An interventional study of KIDMED in Prediabetic State, sponsored by Pilar Aparicio Martinez. Completed at 1 site in Spain. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Pilar Aparicio Martinez · Not applicable, Interventional, and Prevention
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).
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 254 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →This is the only study on the registry with Pilar Aparicio Martinez as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children with a prediabetic status that followed up the sessions without nutritional intervention by a health care professional
Other: KIDMED
Pre-and post-intervention evaluation of the adherence to the Mediterranean diet and its effect on prediabetic state, as well as, other anthropometric values.
HbA1c levels
The HbA1c were measured at the initial visit (V0) and during the last visit (V4)
Time frame: Up to six months
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: Up to six months
Plan to share: Undecided — We have decided to first present the data in different forums and journals before making the database available
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.