Dietary HabitsNCT07142681
Changes in the Dietary Patterns of Adults in Care of a Newly Diagnosed Type 1 Diabetes Mellitus Child
An observational study of Dietary Habits and Parents, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dietary Habits, Parents, Diabetes Mellitus, Type 1
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 29 May 2024to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Joana Rossell, PhD, 680264104, jrossell@santpau.cat
About this study
Official title: 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
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?
Read the 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.
- Conditions
- Dietary Habits, Parents, Diabetes Mellitus, Type 1
- Keywords
- diet, dietary habits, nutritional intervention, Diabetes Mellitus, Type 1
- Medical subject headings
- Feeding Behavior, Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 1 year
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start29 May 2024
- Primary completion30 May 2025
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Hospital Arnau de Vilanova
- Responsible party
- Principal investigator, Joana Rossell, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142681
- Sponsor's protocol ID
- IIBSP-DDM-2023-166
- Status last verified
- Aug 2025
- First submitted
- 2 Jul 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07142681
- Acronym / sponsor ID
- IIBSP-DDM-2023-166
- Conditions
- Dietary Habits, Parents, Diabetes Mellitus, Type 1
- Keywords
- diet, dietary habits, nutritional intervention, Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, Hospital Arnau de Vilanova
- Study start
- 29 May 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Food frequency estimation
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).
Adherence to Mediterranean Diet (Predimed questionnaire)
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).
5 secondary outcomes
Food frequency estimation (half time)
Time frame: 6 months
Adherence to Mediterranean Diet (predimed) (half time)
Time frame: 6 months
Physical activity characterization
Time frame: 6 and 12 months
Emotional stress characterization
Time frame: 6 and 12 months
Emotional impact of the diagnosis characterization
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Habits and Parents, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joana Rossell (+34680264104, joanarossell@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food frequency estimation (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.