Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Location status: Recruiting
NCT Number: NCT07142681
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?
Interested in participating?
Request Info18 year and older
All sexes
Observational
Barcelona, 08041, Spain
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
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).
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).
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).
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).
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).
Contact information is provided by the study sponsor or research team.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Other
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
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.
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