Feeding and Eating Disorders of ChildhoodNCT04301180
Quality of Diet in Preschool Population
A study testing Education food in people with Feeding and Eating Disorders of Childhood, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial summary
Childhood obesity is a problem of high prevalence and repercussions in adulthood. It is mostly due to inadequate life habits, modifiable through preventive strategies. The objective was to evaluate in the medium term the effectiveness of an intervention on adherence to the Mediterranean diet pattern in preschoolers. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding and Eating Disorders of Childhood
- What is being tested?
- Education food
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2017to 1 Sep 2020
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 3 and 5 years
- Oral comprehension of Spanish.
Who cannot join
- Existence of language barriers in parents defined as not understanding spoken or written Spanish.
- Treatment with glucocorticoids.
- Having chronic diseases that could interfere with somatometry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Multicompetent Intervention on the Quality of the Diet in the Preschool Population
Childhood obesity is a problem of high prevalence and repercussions in adulthood. It is mostly due to inadequate life habits, modifiable through preventive strategies. The objective was to evaluate in the medium term the effectiveness of an intervention on adherence to the Mediterranean diet pattern in preschoolers.
Method: Community trial with two groups, in children between 3-5 years. The experimental group conducted a school garden and the usual contents on human body and health were taught in the control. Two schools were selected by cluster sampling, whose first unit of randomization were the educational areas followed by schools. The adaptation to the Mediterranean diet pattern was evaluated using the KIDMED questionnaire and weight, height, BMI and sociodemographic variables were controlled.
- Being tested
- Education food
- Keywords
- Nutritional Status, Child Nutrition Sciences, Nutrition Therapy, Nutrition Assessment, Diet, Food, and Nutrition
- Medical subject headings
- Feeding and Eating Disorders of Childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education foodDevice
The intervention consisted of the presentation of food education content while conducting an orchard with seasonal vegetables
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group conducted 10 weekly sessions, with an approximate duration of 45 minutes per session, which consisted of the presentation of food education content while conducting an orchard with seasonal vegetables. Simple recipes were also described in which these vegetables were included to be made at home, along with information on children's books that dealt with the topic of food and were available in the public library.
All children in the experimental groups were given written instructions so that they could perform at their home, together with their parents, the manipulative activities suggested each week. All these contents were common for all the participants in the study. Session material was renewed weekly. Receives: Device: Education food |
| Control | No intervention | The control group received the usual training corresponding to the contents of the "human body" module that is currently taught in each center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of KIDMED questionnaire
Mediterranean diet adherence assessment questionnaire, 16 items, scored of 1 point per item, minimun 0 points (worse) to 16 points (better).
Measured: During the procedure; baseline, 1 year and 2 years
Secondary outcomes (5)
Change of Weight
Changes of Weight in kilograms (Kg), were collected in children using approved scale at baseline, al 1 year and 2 years.
Measured: During the procedure; baseline, 1 year and 2 years
Educational level of parents
A survey will assess the level of education of parents; primary, secondary, university or without education, expressed in %.
Measured: Baseline
Employment status of parents
The parents' purchasing level will be evaluated in percentages (%); low, medium and high employement status.
Measured: Baseline
Change of Height
Changes of Height in meters, were collected in children using approved scale at baseline, al 1 year and 2 years.
Measured: During the procedure; baseline, 1 year and 2 years
Change of BMI (body mass index)
Change of weight and height outcomes will be combined to report BMI in kg/m^2, upper 20 is considered obesity.
Measured: During the procedure; baseline, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Apr 2017
- Primary completion1 Apr 2017
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating Disorders of ChildhoodStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group conducted 10 weekly sessions, with an approximate duration of 45 minutes per session, which consisted of the presentation of food education content while conducting an orchard with seasonal vegetables. Simple recipes were also described in which these vegetables were included to be made at home, along with information from children's books that dealt with the topic of food and were available in the public library. The control group received the usual training corresponding to the contents of the "human body" module that is currently taught in each center. All children in the experimental groups were given written instructions so that they could perform at their home, together with their parents, the manipulative activities suggested each week. All these contents were common for all the participants in the study.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Collaborators
- David Varillas Delgado, María Cristina Martincrespo-Blanco, Saray Blanco-Abril, María Gema Cid-Expósito, Juana Robledo-Martín
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301180
- Sponsor's protocol ID
- CEIC 2016/013
- Status last verified
- Aug 2021
- First submitted
- 29 Feb 2020
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multicompetent Intervention on the Quality of the Diet in the Preschool Population
- ClinicalTrials.gov ID
- NCT04301180
- Acronym / sponsor ID
- CEIC 2016/013
- Keywords
- Nutritional Status, Child Nutrition Sciences, Nutrition Therapy, Nutrition Assessment, Diet, Food, and Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Collaborators
- David Varillas Delgado, María Cristina Martincrespo-Blanco, Saray Blanco-Abril, María Gema Cid-Expósito, Juana Robledo-Martín
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 10 Mar 2020 (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.
Childhood obesity is a problem of high prevalence and repercussions in adulthood. It is mostly due to inadequate life habits, modifiable through preventive strategies. The objective was to evaluate in the medium term the effectiveness of an intervention on adherence to the Mediterranean diet pattern in preschoolers.
Method: Community trial with two groups, in children between 3-5 years. The experimental group conducted a school garden and the usual contents on human body and health were taught in the control. Two schools were selected by cluster sampling, whose first unit of randomization were the educational areas followed by schools. The adaptation to the Mediterranean diet pattern was evaluated using the KIDMED questionnaire and weight, height, BMI and sociodemographic variables were controlled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group conducted 10 weekly sessions, with an approximate duration of 45 minutes per session, which consisted of the presentation of food education content while conducting an orchard with seasonal vegetables. Simple recipes were also described in which these vegetables were included to be made at home, along with information from children's books that dealt with the topic of food and were available in the public library. The control group received the usual training corresponding to the contents of the "human body" module that is currently taught in each center. All children in the experimental groups were given written instructions so that they could perform at their home, together with their parents, the manipulative activities suggested each week. All these contents were common for all the participants in the study.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Education foodThe experimental group conducted 10 weekly sessions, with an approximate duration of 45 minutes per session, which consisted of the presentation of food education content while conducting an orchard with seasonal vegetables. Simple recipes were also described in which these vegetables were included to be made at home, along with information on children's books that dealt with the topic of food and were available in the public library. All children in the experimental groups were given written instructions so that they could perform at their home, together with their parents, the manipulative activities suggested each week. All these contents were common for all the participants in the study. Session material was renewed weekly. |
| Control | No intervention | –The control group received the usual training corresponding to the contents of the "human body" module that is currently taught in each center. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 3 and 5 years
- Oral comprehension of Spanish.
Key exclusion criteria (3 listed)
- Existence of language barriers in parents defined as not understanding spoken or written Spanish.
- Treatment with glucocorticoids.
- Having chronic diseases that could interfere with somatometry.
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 |
|---|---|---|
| Education foodThe intervention consisted of the presentation of food education content while conducting an orchard with seasonal vegetables | Device | Experimental |
Primary outcome
Change of KIDMED questionnaire
Time frame: During the procedure; baseline, 1 year and 2 years
Mediterranean diet adherence assessment questionnaire, 16 items, scored of 1 point per item, minimun 0 points (worse) to 16 points (better).
5 secondary outcomes
Change of Weight
Time frame: During the procedure; baseline, 1 year and 2 years
Educational level of parents
Time frame: Baseline
Employment status of parents
Time frame: Baseline
Change of Height
Time frame: During the procedure; baseline, 1 year and 2 years
Change of BMI (body mass index)
Time frame: During the procedure; baseline, 1 year and 2 years
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 Jan 2022.
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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?
A study testing Education food in people with Feeding and Eating Disorders of Childhood, run by Universidad Francisco de Vitoria 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 3 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 Jan 2022. 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?
Change of KIDMED questionnaire (time frame: During the procedure; baseline, 1 year and 2 years). 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 Jan 2022.