- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04277312
Project Daire: Derry/Londonderry as the Nexus City for Food, Education, Trust and Health (Daire)
17 febbraio 2020 aggiornato da: Jayne Woodside, PhD, Queen's University, Belfast
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1080
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Northern Ireland
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Belfast, Northern Ireland, Regno Unito, BT12 6BJ
- Centre for Public Health, Queen's University Belfast
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 6 anni a 11 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- 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.
Exclusion criteria
- Secondary schools
- Non-mainstream schools
- Schools not in the North West region of Northern Ireland
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Engage
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.
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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.
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|
Sperimentale: Nourish
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.
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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.
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Sperimentale: Nourish and Engage
This arm of the intervention delivered both the Nourish and Engage interventions as detailed above.
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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.
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.
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Nessun intervento: Delayed
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in KIDSCREEN-10 score at 6 months
Lasso di tempo: Baseline (Month 0), 6 months
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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.
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Baseline (Month 0), 6 months
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Change in Strengths and Difficulties Questionnaire score at 6 months
Lasso di tempo: Baseline (Month 0), 6 months
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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.
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Baseline (Month 0), 6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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24 Hour Dietary Record
Lasso di tempo: Baseline (Month 0), 6 months
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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.
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Baseline (Month 0), 6 months
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Food Frequency Questionnaire
Lasso di tempo: Baseline (Month 0), 6 months
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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.
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Baseline (Month 0), 6 months
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Food Shopping, Preparation & Consumption
Lasso di tempo: Baseline (Month 0), 6 months
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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.
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Baseline (Month 0), 6 months
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Perceived cooking competence
Lasso di tempo: Baseline (Month 0), 6 months
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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.
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Baseline (Month 0), 6 months
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Agri-Food Knowledge
Lasso di tempo: Baseline (Month 0), 6 months
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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.
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Baseline (Month 0), 6 months
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Food Jobs/Careers Aspirations
Lasso di tempo: Baseline (Month 0), 6 months
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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.
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Baseline (Month 0), 6 months
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Preference/Willingness to Try
Lasso di tempo: Baseline (Month 0), 6 months
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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.
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Baseline (Month 0), 6 months
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Attitudes
Lasso di tempo: Baseline (Month 0), 6 months
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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'
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Baseline (Month 0), 6 months
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Food source to product - knowledge
Lasso di tempo: Baseline (Month 0), 6 months
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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.
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Baseline (Month 0), 6 months
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Trust
Lasso di tempo: Baseline (Month 0), 6 months
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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).
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Baseline (Month 0), 6 months
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School food environment observation
Lasso di tempo: Baseline (Month 0), 6 months
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Observational proforma designed to allow researcher to assess current school food environment.
Developed by research team.
Completed by researcher.
Observational-open-ended responses.
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Baseline (Month 0), 6 months
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School food environment questionnaire
Lasso di tempo: Baseline (Month 0), 6 months
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Questionnaire designed to assess current school food environment.
Developed by research team.
Completed by school principal/management
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Baseline (Month 0), 6 months
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Exposure to/Experience with Agri-Food
Lasso di tempo: Baseline only (Month 0)
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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.
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Baseline only (Month 0)
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Baseline Skills Scale
Lasso di tempo: Baseline only (Month 0)
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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).
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Baseline only (Month 0)
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Daire Evaluation questionnaire
Lasso di tempo: 6 months only
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Process Evaluation questionnaire for both Nourish and Engage interventions completed by teachers.
Developed by research team.
Categorical and op-ended responses.
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6 months only
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jayne Woodside, PhD, Queen's University, Belfast
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
7 gennaio 2019
Completamento primario (Effettivo)
27 giugno 2019
Completamento dello studio (Effettivo)
27 giugno 2019
Date di iscrizione allo studio
Primo inviato
11 febbraio 2020
Primo inviato che soddisfa i criteri di controllo qualità
17 febbraio 2020
Primo Inserito (Effettivo)
20 febbraio 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 febbraio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 febbraio 2020
Ultimo verificato
1 febbraio 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 038_1819
- RD1014267 (Altro numero di sovvenzione/finanziamento: Invest NI)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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Andrzej Frycz Modrzewski Krakow UniversityReclutamentoSoffocando nei neonati | Rianimazione cardiopolmonare (CPR) | Formazione di pronto soccorso | Knowledg dei genitoriPolonia