Clinical trial NCT06057324: Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns
Official title: Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns by Combining Digital Interactive Tools with Targeted Educational Material and Sustainable Snacks
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy Subjects
Behavior, Health
Family
Keywords: Mediterranean Diet
Adherence
Family
Nutritional intervention
Sustainability
Educational Activities
Healthy Food Choice
Digital Technology
Healthy food
Lead sponsor: Fundació Eurecat
Sponsor class: OTHER
Collaborators: name: Centre de Recerca en Economia i Desenvolupament Agroalimentari-UPC-IRTA (CREDA)
name: Unité Mixte de Recherche en Nutrition et Alimentation, Université Ibn Tofail (CNESTEN)
name: Bursa Uludag University (BUU)
First posted: 2023-09-28
Enrollment: 480
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre, parallel, randomized, single-blind and controlled clinical trial
Primary purpose: PREVENTION

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.

Detailed description: The main outcome will be adherence to the MD assessed through MEDAS and KIDMED validated questionnaires in parents and children respectively. The effectiveness of the multi-component intervention will be evaluated by comparing the MEDAS and KIDMED scores between the control and intervention groups at baseline and at the end of the intervention.The secondary outcomes will include a set of anthropometrical, lifestyle, dietary and socio-economic indicators measured in all family members.

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.

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.

Primary outcomes:
measure: Change in adherence to the Mediterranean Diet
timeFrame: Phase 2 (month 10 to month 13)
measure: Change in adherence to the Mediterranean Diet
timeFrame: Phase 2 (month 10 to month 13)
Secondary outcomes:
measure: Change in Body Mass Index values
timeFrame: Phase 2 (month 10 to month 13)
measure: Change in waist circumference values
timeFrame: Phase 2 (month 10 to month 13)
measure: Change in blood pressure values
timeFrame: Phase 2 (month 10 to month 13)
measure: Change in resting heart rate values
timeFrame: Phase 2 (month 10 to month 13)
measure: Sociodemographic and socioeconomic data
timeFrame: Phase 1 (baseline)
measure: Social factors data
timeFrame: Phase 1 (baseline)
measure: Change in physical activity levels
timeFrame: Phase 2 (month 10 to month 13)
measure: Change in physical activity levels
timeFrame: Phase 2 (month 10 to month 13)
measure: Change in quality of life
timeFrame: Phase 2 (month 10 to month 13)
measure: Change in quality of life
timeFrame: Phase 2 (month 10 to month 13)
measure: Change in nutritional knowledge
timeFrame: Phase 2 (month 10 to month 13)
measure: Change in nutritional knowledge
timeFrame: Phase 2 (month 10 to month 13)
measure: Change in the health factor
timeFrame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
measure: Change in Mediterranean Diet lifestyle habits
timeFrame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
measure: Change in diet quality
timeFrame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
measure: Change in diet quality
timeFrame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
measure: Change in attitudes and beliefs in relation to food
timeFrame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
measure: Change in consumption behavior
timeFrame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
measure: Change in environmental impact
timeFrame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
measure: Change in economic impact
timeFrame: Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Eurecat, Technological Center of Catalonia, Nutrition and Health Unit
state: Tarragona
Study officials:
affiliation: Fundació Eurecat
name: Antoni Caimari Palou, PhD
role: PRINCIPAL_INVESTIGATOR
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