Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Project Daire: Derry/Londonderry as the Nexus City for Food, Education, Trust and Health (Daire)

17. února 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

1080

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Northern Ireland
      • Belfast, Northern Ireland, Spojené království, BT12 6BJ
        • Centre for Public Health, Queen's University Belfast

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

6 let až 11 let (Dítě)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
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.
Experimentální: 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.
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.
Experimentální: Nourish and Engage
This arm of the intervention delivered both the Nourish and Engage interventions as detailed above.
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.
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in KIDSCREEN-10 score at 6 months
Časové okno: 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.
Baseline (Month 0), 6 months
Change in Strengths and Difficulties Questionnaire score at 6 months
Časové okno: 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.
Baseline (Month 0), 6 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
24 Hour Dietary Record
Časové okno: 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.
Baseline (Month 0), 6 months
Food Frequency Questionnaire
Časové okno: 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
Food Shopping, Preparation & Consumption
Časové okno: 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.
Baseline (Month 0), 6 months
Perceived cooking competence
Časové okno: 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.
Baseline (Month 0), 6 months
Agri-Food Knowledge
Časové okno: 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.
Baseline (Month 0), 6 months
Food Jobs/Careers Aspirations
Časové okno: 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.
Baseline (Month 0), 6 months
Preference/Willingness to Try
Časové okno: 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.
Baseline (Month 0), 6 months
Attitudes
Časové okno: 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'
Baseline (Month 0), 6 months
Food source to product - knowledge
Časové okno: 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.
Baseline (Month 0), 6 months
Trust
Časové okno: Baseline (Month 0), 6 months
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).
Baseline (Month 0), 6 months
School food environment observation
Časové okno: 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
School food environment questionnaire
Časové okno: 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
Exposure to/Experience with Agri-Food
Časové okno: 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)
Baseline Skills Scale
Časové okno: 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)
Daire Evaluation questionnaire
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Spolupracovníci

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jayne Woodside, PhD, Queen's University, Belfast

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

7. ledna 2019

Primární dokončení (Aktuální)

27. června 2019

Dokončení studie (Aktuální)

27. června 2019

Termíny zápisu do studia

První předloženo

11. února 2020

První předloženo, které splnilo kritéria kontroly kvality

17. února 2020

První zveřejněno (Aktuální)

20. února 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. února 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. února 2020

Naposledy ověřeno

1. února 2020

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 038_1819
  • RD1014267 (Jiné číslo grantu/financování: Invest NI)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit