Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07142681

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

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?

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location status: Recruiting

Location contact

Joana Rossell, PhD

CONTACT

[email protected]

680264104

About this study

Parents with newly diagnosed type 1 diabetes infant will be identified upon hospital admission.

Parents will be informed about the study and asked if they are willing to participate. If affirmative, the participant parent will sign the informed consent, and one of the investigators will hand over the different questionnaires. A brief physical exploration will be performed.

After one year, and coinciding with any programmed visit to the hospital, questionnaires will be handed over again, together with the repetition of the brief physical exploration.

The questonnairs include: Food register, Mediterranean adherence, physical activity, pediatric anxiety, and hospital anxiety and depression scale questionnaires.

Data will be extracted from the questionnaires, and analyzed.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Food frequency estimation

    Time frame: 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).

  2. Adherence to Mediterranean Diet (Predimed questionnaire)

    Time frame: 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).

Secondary outcomes

  1. Food frequency estimation (half time)

    Time frame: 6 months

    Food and beverage consumption are evaluated with the deliverance of a Food Frequency Questionnaire -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 half-time of the study (0 and 6 months).

  2. Adherence to Mediterranean Diet (predimed) (half time)

    Time frame: 6 months

    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 half-time of the study (0 and 6 months).

  3. Physical activity characterization

    Time frame: 6 and 12 months

    Evaluate the changes in the physyical activity during the first 6 months and the first year.

    Physical activity will be measured through the administration of the International Physical Activity Questionnaire (IPAQ). This questionnnaire contains 7 answers that gather information of vigourous and moderate activity, as well as walking. Each activity is multiplied by a standard unit for measuring energy expenditure (MET) which gives us information whether the physical activity of the subject is High, Moderate, or Low.

    The questionnaire will be handled at the start, half-time, and end of the study (0, 6, and 12 months).

  4. Emotional stress characterization

    Time frame: 6 and 12 months

    Evaluate the changes in the emotional stress felt by the parents during the first 6 months and the first year.

    This outcome will be measured through the administration of the Hospital Anxiety and Depression Scale (HADS), consisting of 14 items, 7 for anxiety measurement and 7 for depression measurement. Each item can score between 0 to 4 points, with a maximum score for each subscale: 21. The two subscales score independently: 0-7 is normal, 8-10 borderline abnormal (mild), and over 11 abnormal (clinical case).

    The questionnaire will be handled at the start, half-time, and end of the study (0, 6, and 12 months).

  5. Emotional impact of the diagnosis characterization

    Time frame: 6 and 12 months

    Evaluate the changes in anxiety and depression scale levels during the first 6 months and the first year.

    This outcome is measured through the administration of the validated Pediatric Inventory for Parents (PIP), used to measure parental stress related to caring for a child with a chronic illness. It evaluates both the frequency and the difficulty of stressors that parents experience through 42 items analyzing the frequency and the difficulty of an item. Each item can obtain a score between 0-5, and the final punctuation can range from 42 to 210, with higher punctuations indicating higher stress.

    The questionnaire will be handled at the start, half-time, and end of the study (0, 6, and 12 months).

Study contacts

Contact information is provided by the study sponsor or research team.

Joana Rossell

CONTACT

[email protected]

+34680264104

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Hospital Arnau de Vilanova
  • Hospital Sant Joan de Deu

Registry information

Official study title

Changes in the Dietary Patterns of Adults in Family Units With a Newly Diagnosed Type 1 Diabetes Mellitus Child: Impact of Educational Actions Derived From Standard Care

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.