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

17 de febrero de 2020 actualizado 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.

Descripción general del estudio

Estado

Terminado

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

1080

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 años a 11 años (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
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.
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.
Experimental: 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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in KIDSCREEN-10 score at 6 months
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
24 Hour Dietary Record
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Jayne Woodside, PhD, Queen's University, Belfast

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de enero de 2019

Finalización primaria (Actual)

27 de junio de 2019

Finalización del estudio (Actual)

27 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

11 de febrero de 2020

Primero enviado que cumplió con los criterios de control de calidad

17 de febrero de 2020

Publicado por primera vez (Actual)

20 de febrero de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de febrero de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

17 de febrero de 2020

Última verificación

1 de febrero de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 038_1819
  • RD1014267 (Otro número de subvención/financiamiento: Invest NI)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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