Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns

NCT06057324 | Enrolling By Invitation

• 2 other identifiers: SWITCHtoHEALTHY2133
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mediterranean Diet; Adherence; Family; Nutritional intervention; Sustainability; Educational Activities; Healthy Food Choice; Digital Technology; Healthy food

Outcome Measures

Primary Outcomes (2)

• Change in adherence to the Mediterranean Diet

  The main outcome will be adherence to the MD measured through MEDAS questionnaire score in parents. The effectiveness of the multi-component intervention will be evaluated by comparing the MEDAS score between the control and intervention groups during the intervention period (Phase 2). The MEDAS score is an extension of a 9-point score developed in the Prevention with Mediterranean Diet (PREDIMED) trial. A score of 14 points means maximum adherence to the Mediterranean Diet while a score below 7 points means low adherence.

  Phase 2 (month 10 to month 13)

• Change in adherence to the Mediterranean Diet

  The main outcome will be adherence to the MD measured through KIDMED questionnaire score in children. The effectiveness of the multi-component intervention will be evaluated by comparing the KIDMED score between the control and intervention groups during the intervention period (Phase 2). The KIDMED score ranges from 0 to 12 points, so a score greater than or equal to 8 points means optimal Mediterranean Diet adherence while a score below or equal to 3 points means very low-quality diet, and between 4 and 7 points means that need to improve the eating pattern to fit the Mediterranean pattern.

  Phase 2 (month 10 to month 13)

Secondary Outcomes (20)

• Change in Body Mass Index values

  Phase 2 (month 10 to month 13)

• Change in waist circumference values

  Phase 2 (month 10 to month 13)

• Change in blood pressure values

  Phase 2 (month 10 to month 13)

• Change in resting heart rate values

  Phase 2 (month 10 to month 13)

• Sociodemographic and socioeconomic data

  Phase 1 (baseline)

Study Arms (2)

Multi-component intervention groups

EXPERIMENTAL

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.

Device: AI-based Apps; Behavioral: Mediterranean-based diet toolkit and activities; Other: Healthy plant-based snacks; Other: AI-based Apps + Mediterranean-based diet toolkit and activities; Other: AI-based Apps + Healthy plant-based snacks; Other: Mediterranean-based diet toolkit and activities + Healthy plant-based snacks; Other: AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacks

Control group

NO INTERVENTION

Families which will not follow any intervention; they will receive basic Mediterranean guidelines for parents and their children.

Interventions

AI-based Apps DEVICE

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

Multi-component intervention groups

Mediterranean-based diet toolkit and activities BEHAVIORAL

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

Multi-component intervention groups

Healthy plant-based snacks OTHER

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

Multi-component intervention groups

AI-based Apps + Mediterranean-based diet toolkit and activities OTHER

Families which will use the digital interactive tools and receive educational material, and adolescents will perform educational activities.

Multi-component intervention groups

AI-based Apps + Healthy plant-based snacks OTHER

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

Multi-component intervention groups

Mediterranean-based diet toolkit and activities + Healthy plant-based snacks OTHER

Families which will receive educational material, adolescents will perform educational activities, and children will include the snacks in their diet.

Multi-component intervention groups

AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacks OTHER

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.

Multi-component intervention groups

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• No or limited access to the Internet.
• Being unable to follow the study guidelines.

Sponsors & Collaborators

• Fundació Eurecat: lead
• Centre de Recerca en Economia i Desenvolupament Agroalimentari-UPC-IRTA (CREDA): collaborator
• Unité Mixte de Recherche en Nutrition et Alimentation, Université Ibn Tofail (CNESTEN): collaborator
• Uludag University: collaborator

Study Sites (1)

Eurecat, Technological Center of Catalonia, Nutrition and Health Unit

Reus, Tarragona, 43204, Spain

Location

Related Publications (22)

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MeSH Terms

Conditions

Health Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Antoni Caimari Palou, PhD

  Fundació Eurecat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study, the participating families and researchers cannot be blinded to the intervention, although the researchers who will perform the data analysis will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, parallel, randomized, single-blind and controlled clinical trial

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: September 28, 2023
• Study Start: November 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)