Prediabetic StateINTKIDMEDPREDNCT05424107
A Mediterranean Intervention on Prediabetic Children
A study testing KIDMED in people with Prediabetic State, run by Pilar Aparicio Martinez at 1 site in Spain.
Trial summary
Prediabetes is a pathological condition where the blood glucose concentration is higher than normal concentrations but lower than those considered in type 2 diabetes mellitus (DM2) diagnosis. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- KIDMED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteSpain
- Study dates
- 4 Sep 2018to 10 Jun 2022
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presence of HbA1c levels between 5.7 and 6.4% in the blood tests
- Signed informed consent by the minor
- Signed informed consent by the minor's parents or guardians.
Who cannot join
- Presence of HbA1c levels below 5.7%
- Presence of HbA1c levels above 6.4%
- Presence of pathological metabolic diseases, such as diabetes or metabolic syndrome
- Lack of the signed informed consent by the minor and legal guardian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Status of South Spanish Children: A Mediterranean Diet Nutritional Intervention of Children With Insulin Resistance From a Rural Area
Prediabetes is a pathological condition where the blood glucose concentration is higher than normal concentrations but lower than those considered in type 2 diabetes mellitus (DM2) diagnosis. Until a few years ago, this prediabetes occurred in adults with associated risk factors such as being overweight or obese, sedentary lifestyle, poor eating habits, and cardiovascular problems, among others. Recently, it has begun to be detected in children, with family eating habits becoming more critical. Therefore, the objectives of this study were to determine the efficacy of the nutritional intervention in children with analytical data on pre-diabetes; and the secondary ones proposed were to evaluate if an individualized and directed nutritional intervention compared to the standardized one supposes an improvement in children's dietary habits and to determine if nutritional education improves anthropometric parameters and adherence to a Mediterranean diet, through the evaluation of the Mediterranean Diet Quality Index (KIDMED).
- Conditions
- Prediabetic State
- Being tested
- KIDMED
- Keywords
- Nutritional intervention, Prediabetes, Children, Mediterranean diet
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIDMEDOther
Pre-and post-intervention evaluation of the adherence to the Mediterranean diet and its effect on prediabetic state, as well as, other anthropometric values.
| Study group | Role | What they receive |
|---|---|---|
| Non-nutritional intervention | Experimental | Children with a prediabetic status that followed up the sessions without nutritional intervention by a health care professional Receives: Other: KIDMED |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c levels
The HbA1c were measured at the initial visit (V0) and during the last visit (V4)
Measured: Up to six months
Secondary outcomes (9)
Height (m2)
The height of the children was measured via the Omron BF-511 impedance mete, being classified to Melo Sailor's tables of child growth. The measure of the impedance was taken at the initial visit (V0) and at the last visit (V4)
Measured: Up to six months
Weight (kg)
The weight (kg) of the children was measured via the Omron BF-511 impedance mete, being classified to Melo Sailor's tables of child growth. The measure of the impedance was taken at the initial visit (V0) and at the last visit (V4)
Measured: Up to six months
Waist circumference (cm)
The waist circumference (cm) of the children was measured via an inextensible measuring tape at the initial visit (V0) and at the last visit (V4)
Measured: Up to six months
Hip circumference(cm)
The hip circumference(cm) of the children was measured via an inextensible measuring tape at the initial visit (V0) and at the last visit (V4)
Measured: Up to six months
Arm circumference (cm)
The arm circumference (cm) of the children was measured via an inextensible measuring tape at the initial visit (V0) and at the last visit (V4). The measurement follows the recommendations of the International Standards for Anthropometric Assessment
Measured: Up to six months
Body mass index (kg/m2)
The children's body mass index (kg/m2) was obtained following the World Health Organization's recommendations and guidelines, being classified to Melo Sailor's tables of child growth. The calculation of the BMI was obtained at the initial visit (V0) and the last visit (V4)
Measured: Up to six months
Validated nutritional assessment questionnaire: adherence to the Mediterranean diet (KIDMED)
The KIDMED was used to determine adherence to the change in diet from the initial visit (V0) and the final visit (V4). This questionnaire is formed by 16 questions related to adherence to the Mediterranean diet, in addition to 7 items complementary to the test. All questions were answered positively or negatively. Of the 16 main questions, questions number 6, 11, 14, and 16, in their affirmative answers had a negative meaning, so they were worth (-1), on the other hand, the remaining questions whose affirmative answers represented a positive value concerning the Mediterranean diet were scored with (+1). Negative responses do not score (0). According to the test, the results are grouped into different levels of adherence to the Mediterranean diet, low (score 0 to 3), medium (score 4-7), and high (8 to 12).
Measured: Up to six months
The Food Frequency Questionnaire (FFQ)
The Food Frequency Questionnaire (FFQ) was used to determine the consumption of food and the change in diet from the initial visit (V0) and the final visit (V4). The Food Frequency Questionnaire (FFQ) includes 137 foods classified into 14 food groups (dairy products, eggs, meat or meat products, fish or shellfish, vegetables, potatoes, fruits, nuts, legumes, cereals, olive oil, pastries, cakes or sweets, and alcoholic beverages). Frequencies are recorded using a 9-category Likert-type scale (from "rarely" to "6 or more times per day"). In addition, the consumption of common foods in this population group was collected, such as juices (nectars, concentrates, etc.), sweets or sugary breakfast cereals (with chocolate, honey, etc.), and the techniques habitual culinary used in the houses. Energy and nutrient intakes were calculated using Spanish food composition tables
Measured: Up to six months
Decalogue of healthy eating
The decalogue of healthy eating was used to analyze the healthy eating habits and the change in diet from the initial visit (V0) and the final visit (V4). This survey was developed for the internal control of adherence to the prescribed dietary recommendations, is a tool that has allowed the dietitian and the children/parents to know which were the dietary aspects to improve quickly and simple; according to the test it was grouped into different levels of adherence to the diet, low (score 0 to 3), medium (score 4-7) and high (8 to 10).
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start4 Sep 2018
- Primary completion4 Jan 2020
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a study with pre-and post-intervention evaluation, randomized intervention in parallel groups EG and CG, in schoolchildren with analytical data of pre-diabetes. The study design was divided into two phases. In each phase, a follow-up was carried out with five visits, from the initial visit (v0) to the final visit (v4).
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pilar Aparicio Martinez
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)
- Responsible party
- Sponsor-investigator, Pilar Aparicio Martinez, Universidad de Córdoba
- Investigators
- Francisco Javier Fonseca del Pozo, PhD, Principal investigator, Maimónides Biomedical Research Institute of Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424107
- Sponsor's protocol ID
- 2353
- Other IDs
- 251
- Acronym
- INTKIDMEDPRED
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have decided to first present the data in different forums and journals before making the database available
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status of South Spanish Children: A Mediterranean Diet Nutritional Intervention of Children With Insulin Resistance From a Rural Area
- ClinicalTrials.gov ID
- NCT05424107
- Acronym / sponsor ID
- INTKIDMEDPRED / 2353
- Conditions
- Prediabetic State
- Keywords
- Nutritional intervention, Prediabetes, Children, Mediterranean diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Pilar Aparicio MartinezUniversity, hospital or other
- Collaborators
- Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 4 Jan 2020 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 21 Jun 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.
Prediabetes is a pathological condition where the blood glucose concentration is higher than normal concentrations but lower than those considered in type 2 diabetes mellitus (DM2) diagnosis. Until a few years ago, this prediabetes occurred in adults with associated risk factors such as being overweight or obese, sedentary lifestyle, poor eating habits, and cardiovascular problems, among others. Recently, it has begun to be detected in children, with family eating habits becoming more critical. Therefore, the objectives of this study were to determine the efficacy of the nutritional intervention in children with analytical data on pre-diabetes; and the secondary ones proposed were to evaluate if an individualized and directed nutritional intervention compared to the standardized one supposes an improvement in children's dietary habits and to determine if nutritional education improves anthropometric parameters and adherence to a Mediterranean diet, through the evaluation of the Mediterranean Diet Quality Index (KIDMED).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a study with pre-and post-intervention evaluation, randomized intervention in parallel groups EG and CG, in schoolchildren with analytical data of pre-diabetes. The study design was divided into two phases. In each phase, a follow-up was carried out with five visits, from the initial visit (v0) to the final visit (v4).
| Arm | Type | Receives |
|---|---|---|
| Non-nutritional intervention | Experimental | Other: KIDMEDChildren with a prediabetic status that followed up the sessions without nutritional intervention by a health care professional |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Presence of HbA1c levels between 5.7 and 6.4% in the blood tests
- Signed informed consent by the minor
- Signed informed consent by the minor's parents or guardians.
Key exclusion criteria (4 listed)
- Presence of HbA1c levels below 5.7%
- Presence of HbA1c levels above 6.4%
- Presence of pathological metabolic diseases, such as diabetes or metabolic syndrome
- Lack of the signed informed consent by the minor and legal guardian
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 |
|---|---|---|
| KIDMEDPre-and post-intervention evaluation of the adherence to the Mediterranean diet and its effect on prediabetic state, as well as, other anthropometric values. | Other | Non-nutritional intervention |
Primary outcome
HbA1c levels
Time frame: Up to six months
The HbA1c were measured at the initial visit (V0) and during the last visit (V4)
9 secondary outcomes
Height (m2)
Time frame: Up to six months
Weight (kg)
Time frame: Up to six months
Waist circumference (cm)
Time frame: Up to six months
Hip circumference(cm)
Time frame: Up to six months
Arm circumference (cm)
Time frame: Up to six months
Body mass index (kg/m2)
Time frame: Up to six months
Validated nutritional assessment questionnaire: adherence to the Mediterranean diet (KIDMED)
Time frame: Up to six months
The Food Frequency Questionnaire (FFQ)
Time frame: Up to six months
Decalogue of healthy eating
Time frame: Up to six months
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 21 Jun 2022.
- Individual participant dataSharing planned: Undecided. We have decided to first present the data in different forums and journals before making the database available
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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.
Francisco Javier Fonseca del Pozo, PhD principal investigator
Maimónides Biomedical Research Institute of Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KIDMED in people with Prediabetic State, run by Pilar Aparicio Martinez 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 3 inclusion and 4 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 21 Jun 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?
HbA1c levels (time frame: Up to six months). 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 21 Jun 2022.