Child, OnlyEsNuPINCT03941392
Nutritional Study in Spanish Pediatric Population
An observational study of Child, Only and Metabolic Diseases, run by Fundacion Iberoamericana de Nutricion at 1 site in Spain.
Trial summary
This study investigates the aspects related to the intake of food and nutrients, physical activity and sedentary behavior of Spanish children from 1 to 9 years. Furthermore, the investigators will know if the consumption of dairy products is associated with a better dietary pattern. Read more about this study
- Who is it for?
- Ages 1 year to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Metabolic Diseases, Child Development
- How many people
- 1,500 participants
- Where
- 1 siteSpain
- Study dates
- 2 Oct 2018to 31 Aug 2019
- Phase
- Observational
- 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 1 year to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Apparently healthy children between 1 to 9 years who live in an urban area with more than 50 000 inhabitants in Spain and that answer all the study recalls
Who may be able to join
- Healthy participants between 1 and 9 years old without diseases carrying changes in the dietary patterns.
- Those following dietary advice such as for prevention of non-communicable chronic diseases
Who cannot join
- Children with any disease that cause changes in the dietary pattern and with any dietary restriction.
- Children suffering a metabolic disease such as hyperthyroidism or hypothyroidism.
- Children diagnosed with allergy and/or food intolerance like dairy allergy, milk allergy, lactose intolerance or cows milk protein allergy.
- Children with any chronic disease that causes changes in the dietary pattern
- Children who live in an institution (colleges, nursing homes, hospitals, host Institutions, etc )
- Children with a transitory pathology (flu, gastroenteritis, chicken pox, etc) at the time of the fieldwork.
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- Children following a therapeutic diet due to recent surgery or any other medical prescription.
- Children related to Lactalis or Madison MK employees.
- Children whose parents or caregivers did not provide a signed consent form for their participation or not completed any study phase.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Study in Spanish Pediatric Population (EsNuPI)
This study investigates the aspects related to the intake of food and nutrients, physical activity and sedentary behavior of Spanish children from 1 to 9 years. Furthermore, the investigators will know if the consumption of dairy products is associated with a better dietary pattern.
Hypothesis: The habitual consumption of dairy products as part of a regular diet is associated with a better dietary pattern and a higher global diet quality.
Read the detailed description
A prospective cross-sectional observational study in 1500 Spanish children (1 to 9 years) in urban areas >50,0000 inhabitants, distributed in eight regions (according to Nielsen Spanish areas) aiming to evaluate the food habits, dietary patterns, and nutrient intake, as well as physical activity behaviors.
- Conditions
- Child, Only, Metabolic Diseases, Child Development, Diet Habit, Healthy Diet, Feeding Behavior
- Keywords
- Nutrition, Pediatric age, Physical activity, Dairy products, Dairy consumption, Sedentary habits, Diet quality, Children
- Medical subject headings
- Metabolic Diseases, Feeding Behavior, Health Behavior, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children between 1 and 9 years old | A sample of 1500 apparently healthy children between 1 to 9 years old from urban areas from different regions of Spain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary habits
Dietary diversity and variety determinated by using a FFQ from last year of consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month
Measured: 10 months
Food
Food groups will be obtained from the FFQ of last year's consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month. The food based dietary guidelines from Spain will be used to determine the number of portions consumed per food group.
Measured: 10 months
Beverages
Beverage groups will be obtained from the FFQ of last year's consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month. The food based dietary guidelines from Spain will be used to determine the number of portions consumed per beverage group.
Measured: 10 months
Energy, macro and micronutrient composition of the diet
Energy, macro and micronutrient composition of the diet determined by 2 24-h recalls
Measured: 10 months
Active and sedentary habits
Active and sedentary habits were measured with the 1-week activity recall validated in children
Measured: 10 months
Milk and dairy products consumption
Evaluate the different types of milk that children drink in 24 h, twice through 24 h dietary
Measured: 10 months
Dietary quality index for children "KidMed"
Evaluate the quality of the diet through this quality index for the specific age group
Measured: 10 months
Secondary outcomes (2)
Growth and BMI
Determined by reported age, weight (kg), and height (cm)
Measured: 1 year
Goldberg & Black cut-off for Energy Intake: Plausibility of the reported energy intake
Measured by the relation between the reported energy intake and the estimated energy expenditure. The cut-off points are determined by the information reported by the population itself.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start2 Oct 2018
- Primary completion28 Feb 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Iberoamericana de Nutricion
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada, Fundación Española de la Nutrición, CEU San Pablo University, Lactalis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941392
- Sponsor's protocol ID
- FF01/2019
- Acronym
- EsNuPI
- Status last verified
- Feb 2020
- First submitted
- 22 Apr 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Study in Spanish Pediatric Population (EsNuPI)
- ClinicalTrials.gov ID
- NCT03941392
- Acronym / sponsor ID
- EsNuPI / FF01/2019
- Conditions
- Child, Only, Metabolic Diseases, Child Development, Diet Habit, Healthy Diet, Feeding Behavior
- Keywords
- Nutrition, Pediatric age, Physical activity, Dairy products, Dairy consumption, Sedentary habits, Diet quality, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Fundacion Iberoamericana de NutricionUniversity, hospital or other
- Collaborators
- Universidad de Granada, Fundación Española de la Nutrición, CEU San Pablo University, Lactalis
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 8 May 2019 (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.
This study investigates the aspects related to the intake of food and nutrients, physical activity and sedentary behavior of Spanish children from 1 to 9 years. Furthermore, the investigators will know if the consumption of dairy products is associated with a better dietary pattern.
Hypothesis: The habitual consumption of dairy products as part of a regular diet is associated with a better dietary pattern and a higher global diet quality.
Detailed description
A prospective cross-sectional observational study in 1500 Spanish children (1 to 9 years) in urban areas >50,0000 inhabitants, distributed in eight regions (according to Nielsen Spanish areas) aiming to evaluate the food habits, dietary patterns, and nutrient intake, as well as physical activity behaviors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy children between 1 and 9 years old | – | –A sample of 1500 apparently healthy children between 1 to 9 years old from urban areas from different regions of Spain. |
Who may qualify
- Ages
- 1 year to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Apparently healthy children between 1 to 9 years who live in an urban area with more than 50 000 inhabitants in Spain and that answer all the study recalls
Key inclusion criteria (2 listed)
- Healthy participants between 1 and 9 years old without diseases carrying changes in the dietary patterns.
- Those following dietary advice such as for prevention of non-communicable chronic diseases
Key exclusion criteria (9 listed)
- Children with any disease that cause changes in the dietary pattern and with any dietary restriction.
- Children suffering a metabolic disease such as hyperthyroidism or hypothyroidism.
- Children diagnosed with allergy and/or food intolerance like dairy allergy, milk allergy, lactose intolerance or cows milk protein allergy.
- Children with any chronic disease that causes changes in the dietary pattern
- Children who live in an institution (colleges, nursing homes, hospitals, host Institutions, etc )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dietary habits
Time frame: 10 months
Dietary diversity and variety determinated by using a FFQ from last year of consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month
Food
Time frame: 10 months
Food groups will be obtained from the FFQ of last year's consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month. The food based dietary guidelines from Spain will be used to determine the number of portions consumed per food group.
Beverages
Time frame: 10 months
Beverage groups will be obtained from the FFQ of last year's consumption, the FFQ consisted of 150 food items commonly used in the local Spanish cuisine. The FFQ asked about consumption of foods and beverages in portions per day, week or month. The food based dietary guidelines from Spain will be used to determine the number of portions consumed per beverage group.
Energy, macro and micronutrient composition of the diet
Time frame: 10 months
Energy, macro and micronutrient composition of the diet determined by 2 24-h recalls
Active and sedentary habits
Time frame: 10 months
Active and sedentary habits were measured with the 1-week activity recall validated in children
Milk and dairy products consumption
Time frame: 10 months
Evaluate the different types of milk that children drink in 24 h, twice through 24 h dietary
Dietary quality index for children "KidMed"
Time frame: 10 months
Evaluate the quality of the diet through this quality index for the specific age group
2 secondary outcomes
Growth and BMI
Time frame: 1 year
Goldberg & Black cut-off for Energy Intake: Plausibility of the reported energy intake
Time frame: 1 year
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child, Only and Metabolic Diseases, run by Fundacion Iberoamericana de Nutricion at 1 site 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 2 inclusion and 9 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Dietary habits (time frame: 10 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.