Changes in the Dietary Patterns of Adults in Care of a Newly Diagnosed Type 1 Diabetes Mellitus Child

NCT07142681 | Recruiting

• 1 other identifier: IIBSP-DDM-2023-166
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Dietary Habits; Parents; Diabetes Mellitus, Type 1

Keywords

diet; dietary habits; nutritional intervention; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Food frequency estimation

  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).

  1 year

• Adherence to Mediterranean Diet (Predimed questionnaire)

  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).

  1 year

Secondary Outcomes (5)

• Food frequency estimation (half time)

  6 months

• Adherence to Mediterranean Diet (predimed) (half time)

  6 months

• Physical activity characterization

  6 and 12 months

• Emotional stress characterization

  6 and 12 months

• Emotional impact of the diagnosis characterization

  6 and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents of infants with recently diagnosed type 1 diabetes mellitus, that live most of the time with the infant, and are responsible for the household meals.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Hospital Sant Joan de Deu: collaborator
• Hospital Arnau de Vilanova: collaborator
• Fundació Institut de Recerca del Hospital Santa Creu i Sant Pau: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

MeSH Terms

Conditions

Feeding Behavior; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Joana Rossell

CONTACT

+34680264104; joanarossell@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postdoctoral researcher

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 27, 2025
• Study Start: May 29, 2024
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

ES (1)