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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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