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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07142681
Enrollment
26
Registered
2025-08-27
Start date
2024-05-29
Completion date
2027-05-31
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Dietary Habits, Parents

Keywords

diet, dietary habits, nutritional intervention, Diabetes Mellitus, Type 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?

Detailed description

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.

Interventions

None listed

Sponsors

Hospital Sant Joan de Deu
CollaboratorOTHER
Hospital Arnau de Vilanova
CollaboratorOTHER
Fundació Institut de Recerca del Hospital Santa Creu i Sant Pau
CollaboratorUNKNOWN
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Food frequency estimation1 yearFood 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 yearPredimed 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

MeasureTime frameDescription
Food frequency estimation (half time)6 monthsFood 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).
Adherence to Mediterranean Diet (predimed) (half time)6 monthsPredimed 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).
Physical activity characterization6 and 12 monthsEvaluate 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).
Emotional stress characterization6 and 12 monthsEvaluate 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).
Emotional impact of the diagnosis characterization6 and 12 monthsEvaluate 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).

Countries

Spain

Contacts

Primary ContactJoana Rossell
joanarossell@gmail.com+34680264104

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026