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
Conditions: Dietary Habits, Parents, Diabetes Mellitus, Type 1
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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Code: IIBSP-DDM-2023-166 
Version 4 Date: 27/06/2024 
STUDY PROTOCOL 
Dietary changes in adults in the family unit in newly diagnosed pediatric cases of type 
1 diabetes: impact of educational actions on routine practice 
 
Protocol version and date 
Version: 4.0 Date: 27/06/2024 
Protocol code 
IIBSP-DDM-2023-166 
Promotor 
 
Institut de Recerca Sant Pau (IR SANT PAU) 
C/ de Sant Quintí, 77,  
08041 Barcelona 
Tel: 93 556 56 17  
Coordinador Researcher 
Dídac Mauricio Puente, Chief of nutrition and 
endocrinology department 
Hospital de la Santa Creu i Sant Pau 
c/ Sant Antoni Maria Claret, 167 
08025 Barcelona 
Tel: 627953473 
e-mail: dmauricio@santpau.cat 
Principal investigator 
Joana Rossell Rusiñol, IR SANT PAU 
e-mail: jrossell@santpau.cat 
c/ Sant Sant Quintí 77-79 
08041 Barcelona 
Page number  
23 
This Study Protocol is the property of the Sant Pau Research Institute – IR Sant Pau, and is 
a confidential document. It should not be copied or distributed to other parties without 
prior written authorization from the Research Institute. 
 
 
 

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Code: IIBSP-DDM-2023-166 
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SUMMARY 
1. Resume 
 
 
 
 
 
 
 
 
 
1 
2. Abstract 
 
 
 
 
 
 
 
 
 
2 
3. Background  
 
 
 
 
 
 
 
 
3 
4. Hypothesis, primary and secondary objectives 
 
 
 
 
 
4 
4.1. Hypothesis 
 
 
 
 
 
 
 
 
4 
4.2. Primary objective 
 
 
 
 
 
 
 
4 
4.3. Secondary objective 
 
 
 
 
 
 
 
4 
5. Methods 
 
 
 
 
 
 
 
 
 
5 
5.1. Study Design 
 
 
 
 
 
 
 
 
5 
5.2. Study Period 
 
 
 
 
 
 
 
 
5 
5.2.1.  Recruitment Period  
 
 
 
 
 
 
5 
5.2.2.  Observational Study Period  
 
 
 
 
 
5 
5.3. Participant Follow-up 
 
 
 
 
 
 
 
5 
5.4. Study Population 
 
 
 
 
 
 
 
5 
5.5. Selection Criteria 
 
 
 
 
 
 
 
5 
5.5.1.  Inclusion criteria 
 
 
 
 
 
 
 
5 
5.5.2.  Exclusion criteria 
 
 
 
 
 
 
 
6 
5.5.3.  Withdrawal criteria  
 
 
 
 
 
 
6 
5.6. Study procedures 
 
 
 
 
 
 
 
6 
5.6.1.  Pre-screening 
 
 
 
 
 
 
 
6 
5.6.2.  Inclusion  
 
 
 
 
 
 
 
6 
5.7. Variables 
 
 
 
 
 
 
 
 
8 
5.7.1.  Main variables 
 
 
 
 
 
 
 
8 
5.7.2.  Other relevant variables 
 
 
 
 
 
 
9 
6. Data collection and analysis 
 
 
 
 
 
 
 
9 
6.1. Data Collection Schedule  
 
 
 
 
 
 
9 
6.2. Source of information 
 
 
 
 
 
 
 
9 
6.3. Data analysis 
 
 
 
 
 
 
 
 
9 
6.4. Sample size 
 
 
 
 
 
 
 
 
10 
6.5. Limitations of the design, data source, and analysis methods  
 
 
10 
 
7. Data management 
 
 
 
 
 
 
 
 
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7.1. Data collection and confidentiality  
 
 
 
 
 
11 
7.2. Mandatory requirements of the Data Protection Act, Regulation (EU) No. 2016/679, and Organic Law 
3/2018 on the Protection of Personal Data and Guarantee of Digital Rights (GDPR) 
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7.2.1.  Identification of the data and the subjects who process them 
 
 
11 
7.2.2.  Identification of the processing and legitimate basis for processing 
 
11 
7.2.3.  Tools used to process data  
 
 
 
 
 
12 
7.2.4.   International data transfers  
 
 
 
 
 
12 
7.2.5.  Identification of processing operations that may pose a high risk to the rights and freedoms of 
participants in the research project 
 
 
 
 
 
12 
7.2.6.  Rights of data subjects 
 
 
 
 
 
 
12 
7.2.7.  Data Validation and Quality Control  
 
 
 
 
12 
8. Work plan (tasks, milestones, and study timeline) 
 
 
 
 
13 
9. Ethical aspects 
 
 
 
 
 
 
 
 
13 
9.1. Benefit-Risk Assessment of the Research 
 
 
 
 
 
14 
9.2. Ethical Considerations, Regarding Subject Information and Informed Consent  
14 
9.3. Data Confidentiality 
 
 
 
 
 
 
 
14 
9.4. Interference with the Physician's Prescribing Habits  
 
 
 
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10. Plans for result dissemination  
 
 
 
 
 
 
15 
11. Study resources 
 
 
 
 
 
 
 
 
15 
12. Protocol modifications 
 
 
 
 
 
 
 
16 
13. Bibliography  
 
 
 
 
 
 
 
 
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14. Supplementary material (FFQ English version) 
 
 
 
 
 
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List of abbreviations 
aMED - Mediterranean Diet Adherence Index  
aHEI - Healthy Eating Index  
BEDCA - Spanish Food Composition Database 
EDC - Electronic data collection 
FFQ - Semi-quantitative food frequency questionnaire 
HADS - Hospital Anxiety and Depression Scale 
HSCSP - Hospital de la Santa Creu i de Sant Pau 
HUAV - Hospital Universitari Arnau de Vilanova 
IPAQ - International Physical Activity Questionnaire  
IR SANT PAU – Institut de Recerca Sant Pau 
MEDAS - Mediterranean Diet Adherence Screener  
MET - Metabolic equivalent task 
PIP - Pediatric Inventory for Parents 
T1D - Type 1 diabetes mellitus 
 
 
 

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1. RESUME 
Promoter identification 
Institut de Recerca Sant Pau (IR SANT PAU) 
C/ de Sant Quintí, 77, 
08041 Barcelona 
Tel : 93 556 56 17 
Study title 
Dietary changes in adults in the family unit in newly diagnosed 
pediatric cases of type 1 diabetes: impact of educational actions on 
routine practice 
Code 
IIBSP-DDM-2023-166 
Protocol version and date 
Version: 2.0 Approval date: 19/02/2024 
Coordinator investigator  
Dídac Mauricio Puente, Endocrinology and Nutrition service 
Hospital de la Santa Creu i Sant Pau 
c/ Sant Antoni Maria Claret, 167 
08025 Barcelona 
Tel: 935565661 
e-mail: dmauricio@santpau.cat  
Principal investigator 
Joana Rossell Rusiñol, IR SANT PAU 
e-mail: jrossell@santpau.cat  
Collaborator researchers 
 
Marta Hernández 
Mireia Tirado 
Laura Franquesa 
Marina I. Rojo 
Minerva Granado 
Jordi Bosch 
Priscila Llena 
Imma Sans 
Bogdan Vlacho 
Idoida Genua 
Berta Fernández 
Roque Cardona 
Serafin Murillo 
Marina Llobet 
Centros participantes 
Hospital de la Santa Creu i Sant Pau, Barcelona 
Hospital Universitari Arnau de Vilanova, Lleida  
Hospital Sant Joan de Déu, Esplugues de Llobregat 
Reference ethics comitee 
CEI Sant Pau 
Principal Aim 
To characterize dietary patterns in the family (parents or 
guardians) of people newly diagnosed with type 1 diabetes mellitus 
at the time of diagnosis, and to evaluate their evolution and the 
effect on health indicators after one year of evolution. 
Design 
Observational study on a prospective cohort  

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Disease of study 
Type 1 Diabetes mellitus 
Methods 
Recruitment of 26 family units of newly diagnosed patients with 
T1D (pre-screened upon hospital admission). 
Inclusion visit (within the first week of diagnosis). 
Follow-up visits at 6 months. 
Final visit at 12 months. 
Study 
population 
and 
total 
number of subjects 
26 family units (parents or guardians) of newly diagnosed T1D 
patients. 
Timeline. 
Study 
expected 
duration.  
The expected duration will be 3 years, including a 2-year 
recruitment period, and a one-year study period: 
- Recruitment start: April 2024. 
- Recruitment end: April 2026. 
- Study end: April 2027. 
Key words  
T1D, feeding patterns, family setting, diet, pediatric 
 
 
2. ABSTRACT 
Type 1 diabetes (T1D) is a chronic disease that often manifests at a young age and requires 
exogenous insulin administration to ensure adequate glycemic control, in addition to dietary 
education focused on carbohydrate intake control and healthy eating habits. Diabetic education 
is carried out in the close family (parents or guardians), whose involvement is necessary to 
ensure optimal glycemic control and the successful adaptation to a healthy dietary pattern in 
children and young adolescents. In this sense, parents (or guardians) of children and young 
adolescents with T1D receive diabetic education too to guarantee the successful adaptation to a 
healthy dietary pattern. Nevertheless, the modifications in dietary habits within the family unit 
remain relatively unexplored.  
We hypothesize that implementing healthier dietary patterns in the management of newly 
diagnosed T1D in children and young adolescents has a significant impact on the eating habits of 
the entire family environment. Therefore, in this study, we aimed at characterizing the dietary 
patterns of parents or guardians of individuals with newly diagnosed T1D at the time of diabetes 
diagnosis and at follow-up to assess the impact of routine diet and nutrition education within 
the family unit, regardless of the changes occurring in the index case itself.  
We expect to identify significant changes in the eating habits of the entire family in the first year 
after the diagnosis of T1D of a family member. These changes, derived from the diabetic 
education received, offer a potential intervention opportunity for a dietary improvement for the 
whole family.  
 
Keywords: Type 1 diabetes, alimentary patterns, family, diet 
 

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3. BACKGROUND 
Type 1 diabetes mellitus (T1D) is a chronic disease characterized by the autoimmune destruction of pancreatic 
beta cells, resulting in severely impaired insulin production. Unlike type 2 diabetes, in which insulin resistance 
plays a predominant role, T1D frequently presents at an early age, requiring exogenous insulin administration 
to achieve adequate glycemic control (1,2). In addition to insulin administration, choosing an appropriate diet, 
including carbohydrate counting and establishing good eating habits, is an important pillar in the management 
of T1D. The goal of dietary change is to ensure the child's proper development, help maintain blood glucose 
levels within optimal ranges, prevent the development of acute and chronic complications, and improve the 
quality of life with T1D (1–3). General recommendations for patients with diabetes are similar to those for the 
general population, based on a balanced diet with a caloric distribution within the range of 50-55% slow-
absorbing carbohydrates, 30-35% fats, and 10-15% proteins, limiting the consumption of snacks between 
meals (2,3). However, the relationship between dietary habits and T1D is inherently complex and multifaceted. 
Different dietary patterns can influence food absorption and insulin utilization, as well as the postprandial 
glycemic response (4). Advances in research have led to a better understanding of how food selection and 
macronutrient distribution are essential for their relationship with glycemic control and insulin requirements 
in people with T1D (4). In a systematic review we recently published to analyze the effectiveness of medical-
nutritional therapy in adolescents with T1D, we observed that dietary interventions delivered to children and 
adolescents and their families using carbohydrate counting, the use of multimedia applications, and diets rich 
in vegetables and/or vegetarians have a positive impact on glycemic control and lipid profile of adolescents 
with T1D (5). However, studies analyzing the effectiveness of medical-nutritional therapy in adolescents with 
T1D are scarce and of low reliability due to a large number of biases and limitations. On the other hand, we 
have explored the dietary patterns of adults with T1D in our population, observing that they exhibit healthier 
eating habits and greater adherence to the Mediterranean Diet than people without diabetes (6). 
Due to the individualized nature of diabetes management and the interindividual variability in glycemic 
response, there is no single dietary strategy that suits all individuals with T1D (3, 7, 8). In fact, implementing 
new eating habits requires a high degree of self-care on the part of the patient (9). In people with T1D, since 
they are usually diagnosed in childhood, an additional effort is required by the family unit, which ideally also 
receives the impact of behavioral interventions to make the necessary dietary changes (10). Thus, with a new 
diagnosis of a chronic disease such as T1D, not only the individual is exposed to a lifestyle change, but also 
their family environment. In this regard, it has been documented that parents are willing to make an effort to 
dedicate more time, as well as increase family financial spending, and adopt organizational changes aimed at 
maintaining a carbohydrate-controlled diet to maintain adequate blood glucose levels (11). However, these 
types of changes pose sources of emotional stress, especially related to the patient's glycemic control (12, 13). 
Additionally, the stress experienced by parents of a child with T1D can negatively impact the patient's glycemic 
control (13). In very young patients (under 6 years of age), behavioral problems related to eating have been 
described, which increase the stress perceived by families and are associated with lower adherence to dietary 
recommendations and worse glycemic control (12). 
Diet in a family is shaped by multiple internal and external factors. Therefore, a child's food choices are 
strongly influenced by those of parents and siblings (14). Thus, parents' dietary patterns shape the home food 
environment, influence the way the child thinks about food, and consequently influence the children's eating 
behavior (15, 16). Even the presence of other siblings influences dietary habits, as it has been reported that 
only children tend to have less healthy dietary patterns compared to families with a larger number of children 
(17). A recent diagnosis of T1D is one of the external factors that influence the family unit's dietary habits. 
However, there are very few scientific studies that evaluate the dietary patterns of families with children or 
adolescents with T1D. Most families with a child with T1D report that the affected child eats the same foods as 
non-diabetic family members (14). Furthermore, some dietary modifications have been reported based on the 
dietary guidelines at the time of diagnosis, such as relatives of children with T1D changing their choice of fats 

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and milk (18). A randomized controlled trial of a behavioral nutrition intervention conducted in families of 
young people with T1D showed that the dietary pattern measured in terms of diet quality was similar to that 
observed in the general population (19). However, these studies never evaluate the impact beyond the change 
in the patient themselves, and not in the family members. To the best of our knowledge, there are no scientific 
studies evaluating the impact of medical-nutritional therapy on the eating habits and lifestyle of other family 
members of children and adolescents newly diagnosed with T1D. 
 
4. HYPOTHESIS, PRIMARY AND SECONDARY OBJECTIVE 
4.1 Hypothesis 
Given the importance of the family environment in the evolution and management of T1D in children, and that 
the environment and the patient exert a bidirectional influence, there are no studies focused on studying the 
impact of diagnosis and management measures on potential changes in the diet and food choices of family 
members of children/adolescents with T1D. Studies focusing on dietary changes in patients provide insights 
into dietary recommendations for individuals with T1D, highlighting the importance of individualization and 
nutritional education in disease management. In this context, we firmly believe that adequately characterizing 
dietary patterns in adults in families with children with T1D is a very important aspect that has never been 
previously addressed. 
Our initial hypothesis is that the implementation of medical-nutritional therapy in terms of healthy eating for 
newly diagnosed individuals with T1D has a significant impact on the eating habits and lifestyle of the family 
members living with the patient. 
Furthermore, scientific studies focus solely on analyzing the impact of diabetes education on individuals with 
T1D themselves, without considering the changes that may occur within the family unit. To our knowledge, no 
studies have analyzed dietary and lifestyle changes among family members of patients living in the same 
household as a child/adolescent with newly diagnosed T1D, either in Spain or in other countries. In this regard, 
there is a lack of studies describing changes in the family unit's diet within routine clinical practice. 
4.2 Primary objective: 
 
To evaluate changes in dietary patterns and lifestyle among adults living in the family unit of a newly 
diagnosed patient with T1D one year after the diabetes diagnosis. 
4.3 Secondary objectives: 
*Due to the timeliness of the study, we also proposed: 
 
To characterize changes in the dietary patterns of parents or guardians of patients with T1D during 
follow-up (6 months after diagnosis). 
 
To determine, using a questionnaire, changes in the physical activity of the adult subjects in the study 
at 6 and 12 months. 
 
To determine, using a questionnaire, the emotional stress produced by the diagnosis and treatment 
of T1D in the adult parents or guardians belonging to the families of the incident case at 6 and 12 
months. 
 
To determine, using a questionnaire, the level of anxiety and depression produced by the diagnosis 
and treatment of T1D in the adults in the families at 6 and 12 months. 
 

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5. METHODS 
5.1 Study Design 
This study will be a prospective, multicenter, observational study. The study will be conducted within the 
Pediatrics Department of the Hospital de la Santa Creu i de Sant Pau (HSCSP) (Barcelona) and the Hospital 
Universitari Arnau de Vilanova (HUAV) (Lleida). This study will be launched at the participating centers once a 
favorable opinion has been obtained from the Research Ethics Committee, and in accordance with the 
legislative requirements for this type of observational study. 
The study design includes an initial visit that will coincide with the patient's inclusion in the study. Prior to the 
inclusion visit, a pre-screening period is planned. During this period, the potential candidate and their family 
will be invited, all study procedures will be explained and clarified, the selection criteria will be verified, and 
the inclusion visit will be scheduled. A follow-up visit will be conducted at 6 months throughout the study. A 
final visit will be conducted 12 months after enrollment (with a 1-month window). 
Adult subjects from 26 households of patients recently diagnosed with T1D are planned to be included. 
5.2 Study Period 
The study period is three years, from April 2024 to April 2027. 
5.2.1 Recruitment Period 
Participants will be recruited for two years, from April 2024 to April 2026. 
5.2.2 Observational Study Period 
Participation is for one year from enrollment. 
5.3 Participant Follow-up 
Given this is an observational study, no interventions will be performed on the study participants. Only three 
visits are required—baseline, 6-month follow-up, and 12-month follow-up—to collect variables and complete 
the questionnaires. These visits will be conducted as closely as possible to the routine hospital check-ups of 
the patient with T1D. 
5.4 Study Population 
The study population is the immediate family (parents or guardians) who regularly live with the person newly 
diagnosed with T1D. The questionnaire will be prioritized for the family member responsible for most of the 
food in the home. In the case of minors living in two separate family units, the unit in which they spend more 
than 60% of their time will be included, or both if the estimated time spent living together is equal. 
5.5 Selection Criteria 
5.5.1 Inclusion Criteria: 
 
Adults. 
 
Subjects of both sexes. 
 
Relatives of the pediatric population with newly diagnosed T1D according to ADA criteria. 
 
Within a maximum of one week of diagnosis of the disease in the index case with T1D in the family. 
 
Living with the family member with T1D for more than 40% of their time. 

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 
Being responsible for providing food for the household. 
5.5.2 Exclusion Criteria: 
 
Relatives of patients diagnosed with other types of diabetes (type 2, MODY, gestational, or other 
causes). 
 
Participant's family environment with a chronic illness or physiological conditions (e.g., pregnancy) 
that may influence eating habits. 
 
Significant dietary changes (switching to vegan, ketogenic, macrobiotic, intermittent fasting diets, 
etc.) recent to the onset of T1D (within the last month or at the time of inclusion). 
5.5.3 Withdrawal criteria: 
All participants have the right to withdraw from the study at any time, withdrawing their consent, without 
having to justify this decision and without any detriment to their clinical follow-up. Participants may also 
revoke the use of their data in the analysis, without justifying their decision, and without incurring any liability 
or harm. 
5.6 Study procedures 
This study will be launched at the participating centers once a favorable opinion has been obtained from the 
Research Ethics Committee and in accordance with the legislative requirements for this type of observational 
studies. 
5.6.1 Pre-screening 
Each study subject will be identified by the local investigator at each center during the admission of the newly 
diagnosed patient. Family members (parents or guardians) of all newly diagnosed subjects with a clinical 
diagnosis of T1D will be invited to participate. Study procedures will be performed by the local investigators at 
each participating center, who in some cases will be the same pediatric physicians and nurses as the 
participants' family members with T1D. A dedicated visit will be scheduled with the local investigator at each 
center to perform all study procedures in a single visit. 
5.6.2 Inclusion 
Each participant invited to participate will be informed about the study both verbally and in writing, using 
language adapted to their understanding. Participants will be provided with a document called the "Patient 
Information Sheet" containing all the information of the study, adapted to a simple comprehensive level. No 
participant will be included until they have been duly informed by the researcher and have freely given their 
informed consent to participate in the study. Once compliance with all selection criteria has been confirmed 
and informed consent has been given, data collection will begin by completing an electronic data collection 
form (EDC), which will record the information available in the patient's medical history or obtained during the 
inclusion visit. 
The inclusion visit will take place within the first week after a family member's T1D diagnosis. This will prevent 
any lifestyle and dietary changes from being made to the family environment. 
The initial clinical evaluation of all included subjects will be performed during the study inclusion visit. Clinical 
and sociodemographic variables related to the participant (will be collected using an ad-hoc questionnaire and 
a physical examination. The variables to be collected are defined in Table 1. Diet and intake patterns will be 
collected using questionnaires related to lifestyle and dietary patterns. 

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These variables will be collected at the inclusion visit, the 6-month follow-up, and at the end of the study at 12 
months. 
Table 1. Study variables 
Variable 
Source 
Value 
Sociodemographic variables 
Date of birth 
Questionnaire 
dd/mm/yyyy 
Age 
Questionnaire 
Years 
Sex 
Questionnaire 
Male / Female / Other / N/A 
Gender identity 
Questionnaire 
Male / Female / Other / N/A 
Area 
Questionnaire 
— 
Parents' education level 
Questionnaire 
No education / Secondary / Vocational 
training / University 
Family variables 
Number of people in the household 
Questionnaire 
Number 
Number of children and age 
Questionnaire 
Number 
Age of child with T1D 
Questionnaire 
Number 
Person responsible for feeding 
Questionnaire 
Mother / Father / Guardian 
Number of meals per day 
Questionnaire 
Number 
Number of meals at home per day 
Questionnaire 
Number 
Type of diet 
Questionnaire 
Omnivorous / Vegetarian / Vegan / Ovo-
lacto vegetarian / Other 
Toxic habits (all) 
Tobacco use 
Questionnaire 
(Smoker, non-smoker, ex-smoker), 
cigarettes/day 
Alcohol use 
Questionnaire 
(User, at-risk user, non-user), SDUs/day 
Drug use 
Questionnaire 
Other, (User, non-user) 
Other autoimmune diseases 
 
 
Celiac disease 
Questionnaire 
Yes / No 
Intolerances / allergies 
Questionnaire 
Yes / No. Which 
Autoimmune hypothyroidism 
Questionnaire 
Yes / No 
Others 
Questionnaire 
Yes / No. Which 
Other comorbidities 
Arterial hypertension 
Questionnaire 
Yes / No 
Dyslipidemia 
Questionnaire 
Yes / No 
Diabetes 
Questionnaire 
No / T1D / T2D / LADA / Other 
Diabetes duration 
Questionnaire 
Years 
Cardiovascular disease 
Questionnaire 
Yes / No 
Liver disease (excluding steatosis) 
Questionnaire 
Yes / No 
Liver steatosis 
Questionnaire 
Yes / No 
Renal insufficiency 
Questionnaire 
Yes / No 
Clinical variables 
BMI (Body Mass Index) 
Visit 
(kg/m²) 
Waist circumference 
Visit 
(cm) 
Diastolic blood pressure 
Visit 
(mm Hg) 
Systolic blood pressure 
Visit 
(mm Hg) 
Weight 
Visit 
(kg) 
Height 
Visit 
(cm) 
Associated treatments 
Antidiabetic drugs 
Questionnaire 
Yes/No/if yes dosage 
Lipid-lowering agents 
Questionnaire 
Yes/No/if yes dosage 
Antiplatelet agents 
Questionnaire 
Yes/No/if yes dosage 
Anticoagulants 
Questionnaire 
Yes/No/if yes dosage 
Antihypertensives 
Questionnaire 
Yes/No/if yes dosage 

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5.7 Variables 
This study aims to include as many dietary characteristics at baseline and follow-up as realistically possible. 
The variables considered essential are described below. 
5.7.1 Main Variables 
Eating patterns and dietary information collected using the following questionnaires: 
 
Semi-quantitative food frequency questionnaire (FFQ) validated in the Spanish population (20). This 
questionnaire consists of 137 items. They collect the average food intake over the past year. Food 
consumption frequencies are recorded in nine levels (never or mostly never, 1-3 times/month, 1 
time/week, 2-4 times/week, 5-6 times/week, 1 time/day, 2-3 times/day, 4-6 times/day, and more 
than 6 times/day). Food consumption frequencies will be calculated as the number of meals per day 
and multiplied by the weight of the portion sizes indicated in the questionnaire. Nutrient intake will 
be adjusted for energy intake. In addition, participants who have not made any changes to their 
dietary habits during the past year prior to the study will be asked at the first visit. Nutritional data 
will be extracted using the Spanish Food Composition Database (BEDCA), developed by the RedBEDCA 
and the Spanish Agency for Food Safety and Nutrition (21). 
(An English version is attached at the end of this protocol). 
 
Mediterranean Diet Adherence Index (aMED) to assess the degree of adherence to the 
Mediterranean Diet. Based on the Mediterranean Diet Scale (22), which includes the intake of 
vegetables, legumes, fruits, nuts, grains, red and processed meats, fish, the ratio of 
monounsaturated/saturated fats, and alcohol; the scoring scale ranges from 0 to 9 points. 
 
Healthy Eating Index (aHEI), based on the American Dietary Guidelines and the Healthy Eating 
Pyramid (23), which contains 9 items related to healthy food intake, with a maximum score of 87.5. 
 
Mediterranean Diet Adherence Screener (MEDAS): The MEDAS (Mediterranean Diet Adherence 
Screener) is a tool used to assess the degree of adherence to the Mediterranean Diet. It consists of 14 
questions that explore different aspects of the characteristic dietary pattern of this diet (24). Each 
question is assigned a value depending on the frequency or quantity of consumption reported. The 
total score of the MEDAS questionnaire can range from 0 to 14 points, where a higher score indicates 
greater adherence to the Mediterranean Diet. This questionnaire provides an overview of an 
individual's dietary pattern and its alignment with the principles of the Mediterranean diet. 
Physical Activity Log: 
 
International Physical Activity Questionnaire (IPAQ) validated in Spanish (25). Physical activity will be 
classified as low, medium, and high, based on the estimated energy expenditure for each activity. 
Activities with a metabolic equivalent task (MET) of 8 METs will be classified as vigorous; moderate 
activities with an energy expenditure of 4 METs; and light activities with 3.3 METs, such as walking, 
will be classified as sedentary or active if study participants engage in moderate physical activity for at 
least 30 minutes per day. 
Parental Stress: 
 
Pediatric Inventory for Parents (PIP) (26): This is a questionnaire comprising 42 items, grouped into 
four domains or subscales. The purpose of the questionnaire is to measure the stress levels 
experienced by parents or caregivers of children with chronic illnesses. This questionnaire is scored on 
a Likert scale ranging from 1 (never/not at all) to 5 (always/extremely). Higher scores indicate higher 
stress levels. 

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 
The Hospital Anxiety and Depression Scale (HADS) (27) is a questionnaire that detects emotional 
stress in non-psychiatric patients in a hospital setting. The questionnaire has been previously used in 
several studies to measure the emotional stress levels of parents or caregivers of children with type 1 
diabetes. This questionnaire consists of 14 items grouped into two subscales, one for anxiety and one 
for depression. Responses are scored on a Likert scale ranging from 0 to 4 points. 
5.7.2 Other relevant variables 
To conduct the study and properly assess the main variables, relevant sociodemographic and clinical variables 
will be collected to complement the information obtained through the questionnaires (Table 1). These 
secondary variables provide us with complementary information on their lifestyle, general health status, type 
of family unit, and the possible effects of changing. 
 
6. DATA COLLECTION AND ANALYSIS 
6.1 Data Collection Schedule 
The study period is estimated to be 3 years (from April 2024 to February 2027). However, these times may be 
modified due to the administrative process for launching the study. 
6.2 Source of Information 
In all cases, the source of information will be that obtained through the diet and physical activity 
questionnaires and through the physical examination of parents/guardians during the visits according to the 
schedule on Table 2. All information will be recorded in the EDC.  
Table 2. Data collection schedule during the study 
 
Inclusion Basal (t= 0) 
Follow-up 
(6 months) 
Final 
(12 months) 
Informed consent 
X 
 
 
 
Physical exploration 
 
X 
X 
X 
FFQ 
 
X 
X 
X 
MEDAS 
 
X 
X 
X 
IPAQ 
 
X 
X 
X 
PIP 
 
X 
X 
X 
HADS 
 
X 
X 
X 
FFQ, Semi-quantitative food frequency questionnaire; MEDAS, Mediterranean Diet Adherence Screener; IPAQ, 
International Physical Activity Questionnaire; PIP, Pediatric Inventory for Parents; HADS, Hospital Anxiety and Depression 
Scale. 
6.3 Data Analysis 

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Data validation and quality control will first be performed through a descriptive analysis, expressing 
frequencies and extreme values for all recorded variables. Any errors detected will be corrected through a 
search for and recovery of missing data and an analysis of inconsistencies. Subsequently, a description of the 
sample will be provided, expressing the frequency distribution of the qualitative variables, and the arithmetic 
mean, median, and standard deviation, as well as maximum and minimum values for the quantitative 
variables. 
The main analysis will consist of estimating the frequency and/or mean of post-treatment changes 
(reduction/increase). A paired data analysis of the changes will also be performed. A mixed-effects analysis 
(linear link GLM) will be performed for continuous variables. This same analysis will be performed for other 
dichotomous efficacy variables (improvement or lack thereof in each parameter) using logistic link GLM 
models. In addition, for the comparative analysis from time 0 to 6 months, parametric and nonparametric 
comparison tests (Student's t-test, chi-square, Wilcoxon test) and linear regressions will be applied to observe 
the influence between variables, taking into account the follow-up time. Family units will be phenotyped based 
on their variables by creating clusters using the k-means algorithm. 
In all analyses, a type I error or α of 5% will be established, with statistical significance when p values are less 
than 0.05, and a type β error of 20% (statistical power of 80%). Statistical analyses will be performed using the 
R Core Team statistical package (2023) v. 4.3. 
6.4 Sample Size 
The sample size was calculated based on the results of a previous study published by our group on the dietary 
pattern of adult patients with T1D compared to subjects without diabetes in Spain (6). This is the most 
informative method available, and we assume that the adults in our study will have a similar pattern. We 
considered the mean and standard deviation of a group of adult individuals with T1D for adherence to the 
Mediterranean Diet, calculated with aMED. With a statistical power of 80% and an alpha error of 5%, it was 
calculated that a total of 26 newly diagnosed patients (one family unit) would be necessary to detect a 
minimum difference of 1 point on the aMED, performing the mean comparison test for two paired samples 
(pre-post analysis). As a contingency, recruiting 16 family units would also guarantee a statistical power of 80% 
and an alpha error of 5% to detect a minimum difference of 5 points in the aHEI index. The latter is also based 
on our own study in the T1D population. The family unit can be composed of both or just one parent, as long 
as they are responsible for most of the family meals. In the case of patients with shared custody, if the patient 
spends 40% or more of their time with one family, that family will be counted as a family unit. 
6.5 Limitations of the design, data source, and analysis methods 
Several potential limitations have been identified in the study. 
 
Selection of a small number of participants. We prioritized a realistic approach for an initial project 
that is feasible but also sufficiently representative. 
 
Wide pediatric age range. The influence of the environment outside the family will have some impact 
on the older population. 
 
Family diversity. Our goal is to collect data on the real impact and avoid biases based on different 
family realities. Thus, it is anticipated that data will be collected from patients who live with one or 
more families. 
 
 
 

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7. DATA MANAGEMENT 
7.1 Data Collection and Confidentiality 
Data will be entered by the researchers themselves and/or authorized personnel directly into the EDC. To 
ensure the confidentiality of the data obtained from the study, only the local researcher and their team of 
collaborators, the sponsor or their designated person, the REC, the relevant health authorities, and those 
responsible for data analysis will have access to them. 
Regarding the EDC, each researcher will be provided with a username and a password consisting of between 4 
and 6 digits in a sealed document. These codes are considered confidential and non-transferable and are 
subject to the same confidentiality rules as all other documents, including the protocol. Researchers are 
responsible for keeping their passwords confidential and not disclosing them to third parties. To gain access to 
the EDC, researchers must sign the study investigator commitment and confidentiality agreement. 
The content of the EDC, as well as the documents generated during the study and the database, will be 
protected from unauthorized use by persons outside the research project and, therefore, will be considered 
strictly confidential and will not be disclosed to third parties. Furthermore, the EDC will be automatically 
disconnected if there is no activity for more than 10 minutes. This will protect the EDC from unauthorized 
access, should the study investigator leave the EDC open for any reason. 
Patients included at each center will have a consecutive number (code), automatically generated by the EDC 
once the informed consent form has been signed and the EDC inclusion criteria have been met. This patient 
code will be documented in the participant's medical record and in the confidential patient inclusion record in 
the investigator's folder at each participating center. 
7.2 Mandatory requirements of the Data Protection Act, Regulation (EU) No. 2016/679, and 
Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital Rights (GDPR) 
7.2.1 Identification of the data and the subjects who process them 
The variables required to carry out the study are those specified in the variable section (Table 1) and will be 
collected from the participants after obtaining informed consent and collecting data through the EDC during 
follow-up visits. The information will be coded. Coding will be done through the EDC as specified in section 7.1 
Data collection and confidentiality. 
7.2.2 Identification of the processing and legitimate basis for processing 
The processing of the personal data required in this study is governed by Organic Law 3/2018, of December 5, 
on the protection of personal data. The principal investigator of the study and the sponsor, the Institut de 
Recerca Sant Pau (IR SANT PAU), C/ de Sant Quintí, 77, 08041 Barcelona, Tel: +34 93 556 56 17, act as data 
controllers within the framework of this study. The data ultimately recorded in the central database will 
remain the property of the sponsor. The identity of the participants will not be revealed to any other person 
except to the health authorities, when required or in cases of medical emergency. The Research Ethics 
Committees, representatives of the Health Authority for inspection purposes, and personnel authorized by the 
sponsor will only have access to the data to verify personal data, clinical study procedures, and compliance 
with good clinical practice standards (always maintaining the confidentiality of the information). 
The researcher and the sponsor are required to retain the data collected for the study for at least 5 years after 
its completion. Subsequently, personal information will only be retained by the patient's healthcare center and 
the sponsor for other scientific research purposes if the patient has given their consent to do so, and if 
permitted by applicable law and ethical requirements. 

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Legal basis for processing: GDPR: 6.1 a) the data subject has given their consent to the processing of their 
personal data for one or more specific purposes. 
7.2.3 Tools used to process data 
The REDCAP platform will be used to carry out the project. It is hosted on the servers of the sponsor, the IR 
Sant Pau, and is implemented with the security measures established by the institution. The data is stored on 
the local web server where the organization has installed the software and is therefore only accessible on 
computers with a trusted connection via VPN and secure credentials (certificates, RSA keys, or complex 
passwords). 
7.2.4 International data transfers 
There will be no international data transfers. 
7.2.5 Identification of processing operations that may pose a high risk to the rights and freedoms of 
participants in the research project 
In accordance with Article 35 of the GDPR, the project does not meet the requirements that require the 
corresponding impact assessment. 
7.2.6 Rights of data subjects 
In accordance with Regulation (EU) No. 2016/679 and Organic Law 3/2018 on the Protection of Personal Data 
and the Guarantee of Digital Rights, patients may limit the processing of inaccurate data, request a copy, or 
request the transfer of the data they have provided for the study to a third party (portability). To exercise 
these rights, you must contact the principal investigator, the researchers at the study site, or the center's Data 
Protection Officer, where applicable, at the center or sponsor: IR SANT PAU, C/ de Sant Quintí, 77, 08041 
Barcelona, Tel: +34 93 556 56 17, email: dpo_ir@santpau.cat, or the Spanish Data Protection Agency at Jorge 
Juan, 
6, 
28001 
Madrid 
(https://www.aepd.es/es) 
or 
the 
Catalan 
Data 
Protection 
Authority 
(https://apdcat.gencat.cat). 
If the participant wants to know more about it, he/she can contact the Data Protection Officer of the 
institution or the promoter IR SANT PAU, C/ de Sant Quintí, 77, 08041 Barcelona, Tel: 93 556 56 17, email: 
dpd@santpau.cat, or with the Spanish Data Protection Agency at Jorge Juan, 6, 28001 Madrid 
(https://www.aepd.es/es) or the Catalan Data Protection Authority (https://apdcat.gencat.cat). 
7.2.7 Data Validation and Quality Control 
All data received through the use of the EDC will be stored and subject to the appropriate working procedures 
to comply with FDA standard 21 CFRe Part 11, thereby guaranteeing their confidentiality, security, and 
authenticity. The adaptation of the 21 CFRe Part 11 standard ensures that data received via electronic 
transmission is as valid as original data received on paper. This standard establishes the rules for the use of 
electronic data and defines the requirements for all systems for their collection, storage, maintenance, and 
security. 
All data entered by the researcher in the system will be reviewed by an automatic validation program, and 
discrepancy reports will be generated accordingly to facilitate correct and complete data entry (automatic 
queries). Furthermore, the entered data will be reviewed and verified by the study monitor. Corrections to the 
EDC will be made by the researchers themselves. The original data must be available and ready for review 
during scheduled monitoring visits. 

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Furthermore, all documents related to this study must be made available to the appropriately qualified 
personnel responsible for conducting any audits or inspections that may be carried out. Verification of the ECR 
data must be performed by direct inspection of the original documents. 
 
8. WORK PLAN (tasks, milestones, and study timeline) 
This project is divided into phases: 
Phase 1 (April 2024 - April 2026): Recruitment. 
Recruitment will begin in February, the expected date for obtaining the IRB documentation from each center. 
This period will last two years. 
Phase 2 (April 2024 - April 2026): First visit. 
Once the participants have been recruited and have signed the IRB, their first visit will include completing the 
questionnaires, interview, and physical examination. This first visit will take place no more than one week after 
the child's T1D diagnosis. 
Phase 3 (September 2024 - September 2026): Follow-up. 
The follow-up visit will take place 6 months after the first visit. The questionnaires, interview, and physical 
examination will be repeated. 
Phase 4 (April 2025 - April 2027): Final visit. 
The final visit will be conducted 12 months after the first visit. The questionnaires, interview, and physical 
examination will be repeated. 
Phase 5 (September 2026 - April 2027): Data analysis. 
In the final part of the study, the data of the patients who completed the final visit will be analyzed. This will 
begin with database cleaning and management, analysis, and subsequent interpretation and discussion of the 
results. 
Phase 6 (April 2027): Study closure. 
Once all final visits are completed, data analysis will be finalized, and communications and manuscripts will be 
prepared. A research meeting will be held to prepare the final report and close the study. 
 
9. ETHICAL ASPECTS: 
This study complies with all ethical aspects and the protection of participating subjects by complying with the 
ethical precepts formulated in Royal Decree 957/2020 and the Biomedical Research Law 14/2007, of July 3, 
and in the Declaration of Helsinki and all its revisions. 
Given that this study is observational in nature, patient participation is considered to entail minimal risk, i.e., 
the risk is similar to that which the patient would have in clinical practice without participation in the study. It 
is an unconditional prerequisite for a patient's participation to obtain their consent after having been informed 

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by the researcher about the information, both verbally and in writing, in a language that allows its content to 
be fully legible and understandable to the patient. 
The protocol will be submitted for evaluation by a Research Ethics Committee prior to the start of patient 
enrollment. Any data required by the protocol may be subject to audits by the sponsor, independent 
organizations, and/or competent authorities, but data confidentiality, in accordance with the aforementioned 
law, will always be an essential condition. 
Participating subjects may revoke their consent for the use of their data in the analysis at any time, without 
giving reasons and without incurring any liability or harm. 
Before accepting and signing the researcher's commitment, participating clinicians must ensure that their 
participation in the study does not interfere with their prescribing habits or their healthcare duties. 
9.1 Benefit-Risk Assessment of the Research 
This project addresses the priority of developing personalized medicine. This project adopts a research 
approach that is clearly aimed at improving clinical decision-making that affects the people we serve. The 
potential impact may be equivalent to that mentioned for diabetes itself. The patient will not be at risk in this 
study as it is entirely observational and therefore will not be subject to any intervention, whether dietary or 
pharmacological. This study is limited to recording anonymized data in a database that does not allow access 
to the patient's personal data. 
9.2 Ethical Considerations, Regarding Subject Information and Informed Consent 
The study will be conducted in strict accordance with international ethical recommendations for medical 
research involving humans. The researcher will be responsible for ensuring that the study is conducted in 
accordance with the standards set forth in the Declaration of Helsinki. 
Before starting the study, the Research Ethics Committee of the HSCSP must approve the study protocol, the 
information that will be provided to the subject, and the informed consent form that will be used. 
The Research Ethics Committee will be informed of any subsequent amendments to the protocol and should 
be requested if a further evaluation of the ethical aspects of the study is necessary. 
It is the researcher's responsibility to obtain the patient's informed consent. The patient may not participate in 
any specific study procedure without obtaining their consent or that of their legal guardian/family member if 
the patient is unable to give consent due to their clinical condition. 
Before including any subject in the study and before obtaining informed consent, the researcher or a person 
designated by the researcher will explain the objectives, methods, potential risks of the study, and any 
discomfort it may cause to the potential participant or their legal guardian/family member. The nature, scope, 
and potential consequences of the study will be explained in understandable language. Rights related to data 
protection law will be explained, as will the possibility of being contacted in the case of future studies related 
to diabetes. The potential participant or their legal guardian/family member must be given time to consider 
their decision to participate in the study and have the opportunity to ask questions. After this explanation, and 
before entering the study, consent must be properly recorded by the signature of the subject or their legal 
guardian/family member. The informed consent must be signed in three copies: one for the participant, one 
for the researcher, and the third copy for the biobank. 
9.3 Data Confidentiality 

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Regarding the confidentiality of study data, the provisions of Organic Law 3/2018, of December 5, on the 
Protection of Personal Data and Guarantee of Digital Rights, and the General Data Protection Regulation (EU) 
2016/679, will be followed. 
9.4 Interference with the Physician's Prescribing Habits 
The study will not interfere with the clinical management habits of patients. 
 
10. PLANS FOR RESULT DISSEMINATION 
It is anticipated that, starting in the second year of the project, the results generated will be presented at 
leading national and international conferences in diabetes research, such as the Spanish Diabetes Society 
Conference and the European Diabetes Society Conference. 
In addition, a scientific article for each study objective will be published in high-impact journals in the field. 
 
11. STUDY RESOURCES 
This project uses the resources and infrastructure of the two participating centers. 
At the HSCSP, the Pediatric Endocrinology Unit has three pediatric endocrinology specialists and a nurse 
specializing in nutrition who is responsible for the diabetes education of patients with T1D. The hospital serves 
five districts in the city of Barcelona, with a population of over 400,000. It is estimated that the number of new 
T1D diagnoses is 15 patients per year, to which will be added those diagnosed up to the age of 20. The 
estimated total is 24 patients. Patients are admitted through the emergency department or referred from 
other primary care centers and are admitted for one week, at which point the professionals begin nutritional 
education. The Endocrinology Department at Sant Pau Hospital has a research unit with statistical support 
available for data evaluation and management, as well as for processing results for analysis. 
The Pediatric Endocrinology Unit of the Pediatric Department at HUAV in Lleida has two pediatric specialists 
with extensive experience in diabetes treatment and a dedicated diabetes educator nurse with specific 
training in diabetes and nutrition education and years of experience caring for patients. The unit serves a 
population corresponding to the province of Lleida, as well as patients referred from the Franja de Aragón 
region. Approximately 15 patients are admitted each year for onset diabetes. Admission care is provided for 
children up to the age of 15, and newly diagnosed children up to the age of 20 will be added; for an estimated 
total of 25 patients at this center. Patients receive education upon diagnosis, both from doctors and from 
nursing professionals, as well as from the diabetes educator. Patients are usually admitted for a week. 
Subsequently, they are followed up in outpatient clinics by various team professionals. Basic supervision is also 
provided by the mental health team at the CSMIJ in Lleida. Initial training includes nutritional education, which 
recommends the ideal number of servings for each patient and their distribution throughout the day, in 
addition to comprehensive education on healthy dietary habits. It is conducted annually. 
Within the teaching function, a course is offered to teaching staff from schools and high schools in the area, in 
collaboration with the hospital's teaching classroom. 
The Sant Joan de Déu Hospital, a leading pediatric hospital in the Barcelona area, is also participating in the 
study. Its endocrinology unit receives 13,000 visits per year, with consultations for DM1 being one of the most 
frequent. They have a team of pediatric endocrinologists and nurses who provide educational interventions to 

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patients and their families during the stay following a DM1 diagnosis. The hospital has a web portal with 
information, advice, and other resources for patients with DM1 and their families. The number of new DM1 
diagnoses varies widely, but the expected recruitment rate is expected with the participation of both hospitals. 
These hospitals have affiliated research institutes, the Lleida Biomedical Research Institute, the IR Sant Pau, 
and the Sant Joan de Déu Research Institute, which have the infrastructure and personnel necessary to carry 
out the project. The principal investigator of the project belongs to the Sant Pau Research Institute. The crucial 
leadership of women in this research not only promotes diversity and equity in scientific research but also 
represents an essential contribution to elevating excellence in biomedical research, opening new paths and 
approaches in the field of health. J. Rossell is a dietitian-nutritionist, with a PhD in Biomedicine, with extensive 
experience in the field of basic and translational research focused on nutrition, endocrinology, and 
complications associated with diabetes. She is an affiliated researcher with the CIBERDEM research group at 
the Sant Pau Biomedical Research Institute and is part of the Endocrinology, Diabetes, and Nutrition research 
group, both led by Dr. Mauricio. This group has extensive experience in the study of diabetes and 
complications associated with dietary and lifestyle habits, which has resulted in a large number of national and 
international projects and, consequently, scientific publications in high-impact international journals. 
 
12. PROTOCOL MODIFICATIONS: 
Any modification to the study protocol will always take the form of a written amendment or addendum. 
Formalization requires the approval of all persons responsible for the study. For significant modifications, 
express approval from the Clinical Research Ethics Committee will be requested. 
 
 

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13. BIBLIOGRAPHY  
1. American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in 
Diabetes- 2021. Diabetes Care. 2021 Jan;44(Suppl 1):S15–33.  
2. Smart CE, Annan F, Higgins LA, Jelleryd E, Lopez M, Acerini CL. ISPAD Clinical Practice Consensus Guidelines 
2018: Nutritional management in children and adolescents with diabetes. Pediatr Diabetes. 2018 Oct;19 Suppl 
27:136–54. 3. Tascini G, Berioli MG, Cerquiglini L, Santi E, Mancini G, Rogari F, Toni G, Esposito S. Carbohydrate 
Counting in Children and Adolescents with Type 1 Diabetes. Nutrients. 2018 Jan 22;10(1):109.  
4. O’Keefe JH, Gheewala NM, O’Keefe JO. Dietary strategies for improving post-prandial glucose, lipids, 
inflammation, and cardiovascular health. J Am Coll Cardiol. 2008 Jan 22;51(3):249–55.  
5. Granado-Casas M, Solà I, Hernández M, Rojo-López MI, Julve J, Mauricio D. Effectiveness of medical 
nutrition therapy in adolescents with type 1 diabetes: a systematic review. Nutr Diabetes. 2022 Apr 
22;12(1):24.  
6. Granado-Casas M, Alcubierre N, Martín M, Real J, Ramírez-Morros AM, Cuadrado M, Alonso N, Falguera M, 
Hernández M, Aguilera E, Lecube A, Castelblanco E, Puig-Domingo M, Mauricio D. Improved adherence to 
Mediterranean Diet in adults with type 1 diabetes mellitus. Eur J Nutr. 2019 Sep;58(6):2271–9.  
7. Lennerz BS, Barton A, Bernstein RK, Dikeman RD, Diulus C, Hallberg S, Rhodes ET, Ebbeling CB, Westman EC, 
Yancy WS Jr, Ludwig DS. Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet. Pediatrics. 2018 
Jun;141(6):e20173349.  
8. Levran N, Levek N, Sher B, Gruber N, Afek A, Monsonego-Ornan E, Pinhas-Hamiel O. The Impact of a Low- 
Carbohydrate Diet on Micronutrient Intake and Status in Adolescents with Type 1 Diabetes. Nutrients. 2023 
Mar 15;15(6):1418.  
9. Albourhi A, Halim FA. Impacts on the Family due to Living with Child having Type 1 Diabetes Mellitus. Journal 
of Diabetes & Metabolism. 2021 Feb 22;12(2):1–6. 
10. Hilliard ME, Powell PW, Anderson BJ. Evidence-based behavioral interventions to promote diabetes 
management in children, adolescents, and families. Am Psychol. 2016 Oct;71(7):590–601.  
11. Harray AJ, Roberts AG, Crosby NE, Shoneye C, Bebbington K. Experiences and Attitudes of Parents Reducing 
Carbohydrate Intake in the Management of Their Child’s Type 1 Diabetes: A Qualitative Study. Nutrients. 2023 
Mar 29;15(7):1666.  
12. Pierce JS, Kozikowski C, Lee JM, Wysocki T. Type 1 diabetes in very young children: a model of parent and 
child influences on management and outcomes. Pediatr Diabetes. 2017 Feb;18(1):17–25.  
13. Bassi G, Mancinelli E, Di Riso D, Salcuni S. Parental Stress, Anxiety and Depression Symptoms Associated 
with Self- Efficacy in Paediatric Type 1 Diabetes: A Literature Review. Int J Environ Res Public Health. 2020 Dec 
28;18(1):152.  
14. Virtanen SM, Virta-Autio P, Räsänen L, Akerblom HK. Changes in food habits in families with a newly 
diagnosed child with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2001;14 Suppl 1:627–36.  
15. Mahmood L, Flores-Barrantes P, Moreno LA, Manios Y, Gonzalez-Gil EM. The Influence of Parental Dietary 
Behaviors and Practices on Children’s Eating Habits. Nutrients. 2021 Mar 30;13(4):1138.  
16. Mahmood L, Moreno LA, Flores-Barrantes P, Mavrogianni C, Schwarz P, Makrilakis K, Liatis S, Cardon G, 
Willems R, Rurik I, Radó S, Tankova T, Iotova V, Usheva N, Manios Y, Gonzalez-Gil EM. Parental food 
consumption and diet quality and its association with children’s food consumption in families at high risk of 
type 2 diabetes: the Feel4Diabetes-study. Public Health Nutr. 2022 Oct 11;25(12):1–12.  
17. Kracht CL, Sisson SB, Guseman EH, Hubbs-Tait L, Arnold SH, Graef J, Knehans A. Family Eating Behavior and 
Child Eating Patterns Differences Between Children With and Without Siblings. J Nutr Educ Behav. 
2019;51(10):1188–93.  
18. Virta-Autio P, Virtanen SM, Räsänen L, Aro A, Tuomilehto J, Åkerblom HK. Changes in Milk and Fat Choices 
of Nondiabetic Siblings of Newly Diagnosed DiabeticChildren: A Two-Year Prospective Study. Journal of 
Nutrition Education. 1996 Sep 1;28(5):272–8.  
19. Lipsky LM, Haynie DL, Liu A, Nansel TR. Resemblance of Diet Quality in Families of Youth with Type 1 
Diabetes Participating in a Randomized Controlled Behavioral Nutrition Intervention Trial in Boston, MA (2010-
2013): A Secondary Data Analysis. J Acad Nutr Diet. 2019 Jan;119(1):98–105.  
20. Fernández-Ballart JD, Piñol JL, Zazpe I, Corella D, Carrasco P, Toledo E, Perez-Bauer M, Martínez-González 
MA, Salas-Salvadó J, Martín-Moreno JM. Relative validity of a semi-quantitative food-frequency questionnaire 
in an elderly Mediterranean population of Spain. Br J Nutr. 2010 Jun;103(12):1808–16.  
21. BEDCA [Internet]. [cited 2023 Oct 30]. Available from: https://www.bedca.net/  

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22. Schröder H, Fitó M, Estruch R, Martínez-González MA, Corella D, Salas-Salvadó J, Martín-Moreno JM. A 
Short Screener Is Valid for Assessing Mediterranean Diet Adherence among Older Spanish Men and 
Women123. The Journal of Nutrition. 2011 Jun 1;141(6):1140–5.  
23. McCullough ML, Feskanich D, Stampfer MJ, Giovannucci EL, Rimm EB, Hu FB, Spiegelman D, Hunter DJ, 
Colditz GA, Willett WC. Diet quality and major chronic disease risk in men and women: moving toward 
improved dietary guidance. Am J Clin Nutr. 2002 Dec;76(6):1261–71  
24. Schröder H, Fitó M, Estruch R, Martínez-González MA, Corella D, Salas-Salvadó J, et al. A short screener is 
valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011 
Jun;141(6):1140–5. DOI: 10.1161/CIR.0000000000000659  
25. Román Viñas B, Ribas Barba L, Ngo J, Serra Majem L. [Validity of the international physical activity 
questionnaire in the Catalan population (Spain)]. Gac Sanit. 2013;27(3):254–7.  
26. Del Rincón C, Remor E y Arranz P. (2007). Estudio psicométrico preliminar de la versión española del 
Pediatric Inventory for Parents (PIP). International Journal of Clinical and Health Psychology, 7 (2), 435-452. 
27. Herrero, M.J., Blanch, J., Peri, J.M., De Pablo, J., Pintor, L., y Bulbena, A. (2003). A validation study of the 
Hospital Anxiety and Depression Scale (HADS) in a Spanish population. General Hospital Psychiatry, 25, 277-
283 
 
 
 

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14. Supplementary material 
Semi-quantitative food frequency questionnaire (Translated from the Spanish version) 
  
Never or 
almost 
never 
Month 
Times/week 
Times/day 
1-3 
times 
Once 
2-4 
5/6 
Once 
2/3 
4/6 
+6 
Section I: Fruits & Fruit Juices (Items 1–12) 
  
  
  
  
  
  
  
  
  
1. Orange (1), grapefruit (1) or tangerines (2) 
  
  
  
  
  
  
  
  
  
2. Banana (1) 
  
  
  
  
  
  
  
  
  
3. Apple or pear (1) 
  
  
  
  
  
  
  
  
  
4. Fresh orange juice (1 glass, 200 mL) 
  
  
  
  
  
  
  
  
  
5. Bottled or canned fruit juice (200 mL) 
  
  
  
  
  
  
  
  
  
6. Cherries, sour cherries, plums (dessert 
plate) 
  
  
  
  
  
  
  
  
  
7. Grapes (1 bunch or 20 berries) 
  
  
  
  
  
  
  
  
  
8. Strawberries, raspberries, blackberries 
(dessert plate) 
  
  
  
  
  
  
  
  
  
9. Dried fruit (apricots, figs, raisins) (30 g) 
  
  
  
  
  
  
  
  
  
10. Other fresh fruit (1 piece or 150 g) 
  
  
  
  
  
  
  
  
  
11. Citrus fruits other than orange or 
tangerine 
  
  
  
  
  
  
  
  
  
12. Fruit salads or compotes (1 bowl) 
  
  
  
  
  
  
  
  
  
Section II: Vegetables & Legumes (Items 13–28)  
13. Raw leafy greens or salad vegetables (1 
plate) 
  
  
  
  
  
  
  
  
  
14. Cooked leafy greens (spinach, chard) (1 
plate) 
  
  
  
  
  
  
  
  
  
15. Raw cruciferous vegetables (broccoli, 
cauliflower, cabbage) (1 plate) 
  
  
  
  
  
  
  
  
  
16. Cooked cruciferous vegetables (1 plate) 
  
  
  
  
  
  
  
  
  
17. Tomatoes (raw or cooked) (1 medium 
fruit or 1 plate) 
  
  
  
  
  
  
  
  
  
18. Bell peppers, cucumber, celery (1 plate) 
  
  
  
  
  
  
  
  
  
19. Onion, garlic, leeks (added in cooking) (1 
serving) 
  
  
  
  
  
  
  
  
  
20. Other cooked vegetables (eggplant, 
zucchini, carrots) (1 plate) 
  
  
  
  
  
  
  
  
  
21. Legumes (lentils, chickpeas, beans) 
(150 g) 
  
  
  
  
  
  
  
  
  
22. Peas (150 g) 
  
  
  
  
  
  
  
  
  
23. Broad beans (150 g) 
  
  
  
  
  
  
  
  
  
24. Soy products (tofu, edamame) (100 g) 
  
  
  
  
  
  
  
  
  
25. Potatoes (boiled, baked) (1 medium) 
  
  
  
  
  
  
  
  
  
26. French fries or potato chips (1 portion) 
  
  
  
  
  
  
  
  
  
27. Pickled vegetables (1 serving) 
  
  
  
  
  
  
  
  
  
28. Sofrito (tomato/garlic/onion sautéed in 
olive oil) (1 serving) 
  
  
  
  
  
  
  
  
  
Section III: Cereals & Bread (Items 29–36)  

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Code: IIBSP-DDM-2023-166 
Version 4 Date: 27/06/2024 
29. Whole-grain bread (1 slice) 
  
  
  
  
  
  
  
  
  
30. Refined-grain bread (1 slice) 
  
  
  
  
  
  
  
  
  
31. Whole-grain rice, pasta, couscous (1 cup 
cooked) 
  
  
  
  
  
  
  
  
  
32. Refined-grain rice, pasta, couscous (1 cup 
cooked) 
  
  
  
  
  
  
  
  
  
33. Breakfast cereals (high-fiber) (30 g) 
  
  
  
  
  
  
  
  
  
34. Sweetened breakfast cereals (30 g) 
  
  
  
  
  
  
  
  
  
35. Oats or muesli (30 g) 
  
  
  
  
  
  
  
  
  
36. Other grains (quinoa, wheat berries) (1 
cup cooked) 
  
  
  
  
  
  
  
  
  
Section IV: Dairy (Items 37–43)  
37. Whole-milk yogurt or rice pudding 
(125 g) 
  
  
  
  
  
  
  
  
  
38. Skim- or semi-skimmed-milk yogurt 
(125 g) 
  
  
  
  
  
  
  
  
  
39. Whole-milk (1 glass, 200 mL) 
  
  
  
  
  
  
  
  
  
40. Skim- or semi-skimmed-milk (1 glass, 
200 mL) 
  
  
  
  
  
  
  
  
  
41. Cheese — hard/semi-hard (30 g) 
  
  
  
  
  
  
  
  
  
42. Fresh cheese (cottage, ricotta) (30 g) 
  
  
  
  
  
  
  
  
  
43. Fermented milk drinks (kefir, ayran) 
(200 mL) 
  
  
  
  
  
  
  
  
  
Section V: Meats & Eggs (Items 44–58)  
44. White meat (chicken, turkey, rabbit) — 1 
portion (100–125 g) 
  
  
  
  
  
  
  
  
  
45. Red meat (beef, pork, lamb) — 1 portion 
(100–125 g) 
  
  
  
  
  
  
  
  
  
46. Liver or other organ meats — 1 portion 
(100–125 g) 
  
  
  
  
  
  
  
  
  
47. Hamburgers (beef, pork, chicken) — 1 
unit 
  
  
  
  
  
  
  
  
  
48. Sausages (chorizo, salami, etc.) — 1 
portion (50 g) 
  
  
  
  
  
  
  
  
  
49. Bacon, pancetta — 1 slice 
  
  
  
  
  
  
  
  
  
50. 
Cold 
cuts 
(ham, 
turkey 
breast, 
mortadella) — 1 slice 
  
  
  
  
  
  
  
  
  
51. Canned meat (corned beef, luncheon 
meat) — 1 portion (50–75 g) 
  
  
  
  
  
  
  
  
  
52. Meatballs — 1 unit 
  
  
  
  
  
  
  
  
  
53. Cooked meat (e.g., stews) — 1 portion 
  
  
  
  
  
  
  
  
  
54. Breaded or fried meat — 1 portion (100–
125 g) 
  
  
  
  
  
  
  
  
  
55. Eggs — 1 unit 
  
  
  
  
  
  
  
  
  
56. Omelet — 1 portion 
  
  
  
  
  
  
  
  
  
57. Scrambled eggs or eggs with vegetables 
— 1 portion 
  
  
  
  
  
  
  
  
  
58. Boiled or fried egg — 1 unit 
  
  
  
  
  
  
  
  
  
Section VI: Fish & Seafood (Items 59–67)  
59. White fish (hake, cod, etc.) — 1 portion 
(100–150 g) 
  
  
  
  
  
  
  
  
  

21 
Code: IIBSP-DDM-2023-166 
Version 4 Date: 27/06/2024 
60. Oily fish (salmon, sardines, mackerel) — 1 
portion (100–150 g) 
  
  
  
  
  
  
  
  
  
61. Salted or smoked fish (cod, salmon, 
anchovies) — 1 portion (50 g) 
  
  
  
  
  
  
  
  
  
62. Shellfish (mussels, shrimp, clams) — 1 
portion (4–5 units) 
  
  
  
  
  
  
  
  
  
63. Canned tuna — 1 small can (80–100 g) 
  
  
  
  
  
  
  
  
  
64. Canned sardines or mackerel — 1 small 
can (80–100 g) 
  
  
  
  
  
  
  
  
  
65. Fish sticks or breaded fish — 1 unit 
  
  
  
  
  
  
  
  
  
66. Fish soup or stew — 1 portion 
  
  
  
  
  
  
  
  
  
67. Surimi or imitation crab — 1 stick (25 g) 
  
  
  
  
  
  
  
  
  
Section VII: Oils, Fats & Sauces (Items 68–77)  
68. Extra virgin olive oil — 1 tablespoon 
(10 mL) 
  
  
  
  
  
  
  
  
  
69. Olive oil (not extra virgin) — 1 tablespoon 
  
  
  
  
  
  
  
  
  
70. Sunflower, corn or soybean oil — 1 
tablespoon 
  
  
  
  
  
  
  
  
  
71. Butter — 1 portion (12 g) 
  
  
  
  
  
  
  
  
  
72. Margarine — 1 portion (12 g) 
  
  
  
  
  
  
  
  
  
73. Mayonnaise — 1 tablespoon 
  
  
  
  
  
  
  
  
  
74. Cream (liquid or whipped) — 1 
tablespoon 
  
  
  
  
  
  
  
  
  
75. 
Other 
sauces 
(ketchup, 
mustard, 
barbecue) — 1 tablespoon 
  
  
  
  
  
  
  
  
  
76. Pesto, aioli or other oil-based sauces — 1 
tablespoon 
  
  
  
  
  
  
  
  
  
77. Lard or animal fat — 1 tablespoon 
  
  
  
  
  
  
  
  
  
Section VIII: Beverages (Items 78–94)  
78. Coffee — 1 cup 
  
  
  
  
  
  
  
  
  
79. Decaffeinated coffee — 1 cup 
  
  
  
  
  
  
  
  
  
80. Tea (green, black, etc.) — 1 cup 
  
  
  
  
  
  
  
  
  
81. Herbal teas (chamomile, mint, etc.) — 1 
cup 
  
  
  
  
  
  
  
  
  
82. Milkshakes or flavored milk drinks — 1 
glass (200 mL) 
  
  
  
  
  
  
  
  
  
83. Soft drinks with sugar — 1 can (330 mL) 
  
  
  
  
  
  
  
  
  
84. Soft drinks without sugar (diet/light) — 1 
can (330 mL) 
  
  
  
  
  
  
  
  
  
85. Bottled fruit juice (not freshly squeezed) 
— 1 glass (200 mL) 
  
  
  
  
  
  
  
  
  
86. Alcohol-free beer — 1 can/bottle 
(330 mL) 
  
  
  
  
  
  
  
  
  
87. Beer — 1 can/bottle (330 mL) 
  
  
  
  
  
  
  
  
  
88. Red wine (young) — 100 mL glass 
  
  
  
  
  
  
  
  
  
89. Red wine (aged/reserve) — 50 mL glass 
  
  
  
  
  
  
  
  
  
90. White or rosé wine — 100 mL glass 
  
  
  
  
  
  
  
  
  
91. Cava or sparkling wine — 100 mL glass 
  
  
  
  
  
  
  
  
  
92. Liquor (e.g., whiskey, gin, rum) — 30 mL 
shot 
  
  
  
  
  
  
  
  
  

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Code: IIBSP-DDM-2023-166 
Version 4 Date: 27/06/2024 
93. Sweet liqueurs (Baileys, anise, vermouth) 
— 30 mL shot 
  
  
  
  
  
  
  
  
  
94. Mixed alcoholic drinks (cocktails, gin & 
tonic) — 1 glass 
  
  
  
  
  
  
  
  
  
Section IX: Sweets, Pastries & Snacks (Items 95–113)  
95. Pastries (croissants, doughnuts, etc.) — 1 
unit 
  
  
  
  
  
  
  
  
  
96. Cookies or biscuits — 1 unit or portion 
(30 g) 
  
  
  
  
  
  
  
  
  
97. Cakes (sponge cake, pie, etc.) — 1 slice 
  
  
  
  
  
  
  
  
  
98. Chocolate (milk or dark) — 1 portion 
(30 g) 
  
  
  
  
  
  
  
  
  
99. Chocolates with filling or nuts — 1 
portion (30 g) 
  
  
  
  
  
  
  
  
  
100. Candies, gummies or sweets — 1 
portion (30 g) 
  
  
  
  
  
  
  
  
  
101. Honey or jam — 1 tablespoon 
  
  
  
  
  
  
  
  
  
102. Ice cream — 1 scoop or small cup 
  
  
  
  
  
  
  
  
  
103. Puddings or custards — 1 portion 
  
  
  
  
  
  
  
  
  
104. Snack bars or energy bars — 1 unit 
  
  
  
  
  
  
  
  
  
105. Potato chips — 1 small bag (30 g) 
  
  
  
  
  
  
  
  
  
106. Salted nuts — 1 handful (30 g) 
  
  
  
  
  
  
  
  
  
107. Popcorn (ready-to-eat) — 1 portion 
(30 g) 
  
  
  
  
  
  
  
  
  
108. Crackers or breadsticks — 1 portion 
(30 g) 
  
  
  
  
  
  
  
  
  
109. Savory snacks (nachos, cheese balls, 
etc.) — 1 portion (30 g) 
  
  
  
  
  
  
  
  
  
110. Sugar cubes or teaspoons added to 
drinks — 1 unit 
  
  
  
  
  
  
  
  
  
111. Artificial sweeteners — 1 packet or dose 
  
  
  
  
  
  
  
  
  
112. Desserts made at home (custards, rice 
pudding) — 1 portion 
  
  
  
  
  
  
  
  
  
113. Diet or sugar-free sweets — 1 portion 
  
  
  
  
  
  
  
  
  
Section X: Miscellaneous (Items 114–137)  
114. Pizza (homemade or commercial) — 1 
slice or small unit 
  
  
  
  
  
  
  
  
  
115. Lasagna or cannelloni — 1 portion 
  
  
  
  
  
  
  
  
  
116. Stuffed pasta (ravioli, tortellini) — 1 
portion 
  
  
  
  
  
  
  
  
  
117. Prepared foods (frozen meals, ready 
dishes) — 1 portion 
  
  
  
  
  
  
  
  
  
118. Fried rice or noodles — 1 portion 
  
  
  
  
  
  
  
  
  
119. Couscous or bulgur — 1 portion 
  
  
  
  
  
  
  
  
  
120. Vegetable soup — 1 bowl 
  
  
  
  
  
  
  
  
  
121. Meat or chicken broth — 1 bowl 
  
  
  
  
  
  
  
  
  
122. Fish soup — 1 bowl 
  
  
  
  
  
  
  
  
  
123. Mixed salads with dressing — 1 bowl 
  
  
  
  
  
  
  
  
  
124. Mixed dishes (paella, fideuá) — 1 
portion 
  
  
  
  
  
  
  
  
  
125. Tapas or appetizers (small bites) — 1 
  
  
  
  
  
  
  
  
  

23 
Code: IIBSP-DDM-2023-166 
Version 4 Date: 27/06/2024 
portion 
126. Food eaten outside home (per week) 
  
  
  
  
  
  
  
  
  
127. Takeaway or fast food (per week) 
  
  
  
  
  
  
  
  
  
128. Vitamin supplements — 1 tablet or dose 
  
  
  
  
  
  
  
  
  
129. Mineral supplements — 1 tablet or dose 
  
  
  
  
  
  
  
  
  
130. Fiber supplements — 1 dose 
  
  
  
  
  
  
  
  
  
131. Protein powder or shakes — 1 dose 
  
  
  
  
  
  
  
  
  
132. Herbal or natural remedies — 1 dose 
  
  
  
  
  
  
  
  
  
133. Meal replacement drinks — 1 bottle 
(200–250 mL) 
  
  
  
  
  
  
  
  
  
134. Sports drinks (isotonic) — 1 bottle 
(500 mL) 
  
  
  
  
  
  
  
  
  
135. Energy drinks (Red Bull, Monster, etc.) 
— 1 can 
  
  
  
  
  
  
  
  
  
136. Artificial supplements or ergogenic aids 
— 1 dose 
  
  
  
  
  
  
  
  
  
137. Other food supplements not listed — 1 
dose