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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04277312
Other study ID # 038_1819
Secondary ID RD1014267
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date June 27, 2019

Study information

Verified date February 2020
Source Queen's University, Belfast
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 1080
Est. completion date June 27, 2019
Est. primary completion date June 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 11 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
United Kingdom Centre for Public Health, Queen's University Belfast Belfast Northern Ireland

Sponsors (2)

Lead Sponsor Collaborator
Queen's University, Belfast Invest NI

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in KIDSCREEN-10 score at 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
Primary Change in Strengths and Difficulties Questionnaire score at 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
Secondary 24 Hour Dietary Record 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
Secondary Food Frequency Questionnaire 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
Secondary Food Shopping, Preparation & Consumption 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
Secondary Perceived cooking competence 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
Secondary Agri-Food Knowledge 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
Secondary Food Jobs/Careers Aspirations 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
Secondary Preference/Willingness to Try 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
Secondary Attitudes 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
Secondary Food source to product - knowledge 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
Secondary Trust 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
Secondary School food environment observation 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
Secondary School food environment questionnaire Questionnaire designed to assess current school food environment. Developed by research team. Completed by school principal/management Baseline (Month 0), 6 months
Secondary Exposure to/Experience with Agri-Food 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)
Secondary Baseline Skills Scale 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)
Secondary Daire Evaluation questionnaire 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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