Knowledge, Attitudes, PracticeDaireNCT04277312
Project Daire: Derry/Londonderry as the Nexus City for Food, Education, Trust and Health
A study testing Engage and Nourish in people with Knowledge, Attitudes, Practice, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
Project Daire is a randomised-controlled factorial design trial working in partnership with primary schools and local food producers evaluating two interventions designed to improve primary school children's knowledge of and interest in food and where it comes from, with the ultimate aim of driving improvement in… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice
- What is being tested?
- Engage and Nourish
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2019to 27 Jun 2019
- 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mainstream primary schools willing to be randomly assigned to an intervention,
- Mainstream primary schools willing to engage with the intervention and implement it with their pupils,
- Mainstream primary schools willing to facilitate pre and post-test data collection in their setting,
- Mainstream primary schools within the North West region of Northern Ireland.
- Pupils in Primary 3 (Key Stage 1) and Primary 7 (Key Stage 2) of participating schools were eligible to take part.
Who cannot join
- Secondary schools
- Non-mainstream schools
- Schools not in the North West region of Northern Ireland
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Public Health, Queen's University Belfast
Belfast, Northern Ireland, BT12 6BJ
About this study
Official title: Project Daire: Derry/Londonderry as the Nexus City for Food, Education, Trust and Health'
Project Daire is a randomised-controlled factorial design trial working in partnership with primary schools and local food producers evaluating two interventions designed to improve primary school children's knowledge of and interest in food and where it comes from, with the ultimate aim of driving improvement in health, well-being and educational status.
Read the detailed description
Project Daire is a randomised-controlled factorial design trial working in partnership with primary schools and local food producers evaluating two interventions designed to improve primary school children's knowledge of and interest in food and where it comes from, with the ultimate aim of driving improvement in health, well-being and educational status. Key Stage 1 and 2 pupils will be recruited from 15 primary schools in the North West of Northern Ireland and will be randomised to one of four intervention arms: i) 'Engage', ii) 'Nourish', iii) 'Engage' and 'Nourish' and iv) Delayed of duration up to 6 months. Study outcomes include food knowledge, attitudes, trust, diet, behaviour, health and wellbeing and will be collected at baseline and six months.
- Conditions
- Knowledge, Attitudes, Practice
- Being tested
- Engage, Nourish
- Keywords
- Primary School Children, Food Education, Food Knowledge, Childhood Health, Childhood Wellbeing
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EngageBehavioural
The Engage intervention was developed with input from primary school teachers and includes a range of age-appropriate educational activities related to food. Activities include videos, lesson plans, worksheets, games, talks/visits from experts, visits to industrial partners and other local food-related centres of interest and practical activities such as experiments. All 'Engage' material is mapped to the Northern Ireland School Curriculum. The 'Engage' intervention is structured into three broad topics: Farm to Fork; Pleasure on a Plate and Food Futures. Engage resources were provided to schools electronically and in hard copy and teachers delivered most of the content, with the exception of several sessions which were delivered by visiting scientists.
NourishBehavioural
The Nourish intervention is a school food environment intervention which included weekly healthy snack provision supplied by food industry partners, enhancement of canteen dining area (café style, tablecloths, centre pieces, bunting and menu boards, healthy eating posters), attendance at Tasting Days held in Higher Education Colleges (children were encouraged to try new foods provided by industry partners and received stamps on 'food passports' in return) and sensory educational and cookery activities.
| Study group | Role | What they receive |
|---|---|---|
| Engage | Experimental | The Engage intervention was developed with input from primary school teachers and includes a range of age-appropriate educational activities related to food. Activities include videos, lesson plans, worksheets, games, talks/visits from experts, visits to industrial partners and other local food-related centres of interest and practical activities such as experiments. All 'Engage' material is mapped to the Northern Ireland School Curriculum. The 'Engage' intervention is structured into three broad topics: Farm to Fork; Pleasure on a Plate and Food Futures. Engage resources were provided to schools electronically and in hard copy and teachers delivered most of the content, with the exception of several sessions which were delivered by visiting scientists. Receives: Behavioral: Engage |
| Nourish | Experimental | The Nourish intervention is a school food environment intervention which included weekly healthy snack provision supplied by food industry partners, enhancement of canteen dining area (café style, tablecloths, centre pieces, bunting and menu boards, healthy eating posters), attendance at Tasting Days held in Higher Education Colleges (children were encouraged to try new foods provided by industry partners and received stamps on 'food passports' in return) and sensory educational and cookery activities. Receives: Behavioral: Nourish |
| Nourish and Engage | Experimental | This arm of the intervention delivered both the Nourish and Engage interventions as detailed above. Receives: Behavioral: Engage; Behavioral: Nourish |
| Delayed | No intervention | The delayed arm of the intervention was the control arm. Schools randomised to this arm of the study were offered the Engage intervention resources after endpoint data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KIDSCREEN-10 score at 6 months
Validated well-being questionnaire for children. Completed by KS1 and KS2 pupils.This is an 11-item instrument answered on a 5-point scale and results in one global HRQoL score. Most of the items are formulated positively and in concordance with the scoring, which means a higher score reflects a higher HRQoL. However, some items are formulated negatively and as a consequence the scoring has to be recoded. The scoring method results in T-values with scale means around 50 and standard deviations around 10 with higher values indicating higher HRQoL.
Measured: Baseline (Month 0), 6 months
Change in Strengths and Difficulties Questionnaire score at 6 months
Validated brief behavioural screening questionnaire. Completed by teachers. This 25-item instrument incorporates 5 scales of 5 items, with each item answered on a 3 point scale. All scales represent a negative trait, with the exception of the ProSocial Scale which indicates a positive trait. For each of the 5 scales the score can range from 0 to 10 if all items were completed. A Total Difficulties score is the final score and indicates poorer behaviour. Therefore the lower the score, the better the outcome in terms of behaviour.
Measured: Baseline (Month 0), 6 months
Secondary outcomes (15)
24 Hour Dietary Record
Validated dietary intake questionnaire in age group (Moore et al., Br J Nutr 2008;99:1266-74). Completed by KS1 and KS2 pupils. Prospective record of all foods and drinks consumed over a 24 hour period. Data are analysed using dietary analysis software to produce average daily intake of food groups, macronutrients, micronutrients, vitamins and minerals.
Measured: Baseline (Month 0), 6 months
Food Frequency Questionnaire
Food Frequency Questionnaire developed by study team based on other similar age-appropriate food frequency questionnaires (Cade et al., Public Health Nutr 2005;9:501-8). Two versions-one shorter version developed for younger KS1 age group, one for KS2 age group. Children asked to indicate categorical responses ('yes', 'no' and 'not sure') to indicate whether or not they ever eat a particular food. Presented as a food group list with categorical responses.
Measured: Baseline (Month 0), 6 months
Food Shopping, Preparation & Consumption
Questionnaire developed by study team. Completed by KS1 and KS2 pupils. Children asked to indicate categorical responses 'always', 'sometimes', 'never' or 'agree' 'not sure' or 'do not agree' with reference to various cooking, food preparation scenarios and how they feel about trying new foods.
Measured: Baseline (Month 0), 6 months
Perceived cooking competence
Researcher developed questionnaire (items sourced from unpublished data), based on similar measures for perceived movement competence (Barnett et al., 2015; Harter and Pike, 1984). Completed by KS1 and KS2 pupils-shorter version developed for KS2 pupils. Categorical responses 'yes' and 'no' with regards to have they ever demonstrated a range of different cooking skills. Children are then presented with a range of illustrated characters who vary in their competence and child indicates which child they are most like with regards to that particular cooking skill.
Measured: Baseline (Month 0), 6 months
Agri-Food Knowledge
Questionnaire designed to assess pupil knowledge on range of agri-food topics (food chain, farm, seasonality, local versus imported). Researcher developed with industry input, piloted and face validity with experts in the different fields, some items adapted from previous measures (Moss et al., 2013; Reynolds et al., 2012; Harmon and Maretzki, 2006; Saksvig et al., 2005) and BNF - Food a fact of Life (http://archive.foodafactoflife.org.uk/Activity.aspx?siteId=14\§ionId=63\&contentId=176). Completed by KS1 and KS2 pupils-shorter version developed for KS1 pupils. Responses categorical and categories varied by item type.
Measured: Baseline (Month 0), 6 months
Food Jobs/Careers Aspirations
Questionnaire to assess career aspirations and knowledge of food-related jobs. Developed by research team. Completed by KS1 and KS2 pupils. Open-ended questions asking about career aspirations and assessing knowledge of careers related to food.
Measured: Baseline (Month 0), 6 months
Preference/Willingness to Try
Questionnaire to assess knowledge of willingness to try range of foods. Researcher adapted from Morgan et al. (2010) and Birch and Sullivan (1991). Completed by KS1 and KS2 pupils-shorter version for KS1 pupils.Responses largely categorical with some open-ended questions asking children to identify the food.
Measured: Baseline (Month 0), 6 months
Attitudes
Questionnaire to assess pupil attitude to importance of health behaviours, including diet. Previously used in a survey of NI schoolchildren health (Young Hearts Studies). Completed by KS2 pupils only. This is an 11-item instrument assessing attitudes towards importance of various health behaviours 'very important', 'quite important', 'not important'
Measured: Baseline (Month 0), 6 months
Food source to product - knowledge
Questionnaire to assess level of knowledge in terms of food source to product. Developed by research team. Completed by KS1 and KS2 pupils. Categorical matching responses.
Measured: Baseline (Month 0), 6 months
Trust
Questionnaire to assess level of trust in local food products. Developed by research team. Completed by KS2 only. This is a 10-item instrument answered on a 5-point scale (definitely disagree, disagree, not sure, agree, definitely agree).
Measured: Baseline (Month 0), 6 months
School food environment observation
Observational proforma designed to allow researcher to assess current school food environment. Developed by research team. Completed by researcher. Observational-open-ended responses.
Measured: Baseline (Month 0), 6 months
School food environment questionnaire
Questionnaire designed to assess current school food environment. Developed by research team. Completed by school principal/management
Measured: Baseline (Month 0), 6 months
Exposure to/Experience with Agri-Food
Questionnaire designed to characterise pupils in terms of previous experience of agri-food. Developed by research team. Developed with KS1 and KS2 age-appropriate questions. Categorical responses.
Measured: Baseline only (Month 0)
Baseline Skills Scale
Questionnaire designed to characterise pupil's level of cooking skills. Previously validated questionnaire. Children indicate how good they believe they are at various cooking skills on a 7-point scale (1 is very poor and 7 is very good).
Measured: Baseline only (Month 0)
Daire Evaluation questionnaire
Process Evaluation questionnaire for both Nourish and Engage interventions completed by teachers. Developed by research team. Categorical and op-ended responses.
Measured: 6 months only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start7 Jan 2019
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Project Daire is a randomised-controlled, factorial design trial evaluating two interventions
- Masking
- None (open label)
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Invest NI
- Responsible party
- Principal investigator, Jayne Woodside, PhD, Queen's University, Belfast
- Investigators
- Jayne Woodside, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277312
- Sponsor's protocol ID
- 038_1819
- Other IDs
- RD1014267
- Acronym
- Daire
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olgacher D, Wallace C, Brennan SF, Lavelle F, Moore SE, McKinley MC, McCole P, Hunter RF, Dunne L, Cardwell CR, McCarthy D, Woodside JV. Primary school-based food environment intervention increases diet diversity: Project Daire, a cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2025 Nov 21;22(1):149. doi: 10.1186/s12966-025-01842-4.
PubMed 41272727Anderson N, Brennan SF, Lavelle F, Moore SE, Olgacher D, Junkin A, Dean M, McKinley MC, McCole P, Hunter RF, Dunne L, O'Connell NE, Elliott CT, McCarthy D, Woodside JV. Process evaluation of Project Daire: a food environment intervention that impacted food knowledge, wellbeing and dietary habits of primary school children. BMC Public Health. 2025 Feb 6;25(1):486. doi: 10.1186/s12889-025-21628-4.
PubMed 39910503Brennan SF, Lavelle F, Moore SE, Dean M, McKinley MC, McCole P, Hunter RF, Dunne L, O'Connell NE, Cardwell CR, Elliott CT, McCarthy D, Woodside JV. Food environment intervention improves food knowledge, wellbeing and dietary habits in primary school children: Project Daire, a randomised-controlled, factorial design cluster trial. Int J Behav Nutr Phys Act. 2021 Feb 4;18(1):23. doi: 10.1186/s12966-021-01086-y.
PubMed 33541372
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Daire: Derry/Londonderry as the Nexus City for Food, Education, Trust and Health'
- ClinicalTrials.gov ID
- NCT04277312
- Acronym / sponsor ID
- Daire / 038_1819
- Conditions
- Knowledge, Attitudes, Practice
- Keywords
- Primary School Children, Food Education, Food Knowledge, Childhood Health, Childhood Wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Invest NI
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 20 Feb 2020 (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.
Project Daire is a randomised-controlled factorial design trial working in partnership with primary schools and local food producers evaluating two interventions designed to improve primary school children's knowledge of and interest in food and where it comes from, with the ultimate aim of driving improvement in health, well-being and educational status.
Detailed description
Project Daire is a randomised-controlled factorial design trial working in partnership with primary schools and local food producers evaluating two interventions designed to improve primary school children's knowledge of and interest in food and where it comes from, with the ultimate aim of driving improvement in health, well-being and educational status. Key Stage 1 and 2 pupils will be recruited from 15 primary schools in the North West of Northern Ireland and will be randomised to one of four intervention arms: i) 'Engage', ii) 'Nourish', iii) 'Engage' and 'Nourish' and iv) Delayed of duration up to 6 months. Study outcomes include food knowledge, attitudes, trust, diet, behaviour, health and wellbeing and will be collected at baseline and six months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Project Daire is a randomised-controlled, factorial design trial evaluating two interventions
| Arm | Type | Receives |
|---|---|---|
| Engage | Experimental | Behavioral: EngageThe Engage intervention was developed with input from primary school teachers and includes a range of age-appropriate educational activities related to food. Activities include videos, lesson plans, worksheets, games, talks/visits from experts, visits to industrial partners and other local food-related centres of interest and practical activities such as experiments. All 'Engage' material is mapped to the Northern Ireland School Curriculum. The 'Engage' intervention is structured into three broad topics: Farm to Fork; Pleasure on a Plate and Food Futures. Engage resources were provided to schools electronically and in hard copy and teachers delivered most of the content, with the exception of several sessions which were delivered by visiting scientists. |
| Nourish | Experimental | Behavioral: NourishThe Nourish intervention is a school food environment intervention which included weekly healthy snack provision supplied by food industry partners, enhancement of canteen dining area (café style, tablecloths, centre pieces, bunting and menu boards, healthy eating posters), attendance at Tasting Days held in Higher Education Colleges (children were encouraged to try new foods provided by industry partners and received stamps on 'food passports' in return) and sensory educational and cookery activities. |
| Nourish and Engage | Experimental | Behavioral: Engage, Behavioral: NourishThis arm of the intervention delivered both the Nourish and Engage interventions as detailed above. |
| Delayed | No intervention | –The delayed arm of the intervention was the control arm. Schools randomised to this arm of the study were offered the Engage intervention resources after endpoint data collection. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Mainstream primary schools willing to be randomly assigned to an intervention,
- Mainstream primary schools willing to engage with the intervention and implement it with their pupils,
- Mainstream primary schools willing to facilitate pre and post-test data collection in their setting,
- Mainstream primary schools within the North West region of Northern Ireland.
- Pupils in Primary 3 (Key Stage 1) and Primary 7 (Key Stage 2) of participating schools were eligible to take part.
Key exclusion criteria (3 listed)
- Secondary schools
- Non-mainstream schools
- Schools not in the North West region of Northern Ireland
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 |
|---|---|---|
| EngageThe Engage intervention was developed with input from primary school teachers and includes a range of age-appropriate educational activities related to food. Activities include videos, lesson plans, worksheets, games, talks/visits from experts, visits to industrial partners and other local food-related centres of interest and practical activities such as experiments. All 'Engage' material is mapped to the Northern Ireland School Curriculum. The 'Engage' intervention is structured into three broad topics: Farm to Fork; Pleasure on a Plate and Food Futures. Engage resources were provided to schools electronically and in hard copy and teachers delivered most of the content, with the exception of several sessions which were delivered by visiting scientists. | Behavioural | Engage, Nourish and Engage |
| NourishThe Nourish intervention is a school food environment intervention which included weekly healthy snack provision supplied by food industry partners, enhancement of canteen dining area (café style, tablecloths, centre pieces, bunting and menu boards, healthy eating posters), attendance at Tasting Days held in Higher Education Colleges (children were encouraged to try new foods provided by industry partners and received stamps on 'food passports' in return) and sensory educational and cookery activities. | Behavioural | Nourish, Nourish and Engage |
Primary outcome
Change in KIDSCREEN-10 score at 6 months
Time frame: Baseline (Month 0), 6 months
Validated well-being questionnaire for children. Completed by KS1 and KS2 pupils.This is an 11-item instrument answered on a 5-point scale and results in one global HRQoL score. Most of the items are formulated positively and in concordance with the scoring, which means a higher score reflects a higher HRQoL. However, some items are formulated negatively and as a consequence the scoring has to be recoded. The scoring method results in T-values with scale means around 50 and standard deviations around 10 with higher values indicating higher HRQoL.
Change in Strengths and Difficulties Questionnaire score at 6 months
Time frame: Baseline (Month 0), 6 months
Validated brief behavioural screening questionnaire. Completed by teachers. This 25-item instrument incorporates 5 scales of 5 items, with each item answered on a 3 point scale. All scales represent a negative trait, with the exception of the ProSocial Scale which indicates a positive trait. For each of the 5 scales the score can range from 0 to 10 if all items were completed. A Total Difficulties score is the final score and indicates poorer behaviour. Therefore the lower the score, the better the outcome in terms of behaviour.
15 secondary outcomes
24 Hour Dietary Record
Time frame: Baseline (Month 0), 6 months
Food Frequency Questionnaire
Time frame: Baseline (Month 0), 6 months
Food Shopping, Preparation & Consumption
Time frame: Baseline (Month 0), 6 months
Perceived cooking competence
Time frame: Baseline (Month 0), 6 months
Agri-Food Knowledge
Time frame: Baseline (Month 0), 6 months
Food Jobs/Careers Aspirations
Time frame: Baseline (Month 0), 6 months
Preference/Willingness to Try
Time frame: Baseline (Month 0), 6 months
Attitudes
Time frame: Baseline (Month 0), 6 months
Food source to product - knowledge
Time frame: Baseline (Month 0), 6 months
Trust
Time frame: Baseline (Month 0), 6 months
School food environment observation
Time frame: Baseline (Month 0), 6 months
School food environment questionnaire
Time frame: Baseline (Month 0), 6 months
Exposure to/Experience with Agri-Food
Time frame: Baseline only (Month 0)
Baseline Skills Scale
Time frame: Baseline only (Month 0)
Daire Evaluation questionnaire
Time frame: 6 months only
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 20 Feb 2020.
- Derived from this study: PubMed 41272727Olgacher D, Wallace C, Brennan SF, Lavelle F, Moore SE, McKinley MC, McCole P, Hunter RF, Dunne L, Cardwell CR, McCarthy D, Woodside JV. Primary school-based food environment intervention increases diet diversity: Project Daire, a cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2025 Nov 21;22(1):149. doi: 10.1186/s12966-025-01842-4.
- Derived from this study: PubMed 39910503Anderson N, Brennan SF, Lavelle F, Moore SE, Olgacher D, Junkin A, Dean M, McKinley MC, McCole P, Hunter RF, Dunne L, O'Connell NE, Elliott CT, McCarthy D, Woodside JV. Process evaluation of Project Daire: a food environment intervention that impacted food knowledge, wellbeing and dietary habits of primary school children. BMC Public Health. 2025 Feb 6;25(1):486. doi: 10.1186/s12889-025-21628-4.
- Derived from this study: PubMed 33541372Brennan SF, Lavelle F, Moore SE, Dean M, McKinley MC, McCole P, Hunter RF, Dunne L, O'Connell NE, Cardwell CR, Elliott CT, McCarthy D, Woodside JV. Food environment intervention improves food knowledge, wellbeing and dietary habits in primary school children: Project Daire, a randomised-controlled, factorial design cluster trial. Int J Behav Nutr Phys Act. 2021 Feb 4;18(1):23. doi: 10.1186/s12966-021-01086-y.
- 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.
Jayne Woodside, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engage and Nourish in people with Knowledge, Attitudes, Practice, run by Queen's University, Belfast at 1 site in United Kingdom.
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 5 inclusion and 3 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 20 Feb 2020. 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 United Kingdom. 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 KIDSCREEN-10 score at 6 months (time frame: Baseline (Month 0), 6 months). The study lists 2 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 NCT04277312, which also lists 3 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 20 Feb 2020.