Project Daire: Derry/Londonderry as the Nexus City for Food, Education, Trust and Health (Daire)
17 de fevereiro de 2020 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
1080
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Northern Ireland
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Belfast, Northern Ireland, Reino Unido, BT12 6BJ
- Centre for Public Health, Queen's University Belfast
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
6 anos a 11 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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|
Experimental: 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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Experimental: 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in KIDSCREEN-10 score at 6 months
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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24 Hour Dietary Record
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jayne Woodside, PhD, Queen's University, Belfast
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de janeiro de 2019
Conclusão Primária (Real)
27 de junho de 2019
Conclusão do estudo (Real)
27 de junho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
11 de fevereiro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de fevereiro de 2020
Primeira postagem (Real)
20 de fevereiro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de fevereiro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de fevereiro de 2020
Última verificação
1 de fevereiro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 038_1819
- RD1014267 (Número de outro subsídio/financiamento: Invest NI)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .