About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
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).
Secondary outcomes
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).
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).
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).
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).
Sponsors and contacts
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead sponsor
Hospital Sant Joan de Deu
Collaborator
Hospital Arnau de Vilanova
Collaborator