 2;10(11):1617. doi: 10.3390/nu10111617.
- Background: PubMed 29914503Poelman MP, Dijkstra SC, Sponselee H, Kamphuis CBM, Battjes-Fries MCE, Gillebaart M, Seidell JC. Towards the measurement of food literacy with respect to healthy eating: the development and validation of the self perceived food literacy scale among an adult sample in the Netherlands. Int J Behav Nutr Phys Act. 2018 Jun 18;15(1):54. doi: 10.1186/s12966-018-0687-z.
- Background: PubMed 21840764Condrasky MD, Williams JE, Catalano PM, Griffin SF. Development of psychosocial scales for evaluating the impact of a culinary nutrition education program on cooking and healthful eating. J Nutr Educ Behav. 2011 Nov-Dec;43(6):511-6. doi: 10.1016/j.jneb.2010.09.013. Epub 2011 Aug 15.
- Background: PubMed 16466571Gulliford MC, Nunes C, Rocke B. The 18 Household Food Security Survey items provide valid food security classifications for adults and children in the Caribbean. BMC Public Health. 2006 Feb 8;6:26. doi: 10.1186/1471-2458-6-26.
- Derived from this study: PubMed 40597156Vos M, Proesmans VLJ, Van Kerckhove A, Deforche B, Michels N, Poelman MP, Van Lippevelde W. Evaluation of a national supermarket intervention supporting vulnerable families in healthy meal practices: a natural experiment. BMC Med. 2025 Jul 1;23(1):382. doi: 10.1186/s12916-025-04210-y.
- Derived from this study: PubMed 39506698Vos M, Van Kerckhove A, Deforche B, Proesmans VLJ, Michels N, Poelman MP, Geuens M, Van Lippevelde W. Supporting vulnerable families' meal practices: process evaluation of a nationwide intervention implemented by a retailer and social organizations. BMC Public Health. 2024 Nov 6;24(1):3060. doi: 10.1186/s12889-024-20488-8.
- 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.
Wendy Van Lippevelde study director
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention "Aan Tafel in 1, 2, 3 euro" in people with Consumer Behavior and Food Selection, run by University Ghent at 1 site in Belgium.
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 4 inclusion and 0 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 6 Oct 2023. 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 Belgium. 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?
Change in Food literacy (time frame: Change from baseline food literacy at 3 months). The study lists 7 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 NCT05595551, which also lists 10 linked publications.
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 6 Oct 2023.