Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06057324
• Other study ID #: SWITCHtoHEALTHY
• Secondary ID: 2133
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Fundació Eurecat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 480
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Health
• Family
• Healthy Subjects

Intervention

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.
• 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.
• AI-based Apps + Healthy plant-based snacks
Families which will use the digital interactive tools and children will include the snacks in their diet.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Eurecat, Technological Center of Catalonia, Nutrition and Health Unit	Reus	Tarragona

Sponsors (4)

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

Country where clinical trial is conducted

Spain, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in Body Mass Index values	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.	Phase 2 (month 10 to month 13)
Secondary	Change in waist circumference values	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.	Phase 2 (month 10 to month 13)
Secondary	Change in blood pressure values	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.	Phase 2 (month 10 to month 13)
Secondary	Change in resting heart rate values	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.	Phase 2 (month 10 to month 13)
Secondary	Sociodemographic and socioeconomic data	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.	Phase 1 (baseline)
Secondary	Social factors data	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.	Phase 1 (baseline)
Secondary	Change in physical activity levels	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.	Phase 2 (month 10 to month 13)
Secondary	Change in physical activity levels	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.	Phase 2 (month 10 to month 13)
Secondary	Change in quality of life	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.	Phase 2 (month 10 to month 13)
Secondary	Change in quality of life	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.	Phase 2 (month 10 to month 13)
Secondary	Change in nutritional knowledge	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.	Phase 2 (month 10 to month 13)
Secondary	Change in nutritional knowledge	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.	Phase 2 (month 10 to month 13)
Secondary	Change in the health factor	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.	Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Secondary	Change in Mediterranean Diet lifestyle habits	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.	Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Secondary	Change in diet quality	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.	Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Secondary	Change in diet quality	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.	Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Secondary	Change in attitudes and beliefs in relation to food	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.	Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Secondary	Change in consumption behavior	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.	Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Secondary	Change in environmental impact	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.	Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)
Secondary	Change in economic impact	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.	Phase 1 (month 0 to month 9) and Phase 2 (month 10 to month 13)