Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns

Официальное название

Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns by Combining Digital Interactive Tools with Targeted Educational Material and Sustainable Snacks

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство AI-based Apps
  Families which will use the digital interactive tools to empower parents in their daily dietary choices.
• Поведенческое Mediterranean-based diet toolkit and activities
  Families which will receive educational materials and adolescents will perform educational activities.
• Другое Healthy plant-based snacks
  Families in which children will include the snacks in their diet.
• Другое 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.
• Другое AI-based Apps + Healthy plant-based snacks
  Families which will use the digital interactive tools and children will include the snacks in their diet.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Change in adherence to the Mediterranean Diet [Срок оценки: Phase 2 (month 10 to month 13)]
• Change in adherence to the Mediterranean Diet [Срок оценки: Phase 2 (month 10 to month 13)]

Вторичные конечные точки (12)

• Change in Body Mass Index values [Срок оценки: Phase 2 (month 10 to month 13)]
• Change in waist circumference values [Срок оценки: Phase 2 (month 10 to month 13)]
• Change in blood pressure values [Срок оценки: Phase 2 (month 10 to month 13)]
• Change in resting heart rate values [Срок оценки: Phase 2 (month 10 to month 13)]
• Sociodemographic and socioeconomic data [Срок оценки: Phase 1 (baseline)]
• Social factors data [Срок оценки: Phase 1 (baseline)]
• Change in physical activity levels [Срок оценки: Phase 2 (month 10 to month 13)]
• Change in physical activity levels [Срок оценки: Phase 2 (month 10 to month 13)]
• Change in quality of life [Срок оценки: Phase 2 (month 10 to month 13)]
• Change in quality of life [Срок оценки: Phase 2 (month 10 to month 13)]
• Change in nutritional knowledge [Срок оценки: Phase 2 (month 10 to month 13)]
• Change in nutritional knowledge [Срок оценки: Phase 2 (month 10 to month 13)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Eurecat, Technological Center of Catalonia, Nutrition and Health Unit — Reus

Публикации

• Alonso-Dominguez R, Garcia-Ortiz L, Patino-Alonso MC, Sanchez-Aguadero N, Gomez-Marcos MA, Recio-Rodriguez JI. Effectiveness of A Multifactorial Intervention in Increasing Adherence to the Mediterranean Diet among Patients with Diabetes Mellitus Type 2: A Controlled and Randomized Study (EMID Study). Nutrients. 2019 Jan 14;11(1):162. doi: 10.3390/nu11010162. PMID 30646500
• Sichert-Hellert W, Beghin L, De Henauw S, Grammatikaki E, Hallstrom L, Manios Y, Mesana MI, Molnar D, Dietrich S, Piccinelli R, Plada M, Sjostrom M, Moreno LA, Kersting M; HELENA Study Group. Nutritional knowledge in European adolescents: results from the HELENA (Healthy Lifestyle in Europe by Nutrition in Adolescence) study. Public Health Nutr. 2011 Dec;14(12):2083-91. doi: 10.1017/S1368980011001 PMID 21810282
• Dickson-Spillmann M, Siegrist M, Keller C. Development and validation of a short, consumer-oriented nutrition knowledge questionnaire. Appetite. 2011 Jun;56(3):617-20. doi: 10.1016/j.appet.2011.01.034. Epub 2011 Feb 15. PMID 21310201
• Ravens-Sieberer U, Gosch A, Abel T, Auquier P, Bellach BM, Bruil J, Dur W, Power M, Rajmil L; European KIDSCREEN Group. Quality of life in children and adolescents: a European public health perspective. Soz Praventivmed. 2001;46(5):294-302. doi: 10.1007/BF01321080. PMID 11759336
• Sotos-Prieto M, Santos-Beneit G, Bodega P, Pocock S, Mattei J, Penalvo JL. VALIDATION OF A QUESTIONNAIRE TO MEASURE OVERALL MEDITERRANEAN LIFESTYLE HABITS FOR RESEARCH APPLICATION: THE MEDITERRANEAN LIFESTYLE INDEX (MEDLIFE). Nutr Hosp. 2015 Sep 1;32(3):1153-63. doi: 10.3305/nh.2015.32.3.9387. PMID 26319833
• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB. PMID 12900694
• Rodriguez-Rodriguez F, Galvez-Fernandez P, Huertas-Delgado FJ, Aranda-Balboa MJ, Saucedo-Araujo RG, Herrador-Colmenero M. Parent's sociodemographic factors, physical activity and active commuting are predictors of independent mobility to school. Int J Health Geogr. 2021 Jun 6;20(1):26. doi: 10.1186/s12942-021-00280-2. PMID 34090437
• Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556. PMID 15482620

Идентификаторы

NCT: NCT06057324 · SWITCHtoHEALTHY · 2133

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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