Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns

Sponsor

Fundació Eurecat (Other)

Overall Status

Recruiting

CT.gov ID

NCT06057324

Collaborator

Centre de Recerca en Economia i Desenvolupament Agroalimentari-UPC-IRTA (CREDA) (Other), Unité Mixte de Recherche en Nutrition et Alimentation, Université Ibn Tofail (CNESTEN) (Other), Bursa Uludag University (BUU) (Other)

480

Enrollment

Location

Arms

Anticipated Duration (Months)

36.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects Behavior, Health Family	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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicentre, parallel, randomized, single-blind and controlled clinical trialMulticentre, parallel, randomized, single-blind and controlled clinical trial

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: Control group Families which will not follow any intervention; they will receive basic Mediterranean guidelines for parents and their children.

Arm

Intervention/Treatment

Experimental: 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.

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.

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

Change in adherence to the Mediterranean Diet [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.
Change in adherence to the Mediterranean Diet [Phase 2 (month 10 to month 13)]
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.

Secondary Outcome Measures

Change in Body Mass Index values [Phase 2 (month 10 to month 13)]
BMI will be assessed by weight (kg) / height (m2) and using a body composition analyzer (Tanita). BMI values will be compared between control and intervention groups. Measured in all family members.
Change in waist circumference values [Phase 2 (month 10 to month 13)]
Waist circumference (cm) will be measured at the umbilicus level using an anthropometric steel measuring tape. The obtained values will be compared between control and intervention groups. Measured in all family members.
Change in blood pressure values [Phase 2 (month 10 to month 13)]
Systolic blood pressure and Diastolic blood pressure values (mmHg) will be monitored by using an automatic sphygmomanometer. The obtained results will be compared between control and intervention groups. Measured in all family members.
Change in resting heart rate values [Phase 2 (month 10 to month 13)]
Resting heart rate values (bpm) will be monitored by using an automatic sphygmomanometer. The obtained results will be compared between control and intervention groups. Measured in all family members.
Sociodemographic and socioeconomic data [Phase 1 (baseline)]
Measured in parents and adolescents by an adapted questionnaire which will collect information regarding age, gender, household members, marital status, income, level of education and employment status.
Social factors data [Phase 1 (baseline)]
Measured in parents, adolescents, and children over 8 years by an adapted questionnaire which will collect information regarding work flexibility and satisfaction, work-life balance, lifestyle, time spent with children, family decision making, and task responsibility.
Change in physical activity levels [Phase 2 (month 10 to month 13)]
Physical activity level will be measured by using the Physical Activity Questionnaires PAQ-C for children over 8 years. It consists of a 10-item validated scale. The resulting score ranges from 1 to 5. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity. The obtained scores will be compared between control and intervention groups.
Change in physical activity levels [Phase 2 (month 10 to month 13)]
Physical activity level will be measured by using the Physical Activity Questionnaires PAQ-A for adolescent. It consists of a 9-item validated scale. The resulting score ranges from 1 to 5. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity. The obtained scores will be compared between control and intervention groups.
Change in physical activity levels [Phase 2 (month 10 to month 13)]
Physical activity level will be measured by using the International Physical Activity Questionnaire (IPAQ) for adults (parents). It consists of a 7-item short form with open-ended questions surrounding individuals' last 7-day recall of physical activity. Results are reported as categories (low activity levels, moderate activity levels or high activity levels). The obtained results will be compared between control and intervention groups.
Change in quality of life [Phase 2 (month 10 to month 13)]
Quality of life will be measured by using the 5-level EQ-5D-5L scale (EuroQol Group) for adults (parents). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The subject is asked to indicate his/her health state in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The obtained scores will be compared between control and intervention groups.
Change in quality of life [Phase 2 (month 10 to month 13)]
Quality of life will be measured by using the KIDSCREEN questionnaire for adolescents and children over 8 years. This scale measures 10 health-related quality of life dimensions: Physical- (5 items), Psychological Well-being (6 items), Moods and Emotions (7 items), Self-Perception (5 items), Autonomy (5 items), Parent Relations and Home Life (6 items), Social Support and Peers (6 items), School Environment (6 items), Social Acceptance (Bullying) (3 items), Financial Resources (3 items). The obtained scores will be compared between control and intervention groups.
Change in nutritional knowledge [Phase 2 (month 10 to month 13)]
Knowledge about food and nutrition will be measured using a short consumer-oriented nutrition knowledge questionnaire for adults. The questionnaire consists of a scale of 20 items where correct responses are scored as one, while incorrect responses, don't know-answers or blanks are scored as zero. The obtained final scores will be compared between control and intervention groups.
Change in nutritional knowledge [Phase 2 (month 10 to month 13)]
Knowledge about food and nutrition will be measured using the HELENA (Healthy Lifestyle in Europe by Nutrition in Adolescence) study questionnaire for adolescents. The questionnaire includes a total of 23 multiple-choice questions that can be categorized into specific subscales regarding knowledge of concepts (e.g. subscales 'Energy Intake and Energy Metabolism' or 'Physical Activity'), instrumental knowledge (e.g. subscale 'Nutrient Contents') and knowledge of causal relationships (e.g. subscales 'Sweeteners' or 'Oral Health'). Each question offers three possible answers (only one correct) and the 'don't know' category. Correct answers are scored as 1 and incorrect answers are scored as 0. Finally, the individual scores are summed up and calculated as a percentage of the total. The obtained final scores will be compared between control and intervention groups.
Change in the health factor [Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)]
The health factor will be assessed by the General Health Questionnaire (GHQ). This questionnaire will ask different aspects related to health and healthy lifestyle such as sleeping habits, hospitalization, or prescribed medications. The obtained results will be compared between control and intervention groups. Measured in all family members.
Change in Mediterranean Diet lifestyle habits [Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)]
Measured in parents by the Mediterranean Lifestyle index (MEDLIFE), which will capture adherence to an overall Mediterranean healthy lifestyle. It consists of a 28-item questionnaire categorized into three blocks: (1) Mediterranean food consumption (15 items); (2) Mediterranean dietary habits (7 items); (3) Physical Activity, rest, social habits and conviviality (6 items). Each item is scored as 0 for not meeting the cutoff established for the item or 1 for meeting it, so that the complete MEDLIFE ranges from 0 to 28, with a higher value indicative of greater adherence to Mediterranean lifestyle. The obtained results will be compared between control and intervention groups.
Change in diet quality [Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)]
Diet quality will be measured by using the Healthy Diet Index (HDI) for adults. It consists of seven weighted domains (meal pattern, grains, fruit and vegetables, fats, fish and meat, dairy, snacks, and treats). Within each domain, increasing points indicate a more healthy diet. The maximum total HDI is set at 100 points. The obtained results will be compared between control and intervention groups.
Change in diet quality [Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)]
Diet quality will be measured by using the KIDMED questionnaire for adolescent and children. The KIDMED score ranges from 0 to 12 points, so a score greater than or equal to 8 points means optimal diet quality 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. The obtained score will be compared between control and intervention groups.
Change in attitudes and beliefs in relation to food [Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)]
Measured by an adapted questionnaire for parents. This questionnaire measures how the household income, parents' time spent with children, and parents' work experiences affect children's energy and fat intake and obesity-related outcomes. The obtained results will be compared between control and intervention groups.
Change in consumption behavior [Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)]
The consumption patterns will be assessed by means of family weekly food purchases, food intakes and food waste. The food purchases will be monitored by family unit using shopping tickets collected for 1 week. The food intake will be measured in all family by a 7-day semi-weighted food record. The food waste will be calculated as the difference between families food purchases and consumption considering the initial and final food inventories. Food storage sheets will be used to estimate the balance between food purchased and stored at home.
Change in environmental impact [Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)]
The environmental impact of food consumption will be assessed of the overall study and the intervention. The consumption quantities will be converted into kg of CO2 emission, land use and water footprint using existing tables in the literature on the environmental impacts of different food groups.
Change in economic impact [Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)]
The economic impact of the overall study and the intervention will be estimated using the family shopping tickets. We will evaluate whether the interventions lead to any change in family food expenditures.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurecat, Technological Center of Catalonia, Nutrition and Health Unit	Reus	Tarragona	Spain	43204

Sponsors and Collaborators

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