An observational study in Dietary Habits, Parents and Diabetes Mellitus, Type 1, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
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?
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.
218 studies on the registry are indexed under Feeding Behavior; 95 are open to participants now.
This study's planned enrollment of 26 is below the median of 145 across 54 observational studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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).
Time frame: 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).
Time frame: 1 year
Food frequency estimation (half time)
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).
Time frame: 6 months
Adherence to Mediterranean Diet (predimed) (half time)
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).
Time frame: 6 months
Physical activity characterization
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).
Time frame: 6 and 12 months
Emotional stress characterization
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).
Time frame: 6 and 12 months
Emotional impact of the diagnosis characterization
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).
Time frame: 6 and 12 months
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau