Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns

NCT06057324 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2025-03-03

No results posted yet for this study

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.

Conditions

  • Healthy Subjects
  • Behavior, Health
  • Family

Interventions

DEVICE

AI-based Apps

Families which will use the digital interactive tools to empower parents in their daily dietary choices.

BEHAVIORAL

Mediterranean-based diet toolkit and activities

Families which will receive educational materials and adolescents will perform educational activities.

OTHER

Healthy plant-based snacks

Families in which children will include the snacks in their diet.

OTHER

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.

OTHER

AI-based Apps + Healthy plant-based snacks

Families which will use the digital interactive tools and children will include the snacks in their diet.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Centre de Recerca en Economia i Desenvolupament Agroalimentari-UPC-IRTA (CREDA)

    collaborator UNKNOWN
  • Unité Mixte de Recherche en Nutrition et Alimentation, Université Ibn Tofail (CNESTEN)

    collaborator UNKNOWN
  • Bursa Uludag University (BUU)

    collaborator UNKNOWN
  • Fundació Eurecat

    lead OTHER

Principal Investigators

  • Antoni Caimari Palou, PhD · Fundació Eurecat

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-04-30
Completion
2025-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06057324 on ClinicalTrials.gov