Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns
NCT ID: NCT06057324
Last Updated: 2025-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
480 participants
INTERVENTIONAL
2023-11-01
2025-05-31
Brief Summary
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A parallel, randomized, single blind controlled multicentric nutritional intervention study will be conducted in 480 families with children and adolescents among 3-17 years from Spain, Morocco, and Turkey over 13 months. Specifically, 160 families per country will be enrolled in a multi-component intervention and allocated to use digital interactive tools, hands-on educational materials and activities for adolescents, easy-to-eat healthy plant-based snacks for children, or a combination of two or three of the components. There will also be a control group that will receive general advice on healthy eating. The intervention study is scheduled to begin in November 2023.
Through the digital tools the parents will use an interactive App through which they will receive personalized weekly meal plans while the engagement of all the family will be prompted by using a life simulation game. A set of activities for adolescents based on a learning-through-play approach to be carried out within the family and at school will be developed by adolescents and voluntary schoolteachers through co-creation sessions. The innovative and sustainable plant-based snacks will be produced by local food companies and introduced in the children dietary plan as healthy alternatives for between meals. By using a full-factorial design, the independent and combined effects of each intervention component will be tested by comparing the 7 intervention groups with the control group.
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Detailed Description
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Standardized protocols will be used for the collection of data in the three countries. All data will be collected and evaluated by professional researchers and registered by researchers or study participants in a web platform. Lifestyle, diet, and socio-economic indicators will be self-reported by means of adapted online questionnaires for parent, adolescent, and child.
The study will be carried out in 2 phases:
* Phase 1 (month 0 to month 9): the families will be included in the study, they will be assigned to the different intervention groups, and consumption patterns and lifestyle, diet, and socioeconomic indicators will be evaluated through specific questionnaires. In addition, the different educational materials, activities, digital interactive tools and healthy snacks will be developed prior to the start of the intervention study.
* Phase 2 (month 10 to month 13): The intervention study will be deployed at family level. Each family will receive the educational materials, digital interactive tools and snacks developed in Phase 1 as assigned. In addition, anthropometric, lifestyle, dietary and socioeconomic indicators will be evaluated through questionnaires.
Three visits will be performed along the study, including one pre-assessment at the beginning of Phase 1 (baseline, month 0), one visit at the beginning of Phase 2 (month 11) and one visit at the end of Phase 2 (month 13).
The impact of the intervention on dietary factors, including MD adherence, diet quality, food intake and MD lifestyle habits, physical activity, and classical anthropometrical parameters, will be assessed in Phase 2 in a 3-month period. However, consumption behaviour and environmental and economic factors will be measured at the baseline (Phase 1) and at the end (Phase 2). The baseline point (month 0) is necessary to assess the aforementioned factors over the course of a year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Multi-component intervention groups
Multi-component intervention with non-invasive approaches:
-Digital interactive tools (AI-based Apps): They will consist of a combination of two Artificial Intelligence (AI) Apps that will be used by parents to empower them in their daily dietary choices for children's dietary plan.
\- Educational materials (Mediterranean-based diet toolkit) and activities: The toolkit will include a set of specific games and activities for kids designed to facilitate the ''learning through playing'' approach improving their understanding of different nutrition themes. The educational activities will be co-designed and carried out by adolescents outside of school hours.
\- Healthy plant-based snacks: They will be adapted to children's nutritional requirements and to be consumed in-between time on a daily basis. Based on local and traditional products for each country including vegetables, fruits, legumes, seeds and nuts as main ingredients.
AI-based Apps
Families which will use the digital interactive tools to empower parents in their daily dietary choices.
Mediterranean-based diet toolkit and activities
Families which will receive educational materials and adolescents will perform educational activities.
Healthy plant-based snacks
Families in which children will include the snacks in their diet.
AI-based Apps + Mediterranean-based diet toolkit and activities
Families which will use the digital interactive tools and receive educational material, and adolescents will perform educational activities.
AI-based Apps + Healthy plant-based snacks
Families which will use the digital interactive tools and children will include the snacks in their diet.
Mediterranean-based diet toolkit and activities + Healthy plant-based snacks
Families which will receive educational material, adolescents will perform educational activities, and children will include the snacks in their diet.
AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacks
Families which will use the digital interactive tools and will receive educational material, children will include the snacks in their diet, and adolescents will perform educational activities.
Control group
Families which will not follow any intervention; they will receive basic Mediterranean guidelines for parents and their children.
No interventions assigned to this group
Interventions
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AI-based Apps
Families which will use the digital interactive tools to empower parents in their daily dietary choices.
Mediterranean-based diet toolkit and activities
Families which will receive educational materials and adolescents will perform educational activities.
Healthy plant-based snacks
Families in which children will include the snacks in their diet.
AI-based Apps + Mediterranean-based diet toolkit and activities
Families which will use the digital interactive tools and receive educational material, and adolescents will perform educational activities.
AI-based Apps + Healthy plant-based snacks
Families which will use the digital interactive tools and children will include the snacks in their diet.
Mediterranean-based diet toolkit and activities + Healthy plant-based snacks
Families which will receive educational material, adolescents will perform educational activities, and children will include the snacks in their diet.
AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacks
Families which will use the digital interactive tools and will receive educational material, children will include the snacks in their diet, and adolescents will perform educational activities.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent (parents will sign on their own behalf and of the child under 12 years of age and the adolescent. The adolescent must also sign themselves).
* To have a mobile phone, tablet, or computer with internet access.
Exclusion Criteria
* Dislike any of the snacks (only for children under 12 years).
* Mediterranean Diet Adherence Score (MEDAS) among 8-14 or KIDMED score among 8-12, which is a food pattern already highly concordant with the Mediterranean Diet.
* Following a vegan diet any of the family members.
* Following a prescribed long-term and strict diet for any reason, including diets for weight loss and diets for chronic metabolic or autoimmune disorders such as type 1 diabetes, celiac disease, inflammatory bowel disease or rheumatoid arthritis (any of the family members).
* Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
* No or limited access to the Internet.
* Being unable to follow the study guidelines.
3 Years
ALL
Yes
Sponsors
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Centre de Recerca en Economia i Desenvolupament Agroalimentari-UPC-IRTA (CREDA)
UNKNOWN
Unité Mixte de Recherche en Nutrition et Alimentation, Université Ibn Tofail (CNESTEN)
UNKNOWN
Bursa Uludag University (BUU)
UNKNOWN
Fundació Eurecat
OTHER
Responsible Party
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Principal Investigators
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Antoni Caimari Palou, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundació Eurecat
Locations
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Eurecat, Technological Center of Catalonia, Nutrition and Health Unit
Reus, Tarragona, Spain
Countries
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References
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Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25.
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Other Identifiers
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2133
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SWITCHtoHEALTHY
Identifier Type: -
Identifier Source: org_study_id
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