Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns by Combining Digital Interactive Tools with Targeted Educational Material and Sustainable Snacks
Trial ID: NCT06057324
Status: ENROLLING_BY_INVITATION
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-11-01
Completion date: 2025-05
Sponsor: Fundació Eurecat
Collaborators: Centre de Recerca en Economia i Desenvolupament Agroalimentari-UPC-IRTA (CREDA); Unité Mixte de Recherche en Nutrition et Alimentation, Université Ibn Tofail (CNESTEN); Uludag University
Conditions: Healthy Subjects; Behavior, Health; Family
Interventions: AI-based Apps; Mediterranean-based diet toolkit and activities; Healthy plant-based snacks; AI-based Apps + Mediterranean-based diet toolkit and activities; AI-based Apps + Healthy plant-based snacks; Mediterranean-based diet toolkit and activities + Healthy plant-based snacks; AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacks
Locations: Eurecat, Technological Center of Catalonia, Nutrition and Health Unit
Countries: Spain
Enrollment: 480
Age range: 3 Years - None
Sex: ALL

Summary:
The population from Mediterranean countries is abandoning the Mediterranean diet (MD) traditional dietary and lifestyle pattern moving to unhealthier habits because of profound cultural and socio-economic driven lifestyle changes. Families, particularly parents, are responsible for structuring children's early experiences with food and eating as well as for transmitting knowledge of the MD. Educational family approaches can not only lead to more solid food literacy and healthy habits for children in the family but can also improve dietary profiles for adults, thus preventing future health-related problems. There is a lack of adequate study protocol for inducing a positive dietary, environmental and lifestyle behaviour in the family setting. SWITCHtoHEALTHY study aims to evaluate the effects of a multi-component nutritional intervention deployed at family level on the adherence to the MD pattern in families from three Mediterranean countries.

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.

Eligibility criteria:
Inclusion Criteria:

* Families from any socioeconomic status with at least one child less than 12 years and one adolescent older than or equal to 12 years (overall age range 3 - 17 years) and that live together.
* 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:

* Having allergies or food intolerances to any of the snack ingredients: fruit, vegetables, legumes, cereals, seeds, nuts (only for children under 12 years).
* 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.

Outcomes:
Change in adherence to the Mediterranean Diet; Change in adherence to the Mediterranean Diet