- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05424107
A Mediterranean Intervention on Prediabetic Children (INTKIDMEDPRED)
June 14, 2022 updated by: Pilar Aparicio Martinez
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
254
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Córdoba, Spain
- Ayuntamiento de Pedra Abad
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Non-nutritional intervention
Children with a prediabetic status that followed up the sessions without nutritional intervention by a health care professional
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Pre-and post-intervention evaluation of the adherence to the Mediterranean diet and its effect on prediabetic state, as well as, other anthropometric values.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c levels
Time Frame: Up to six months
|
The HbA1c were measured at the initial visit (V0) and during the last visit (V4)
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Up to six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Height (m2)
Time Frame: Up to six months
|
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)
|
Up to six months
|
Weight (kg)
Time Frame: Up to six months
|
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)
|
Up to six months
|
Waist circumference (cm)
Time Frame: Up to six months
|
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)
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Up to six months
|
Hip circumference(cm)
Time Frame: Up to six months
|
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)
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Up to six months
|
Arm circumference (cm)
Time Frame: Up to six months
|
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
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Up to six months
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Body mass index (kg/m2)
Time Frame: Up to six months
|
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)
|
Up to six months
|
Validated nutritional assessment questionnaire: adherence to the Mediterranean diet (KIDMED)
Time Frame: Up to six months
|
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).
|
Up to six months
|
The Food Frequency Questionnaire (FFQ)
Time Frame: Up to six months
|
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
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Up to six months
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Decalogue of healthy eating
Time Frame: Up to six months
|
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).
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Up to six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francisco Javier Fonseca del Pozo, PhD, Maimónides Biomedical Research Institute of Córdoba
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 4, 2018
Primary Completion (Actual)
January 4, 2020
Study Completion (Actual)
June 10, 2022
Study Registration Dates
First Submitted
June 9, 2022
First Submitted That Met QC Criteria
June 14, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Actual)
June 21, 2022
Last Update Submitted That Met QC Criteria
June 14, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2353
- 251 (PEIBA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
We have decided to first present the data in different forums and journals before making the database available
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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