Project Daire: Derry/Londonderry as the Nexus City for Food, Education, Trust and Health (Daire)
17 lutego 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Status
Zakończony
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
Zapisy
1080
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Northern Ireland
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Belfast, Northern Ireland, Zjednoczone Królestwo, BT12 6BJ
- Centre for Public Health, Queen's University Belfast
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
6 lat do 11 lat (Dziecko)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
4
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Eksperymentalny: 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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Eksperymentalny: 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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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in KIDSCREEN-10 score at 6 months
Ramy czasowe: 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.
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Baseline (Month 0), 6 months
|
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Change in Strengths and Difficulties Questionnaire score at 6 months
Ramy czasowe: 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.
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Baseline (Month 0), 6 months
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
24 Hour Dietary Record
Ramy czasowe: Baseline (Month 0), 6 months
|
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
Ramy czasowe: Baseline (Month 0), 6 months
|
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.
|
Baseline (Month 0), 6 months
|
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Food Shopping, Preparation & Consumption
Ramy czasowe: Baseline (Month 0), 6 months
|
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
Ramy czasowe: Baseline (Month 0), 6 months
|
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
Ramy czasowe: Baseline (Month 0), 6 months
|
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
Ramy czasowe: Baseline (Month 0), 6 months
|
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
Ramy czasowe: Baseline (Month 0), 6 months
|
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
Ramy czasowe: Baseline (Month 0), 6 months
|
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
Ramy czasowe: Baseline (Month 0), 6 months
|
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
Ramy czasowe: 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
Ramy czasowe: Baseline (Month 0), 6 months
|
Observational proforma designed to allow researcher to assess current school food environment.
Developed by research team.
Completed by researcher.
Observational-open-ended responses.
|
Baseline (Month 0), 6 months
|
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School food environment questionnaire
Ramy czasowe: Baseline (Month 0), 6 months
|
Questionnaire designed to assess current school food environment.
Developed by research team.
Completed by school principal/management
|
Baseline (Month 0), 6 months
|
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Exposure to/Experience with Agri-Food
Ramy czasowe: Baseline only (Month 0)
|
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.
|
Baseline only (Month 0)
|
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Baseline Skills Scale
Ramy czasowe: Baseline only (Month 0)
|
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).
|
Baseline only (Month 0)
|
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Daire Evaluation questionnaire
Ramy czasowe: 6 months only
|
Process Evaluation questionnaire for both Nourish and Engage interventions completed by teachers.
Developed by research team.
Categorical and op-ended responses.
|
6 months only
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Jayne Woodside, PhD, Queen's University, Belfast
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
7 stycznia 2019
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
27 czerwca 2019
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
27 czerwca 2019
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
11 lutego 2020
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
17 lutego 2020
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
20 lutego 2020
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
20 lutego 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 lutego 2020
Ostatnia weryfikacja
Ostatnia weryfikacja
1 lutego 2020
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 038_1819
- RD1014267 (Inny numer grantu/finansowania: Invest NI)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .