Family Researchn-CHEFSNCT05280652
Nutritional and Culinary Habits to Empower Families Towards Sustainability - a Multicentric Pilot Study
A study testing Nutritional and culinary intervention and Nutritional intervention in people with Family Research, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
Trial summary
Background: Different studies have shown that nutritional interventions can be effective in informing and educating the population about the need to follow a healthy diet to prevent obesity and other chronic diseases. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Research
- What is being tested?
- Nutritional and culinary intervention and Nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Sep 2022to 17 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child must be between 9-14 years old.
- The child is at risk of obesity because it is over cut-offs of BMI according to their age or because it has a low level of adherence to the Mediterranean dietary pattern (an score ≤7 points in the Kidmed questionnaire).
- There is at least 1 obesity risk factor in the household: one or both progenitors has overweight or obesity; one of both progenitors has only primary studies; one or both progenitors are unskilled workers; the total household number is ≤3; the child birthweight was >4 kg; biological mother smoked during pregnancy; biological mother's weight gain during pregnancy was greater than the cut-offs of weight according to her BMI before pregnancy; biological mother's BMI before pregnancy was ≥30 kg/m2; one or both progenitors has a low adherence to the Mediterranean diet (17 points Mediterranean diet score ≤8); or the score for the family nutrition and physical activity screening tool is ≤50.
Who cannot join
- The participant progenitor or child has any food allergies and intolerances incompatible with the Mediterranean diet (fruits, nuts).
- The participant progenitor or child follow a specific dietary pattern incompatible with the intervention.
- The participant progenitor or child has type 1 diabetes, severe diseases of the digestive system, kidney, cancer, other diseases that limit survival less than 1 year, or eating disorders.
- The family has not access to a PC, tablet or telephone with internet.
- The family has participated in cooking workshops in the past 3 years.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universidad de Alicante
Alicante
University of Navarra
Pamplona, Navarre, 31008
About this study
Official title: N-CHEFS (Nutritional and Culinary Habits to Empower Families Towards Sustainability) - a Multicentric Pilot Study
Background: Different studies have shown that nutritional interventions can be effective in informing and educating the population about the need to follow a healthy diet to prevent obesity and other chronic diseases. However, sometimes this knowledge is difficult to apply in daily life, which is usually marked by lack of time and easy access to food alternatives that are not healthy but can be more comfortable. These difficulties may be greater in families today since the lack of time is greater and it is a greater challenge to get minors to consume a high amount (5 servings a day) of fruits and vegetables. Culinary medicine is an emerging discipline that combines nutrition and gastronomy to increase the prevention and treatment of chronic diseases.
Objective: The main objective is to demonstrate whether a culinary-nutritional intervention in families reduces the risk of obesity and increases adherence to a healthy and sustainable diet.
Read more
Methods: The present project will cover culinary medicine and home-cooking as innovative strategies to improve the eating habits of families through an intervention based on face-to-face nutricional-culinary workshops and online material, where apart from receiving nutritional education, they will be taught a series of culinary techniques (adapted to adults and children) so that they learn to cook in an easy, enjoyable and family-friendly way, with tools to eat healthier in a simple and quick way.
The intervention will be carried out with 92 families (dyads 1 adult and 1 child) which will be randomized in a 1: 1: 2 ratio into three groups: group 1 (intervention with families) in which families will attend nutritional-culinary workshops with theoretical and practical information to follow a sustainable Mediterranean diet; group 2 (intervention with parents) in which only parents will attend nutritional-culinary workshops with theoretical and practical information to follow a sustainable Mediterranean diet; and group 3 (control) in which families will attend nutritional workshops with theoretical information to follow a sustainable Mediterranean diet.
UPDATED NOTE AFTER RECRUITMENT: Due to financial and recruitment issues, a total of 29 families were recruited.
Read the detailed description
The present pilot study is a multicentric study which will be carried out in two cities of Spain, Alicante and Madrid.
The study is divided into two periods: the 10-month intervention period and the 4-month follow-up period. The intervention period will be from May 2022 to February 2023 and the follow-up period from March 2023 to June 2023.
A total of 92 families will be included in the present study which will be randomized in a 1: 1: 2 ratio into three groups: group 1 (intervention with families) in which families will attend nutritional-culinary workshops with theoretical and practical information to follow a sustainable Mediterranean diet; group 2 (intervention with parents) in which only parents will attend nutritional-culinary workshops with theoretical and practical information to follow a sustainable Mediterranean diet; and group 3 (control) in which families will attend nutritional workshops with theoretical information to follow a sustainable Mediterranean diet.
The sample size was calculated according to the the results on the change in BMI between subjects who followed a culinary intervention vs subjects in the control group of the study by Gatto et al. (2017) (doi:10.1111/ijpo.12102). A sample size of 83 families (55 intervention group families, 28 control group families) was estimated to find a change between groups (intervention vs. control) in the z-score BMI of 0.06 points with a standard deviation (SD) of 0.09 points, with a power of 80% and an alpha error of 5%. Assuming a 10% dropout rate, the initial number of families recruited is increased to 92 (30-31 families in each of the three groups).
UPDATED NOTE AFTER RECRUITMENT: Due to financial and recruitment issues, a total of 29 families were recruited.
- Conditions
- Family Research
- Being tested
- Nutritional and culinary intervention, Nutritional intervention
- Keywords
- culinary medicine; home cooking; family-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional and culinary interventionBehavioural
Participants will attend 6 two-hours nutritional-culinary workshops between May 2022 and February 2023. All of the workshops will be held in a kitchen, and will be given in groups of 2 dyads or parents according to the intervention group. In addition, during the intervention families will be given access to a web page with nutrition and culinary education materials (infographics, videos).
Nutritional interventionBehavioural
Participants will attend 6 1-hour nutritional workshops between May 2022 and February 2023. The workshops will be held in person, and will be given in groups of 10-12 families. In addition, during the intervention families will be given access to a web page with nutrition education materials (infographics, videos).
| Study group | Role | What they receive |
|---|---|---|
| Family intervention group | Experimental | Families (dyads parent and child) will attend culinary-nutritional workshops with theoretical and practical nutritional and culinary information (knowledge and skills to prepare healthy and easy menus) to follow a sustainable Mediterranean diet. Receives: Behavioral: Nutritional and culinary intervention |
| Parent-only intervention group | Experimental | Parents will attend culinary-nutritional workshops with theoretical and practical nutritional and culinary information (knowledge and skills to prepare healthy and easy menus) to follow a sustainable Mediterranean diet. Receives: Behavioral: Nutritional and culinary intervention |
| Control | Active comparator | Families (dyads parent and child) will attend nutritional workshops with theoretical information to follow a sustainable Mediterranean diet. Receives: Behavioral: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the intervention on changes in body mass index (BMI)
Weight will be measured with a Tanita RD-545 (Tanita Corp Tokyo Japan). Height will be measured to the nearest 0.1 cm using a portable stadiometer. Differences between intervention groups on changes on BMI between baseline and 10-months and baseline and 14-months follow up.
Measured: At baseline, and 10 and 14 months follow-up
Secondary outcomes (3)
Effect of the intervention on home cooking habits
A validated questionnaire will be used to assess the use of different culinary techniques (Culinary Habits Frequency Questionnaire). Differences between intervention groups on changes on culinary habits between baseline and 10-months and baseline and 14-months follow up.
Measured: At baseline, and 10 and 14 months follow-up
Effect of the intervention on the adherence to the Mediterranean Diet (MedDiet)
Adherence to the MedDiet will be measured with the validated 17-item Mediterranean Diet Adherence questionnaire among aduls and the Kidmed questionnaire among children. Differences between intervention groups on changes on Mediterranean diet adherence between baseline and 10-months and baseline and 14-months follow up.
Measured: At baseline, and 10 and 14 months follow-up
Home cooking attitudes and self-confidence on cooking at home with the cooking attitudes and self-confidence questionnaire
A non-validated questionnaire that measures cooking attitudes and self-confidence will be used at baseline and after 10-months of follow-up. The "cooking self-confidence and attitudes questionnaire" includes 18 questions on self-confidence and 18 questions on attitudes. Each question includes a 5-item Likert scale answer. A higher score means a higher self-confidence or positive attitude on home cooking.
Measured: At baseline, and 10 and 14 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Sep 2022
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Family ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280652
- Sponsor's protocol ID
- 2021.124
- Acronym
- n-CHEFS
- Status last verified
- Dec 2024
- First submitted
- 4 Mar 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Enright G, Allman-Farinelli M, Redfern J. Effectiveness of Family-Based Behavior Change Interventions on Obesity-Related Behavior Change in Children: A Realist Synthesis. Int J Environ Res Public Health. 2020 Jun 8;17(11):4099. doi: 10.3390/ijerph17114099.
PubMed 32521815Smith JD, Montano Z, Dishion TJ, Shaw DS, Wilson MN. Preventing weight gain and obesity: indirect effects of the family check-up in early childhood. Prev Sci. 2015 Apr;16(3):408-19. doi: 10.1007/s11121-014-0505-z.
PubMed 25263212
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-CHEFS (Nutritional and Culinary Habits to Empower Families Towards Sustainability) - a Multicentric Pilot Study
- ClinicalTrials.gov ID
- NCT05280652
- Acronym / sponsor ID
- n-CHEFS / 2021.124
- Conditions
- Family Research
- Keywords
- culinary medicine; home cooking; family-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Different studies have shown that nutritional interventions can be effective in informing and educating the population about the need to follow a healthy diet to prevent obesity and other chronic diseases. However, sometimes this knowledge is difficult to apply in daily life, which is usually marked by lack of time and easy access to food alternatives that are not healthy but can be more comfortable. These difficulties may be greater in families today since the lack of time is greater and it is a greater challenge to get minors to consume a high amount (5 servings a day) of fruits and vegetables. Culinary medicine is an emerging discipline that combines nutrition and gastronomy to increase the prevention and treatment of chronic diseases.
Objective: The main objective is to demonstrate whether a culinary-nutritional intervention in families reduces the risk of obesity and increases adherence to a healthy and sustainable diet.
Methods: The present project will cover culinary medicine and home-cooking as innovative strategies to improve the eating habits of families through an intervention based on face-to-face nutricional-culinary workshops and online material, where apart from receiving nutritional education, they will be taught a series of culinary techniques (adapted to adults and children) so that they learn to cook in an easy, enjoyable and family-friendly way, with tools to eat healthier in a simple and quick way.
The intervention will be carried out with 92 families (dyads 1 adult and 1 child) which will be randomized in a 1: 1: 2 ratio into three groups: group 1 (intervention with families) in which families will attend nutritional-culinary workshops with theoretical and practical information to follow a sustainable Mediterranean diet; group 2 (intervention with parents) in which only parents will attend nutritional-culinary workshops with theoretical and practical information to follow a sustainable Mediterranean diet; and group 3 (control) in which families will attend nutritional workshops with theoretical information to follow a sustainable Mediterranean diet.
UPDATED NOTE AFTER RECRUITMENT: Due to financial and recruitment issues, a total of 29 families were recruited.
Detailed description
The present pilot study is a multicentric study which will be carried out in two cities of Spain, Alicante and Madrid.
The study is divided into two periods: the 10-month intervention period and the 4-month follow-up period. The intervention period will be from May 2022 to February 2023 and the follow-up period from March 2023 to June 2023.
A total of 92 families will be included in the present study which will be randomized in a 1: 1: 2 ratio into three groups: group 1 (intervention with families) in which families will attend nutritional-culinary workshops with theoretical and practical information to follow a sustainable Mediterranean diet; group 2 (intervention with parents) in which only parents will attend nutritional-culinary workshops with theoretical and practical information to follow a sustainable Mediterranean diet; and group 3 (control) in which families will attend nutritional workshops with theoretical information to follow a sustainable Mediterranean diet.
The sample size was calculated according to the the results on the change in BMI between subjects who followed a culinary intervention vs subjects in the control group of the study by Gatto et al. (2017) (doi:10.1111/ijpo.12102). A sample size of 83 families (55 intervention group families, 28 control group families) was estimated to find a change between groups (intervention vs. control) in the z-score BMI of 0.06 points with a standard deviation (SD) of 0.09 points, with a power of 80% and an alpha error of 5%. Assuming a 10% dropout rate, the initial number of families recruited is increased to 92 (30-31 families in each of the three groups).
UPDATED NOTE AFTER RECRUITMENT: Due to financial and recruitment issues, a total of 29 families were recruited.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Family intervention group | Experimental | Behavioral: Nutritional and culinary interventionFamilies (dyads parent and child) will attend culinary-nutritional workshops with theoretical and practical nutritional and culinary information (knowledge and skills to prepare healthy and easy menus) to follow a sustainable Mediterranean diet. |
| Parent-only intervention group | Experimental | Behavioral: Nutritional and culinary interventionParents will attend culinary-nutritional workshops with theoretical and practical nutritional and culinary information (knowledge and skills to prepare healthy and easy menus) to follow a sustainable Mediterranean diet. |
| Control | Active comparator | Behavioral: Nutritional interventionFamilies (dyads parent and child) will attend nutritional workshops with theoretical information to follow a sustainable Mediterranean diet. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The child must be between 9-14 years old.
- The child is at risk of obesity because it is over cut-offs of BMI according to their age or because it has a low level of adherence to the Mediterranean dietary pattern (an score ≤7 points in the Kidmed questionnaire).
- There is at least 1 obesity risk factor in the household: one or both progenitors has overweight or obesity; one of both progenitors has only primary studies; one or both progenitors are unskilled workers; the total household number is ≤3; the child birthweight was >4 kg; biological mother smoked during pregnancy; biological mother's weight gain during pregnancy was greater than the cut-offs of weight according to her BMI before pregnancy; biological mother's BMI before pregnancy was ≥30 kg/m2; one or both progenitors has a low adherence to the Mediterranean diet (17 points Mediterranean diet score ≤8); or the score for the family nutrition and physical activity screening tool is ≤50.
Key exclusion criteria (5 listed)
- The participant progenitor or child has any food allergies and intolerances incompatible with the Mediterranean diet (fruits, nuts).
- The participant progenitor or child follow a specific dietary pattern incompatible with the intervention.
- The participant progenitor or child has type 1 diabetes, severe diseases of the digestive system, kidney, cancer, other diseases that limit survival less than 1 year, or eating disorders.
- The family has not access to a PC, tablet or telephone with internet.
- The family has participated in cooking workshops in the past 3 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional and culinary interventionParticipants will attend 6 two-hours nutritional-culinary workshops between May 2022 and February 2023. All of the workshops will be held in a kitchen, and will be given in groups of 2 dyads or parents according to the intervention group. In addition, during the intervention families will be given access to a web page with nutrition and culinary education materials (infographics, videos). | Behavioural | Family intervention group, Parent-only intervention group |
| Nutritional interventionParticipants will attend 6 1-hour nutritional workshops between May 2022 and February 2023. The workshops will be held in person, and will be given in groups of 10-12 families. In addition, during the intervention families will be given access to a web page with nutrition education materials (infographics, videos). | Behavioural | Control |
Primary outcome
Effect of the intervention on changes in body mass index (BMI)
Time frame: At baseline, and 10 and 14 months follow-up
Weight will be measured with a Tanita RD-545 (Tanita Corp Tokyo Japan). Height will be measured to the nearest 0.1 cm using a portable stadiometer. Differences between intervention groups on changes on BMI between baseline and 10-months and baseline and 14-months follow up.
3 secondary outcomes
Effect of the intervention on home cooking habits
Time frame: At baseline, and 10 and 14 months follow-up
Effect of the intervention on the adherence to the Mediterranean Diet (MedDiet)
Time frame: At baseline, and 10 and 14 months follow-up
Home cooking attitudes and self-confidence on cooking at home with the cooking attitudes and self-confidence questionnaire
Time frame: At baseline, and 10 and 14 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 32521815Enright G, Allman-Farinelli M, Redfern J. Effectiveness of Family-Based Behavior Change Interventions on Obesity-Related Behavior Change in Children: A Realist Synthesis. Int J Environ Res Public Health. 2020 Jun 8;17(11):4099. doi: 10.3390/ijerph17114099.
- Background: PubMed 25263212Smith JD, Montano Z, Dishion TJ, Shaw DS, Wilson MN. Preventing weight gain and obesity: indirect effects of the family check-up in early childhood. Prev Sci. 2015 Apr;16(3):408-19. doi: 10.1007/s11121-014-0505-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional and culinary intervention and Nutritional intervention in people with Family Research, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the intervention on changes in body mass index (BMI) (time frame: At baseline, and 10 and 14 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280652, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.