Clinical Trials in Spain / NCT07142681
Recruiting
Observational
Changes in the Dietary Patterns of Adults in Care of a Newly Diagnosed Type 1 Diabetes Mellitus Child
NCT07142681 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Dietary HabitsParentsDiabetes Mellitus, Type 1
Study summary
The goal of this observational study is to compare the feeding pattern evolution in parents whose children have been newly diagnosed with type 1 diabetes mellitus, versus one year later. The main question it aims to answer is:
\- Does the dietary intervention in the pediatric population affect the parent's diet?
Eligibility
Inclusion Criteria:
* Over 18 years old
* Parents or legal tutors of a child with type 1 diabetes (according to ADA criteria).
* Less than 1 week since the type 1 diabetes diagnostic.
* Living together more than 40%of the time with the infant with type 1 diabetes.
* Be the adult responsible for most of the family meals.
Exclusion Criteria:
* Parents of infants with other types of diabetes (type 2, MODY, gestational, others).
* Household members with diseases or conditions that can affect dietary habits (type 2 diabetes, kidney disease, pregnancies).
* Significant dietary habit modifications (change to a vegeterian, vegan, palea, or other diets, fasting situations) in the last month prior to the diagnosis of type 1 diabetes.
Primary outcome measure(s)
- Food frequency estimation — 1 year
Food and beverage consumption are evaluated with the deliverance of a Food Frequency Questionnaire tool - the Cuestionario de Frecuencia de Consumo de Alimentos (CFCA) - with 137 items and validated for the spanish population. A copy of the CFCA in english is attached in the protocol. Changes in portions, food items, and frequency can be estimated through the comparison of the questionnaire at basal and half time. The questionnaire evaluated will be the ones handled at the start and at the end of the study (0 and 12 months). - Adherence to Mediterranean Diet (Predimed questionnaire) — 1 year
Predimed questionnaire, with 14 items and a punctuation associated to each answer answer, allowes the obtantion of a score. Obtaining a score of less than 9 indicates a poor adherence to the mediterranean diet, and obtaining a score of 9 or more indicates a good adherence to the mediterranean diet. English version: http://www.predimed.es/uploads/8/0/5/1/8051451/p14\_meddiet\_english\_version.png The questionnaire evaluated will be the ones handled at the start and at the end of the study (0 and 12 months).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07142681 on ClinicalTrials.gov ↗ ← All trials in Spain