Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns by Combining Digital Interactive Tools with Targeted Educational Material and Sustainable Snacks
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Change in adherence to the Mediterranean Diet
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
Families which will not follow any intervention; they will receive basic Mediterranean guidelines for parents and their children.
Multi-component intervention groups
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.
干预措施: AI-based Apps (Device)
Multi-component intervention groups
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.
干预措施: Mediterranean-based diet toolkit and activities (Behavioral)
Multi-component intervention groups
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.
干预措施: Healthy plant-based snacks (Other)
Multi-component intervention groups
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.
干预措施: AI-based Apps + Mediterranean-based diet toolkit and activities (Other)
Multi-component intervention groups
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.
干预措施: AI-based Apps + Healthy plant-based snacks (Other)
Multi-component intervention groups
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.
干预措施: Mediterranean-based diet toolkit and activities + Healthy plant-based snacks (Other)
Multi-component intervention groups
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.
干预措施: AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacks (Other)
结局指标
主要结局
Change in adherence to the Mediterranean Diet
时间窗: Phase 2 (month 10 to month 13)
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.
次要结局
- Change in Body Mass Index values(Phase 2 (month 10 to month 13))
- Social factors data(Phase 1 (baseline))
- Change in Mediterranean Diet lifestyle habits(Phase 1 (month 0 to month 9) and 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))
- Change in the health factor(Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13))
- Change in environmental impact(Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13))
- Change in waist circumference values(Phase 2 (month 10 to month 13))
- Sociodemographic and socioeconomic data(Phase 1 (baseline))
- Change in consumption behavior(Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13))
- Change in attitudes and beliefs in relation to food(Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13))
- Change in economic impact(Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13))
- Change in diet quality(Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13))
- Change in physical activity levels(Phase 2 (month 10 to month 13))
- Change in quality of life(Phase 2 (month 10 to month 13))
- Change in nutritional knowledge(Phase 2 (month 10 to month 13))