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A Mediterranean Intervention on Prediabetic Children (INTKIDMEDPRED)

Primary Purpose

Prediabetic State

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
KIDMED
Sponsored by
Pilar Aparicio Martinez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State focused on measuring Nutritional intervention, Prediabetes, Children, Mediterranean diet

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ayuntamiento de Pedra Abad

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-nutritional intervention

Arm Description

Children with a prediabetic status that followed up the sessions without nutritional intervention by a health care professional

Outcomes

Primary Outcome Measures

HbA1c levels
The HbA1c were measured at the initial visit (V0) and during the last visit (V4)

Secondary Outcome Measures

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)
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)
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)
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)
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
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)
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).
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
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).

Full Information

First Posted
June 9, 2022
Last Updated
June 14, 2022
Sponsor
Pilar Aparicio Martinez
Collaborators
Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)
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1. Study Identification

Unique Protocol Identification Number
NCT05424107
Brief Title
A Mediterranean Intervention on Prediabetic Children
Acronym
INTKIDMEDPRED
Official Title
Nutritional Status of South Spanish Children: A Mediterranean Diet Nutritional Intervention of Children With Insulin Resistance From a Rural Area
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
January 4, 2020 (Actual)
Study Completion Date
June 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pilar Aparicio Martinez
Collaborators
Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
Nutritional intervention, Prediabetes, Children, Mediterranean diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-nutritional intervention
Arm Type
Experimental
Arm Description
Children with a prediabetic status that followed up the sessions without nutritional intervention by a health care professional
Intervention Type
Other
Intervention Name(s)
KIDMED
Intervention Description
Pre-and post-intervention evaluation of the adherence to the Mediterranean diet and its effect on prediabetic state, as well as, other anthropometric values.
Primary Outcome Measure Information:
Title
HbA1c levels
Description
The HbA1c were measured at the initial visit (V0) and during the last visit (V4)
Time Frame
Up to six months
Secondary Outcome Measure Information:
Title
Height (m2)
Description
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)
Time Frame
Up to six months
Title
Weight (kg)
Description
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)
Time Frame
Up to six months
Title
Waist circumference (cm)
Description
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)
Time Frame
Up to six months
Title
Hip circumference(cm)
Description
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)
Time Frame
Up to six months
Title
Arm circumference (cm)
Description
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
Time Frame
Up to six months
Title
Body mass index (kg/m2)
Description
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)
Time Frame
Up to six months
Title
Validated nutritional assessment questionnaire: adherence to the Mediterranean diet (KIDMED)
Description
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).
Time Frame
Up to six months
Title
The Food Frequency Questionnaire (FFQ)
Description
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
Time Frame
Up to six months
Title
Decalogue of healthy eating
Description
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).
Time Frame
Up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Fonseca del Pozo, PhD
Organizational Affiliation
Maimónides Biomedical Research Institute of Córdoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayuntamiento de Pedra Abad
City
Córdoba
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We have decided to first present the data in different forums and journals before making the database available

Learn more about this trial

A Mediterranean Intervention on Prediabetic Children

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