Pediatric ObesityOBIASITYNCT06312280
Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity
An observational study of Pediatric Obesity, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
In recent decades, the prevalence of obesity and overweight has dramatically increased globally, representing a serious problem for society and for the health system of many countries, estimating an impact of 2-8% on global health spending. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 6-17 years pediatric subjects with obesity or overweight
Who may be able to join
- Age between 6 and 17 years;
- BMI compatible with obesity or overweight according to IOTF criteria
- Signature of informed consent by parents/legal tutors.
Who cannot join
- Age below 6 years or over 18
- Previous diagnosis of diabetes mellitus type 2 already placed in dietary or pharmacological therapy
- Subjects already included in dieto-therapeutic regimen
- Obesity secondary to diseases: genetic (Prader Willi syndrome, Down syndrome); metabolic and endocrine (Cushing syndrome, hypothyroidism)
Trial locations and contacts
1 site in 1 country.
Italy1 site
SCDU Pediatria, AOU Maggiore della Carità
Novara, 28100
Simonetta Bellone, MD, +39-0321-660693, simonetta.bellone@med.uniupo.it
About this study
Official title: Obiasity Study: Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity
In recent decades, the prevalence of obesity and overweight has dramatically increased globally, representing a serious problem for society and for the health system of many countries, estimating an impact of 2-8% on global health spending. Obesity and overweight represent a problem not only for adults but also for children and adolescents: the latest data from the WHO estimate that about 340 million children and adolescents between 5 and 19 years are overweight or obese, data that increase drastically since 1975 from 4% of boys to 18% in 2016. (World Health Organization (WHO). The reduction and prevention of overweight and obesity in childhood is one of the main missions of public health at the global level, both for short-term and long-term implications. Recently, the importance of bioprothesiometric analysis (BIA) in the clinical routine has been evaluated, as it allows an estimation of body composition that would not otherwise be provided by the growth curves and the calculation of the Body Mass Index (BMI). In this study the investigators want to evaluate, in addition to the classic clinical parameters, the body composition of patients evaluated by means of an impedance balance (named TANITA MC780 MA P). With this study the investigators aim to investigate possible clinical and body composition changes in children and adolescents suffering from overweight and obesity with the ultimate aim of reducing cardio-metabolic risk factors related to it.
The objective of the study is the assessment of body composition, as an indicator of accuracy of lean mass, but especially of fat mass, of pediatric patients who are overweight and obesity in order to carry out a more complete evaluation of the clinical-metabolic condition for the prevention of cardiovascular risk.
The secondary objective is to assess the dietary compliance of the patients being studied and the possible correlation with the body composition.
Read the detailed description
MATERIALS AND METHODS
The study will include all children and adolescents who visit the SCDU (Struttura Complessa a Direzione Universitaria) of Pediatrics, Surgery of Endocrinology and Auxology of the Major Charity Hospital of Novara for first visit or checkup for excess weight between 1 January 2024 and 30 May 2024 of both sexes that meet the following criteria of inclusion:
Criteria for inclusion:
Age between 6 and 17 years; BMI compatible with obesity or overweight according to International Obesity Task Force (IOTF) criteria Signature of informed consent by parents/legal guardians.
Criteria for exclusion:
Age below 6 years or over 18 Previous diagnosis of diabetes mellitus type 2 already placed in dietary or pharmacological therapy Subjects already included in dieto-therapeutic regimen Obesity secondary to diseases: genetic (Prader Willi syndrome, Down syndrome); metabolic and endocrine (Cushing syndrome, hypothyroidism)
Informed consent After reading the study fact sheet, patients will only be enrolled after the signature of the informed consent form by both parents or the legal representative and the minor subjects recruited (see patient and parent/guardian information attached to the protocol).
Upon enlistment (V1), the subjects included will undergo a clinical examination in accordance with normal practice, in which a bioimpedance analysis for the assessment of body composition is provided. The impedance analysis will be carried out using TANITA MC-780MA balance.
After the bioimpedance analysis and the clinical visit, a food scheme based on the Mediterranean Diet will be delivered. The composition of the diet will be distributed as follows: 55-60% of carbohydrates (45-50% complex carbohydrates and no more than 10% of simple sugars), 25-30% of lipids and 15% of proteins. It will be studied in accordance with the Reference Nutrient and Energy Intake Levels (LARN) (Italian Society of Human Nutrition, 2014) guidelines.
Follow-up Patients will be evaluated at the time of enrollment (V1), after 3 months (V3) and after 6 months (V6) as per clinical practice.
At the recruitment visit (V1) the following demographic and medical history of the patient and family will be collected:
sex, gender, age (years), ethnicity, weight and length at birth, type and duration of breastfeeding, age of parents (years), family history of previous diseases (Arterial Hypertension, Dyslipidemia, Hepatic Steatosis, Diabetes (specify if type I or II and oral or insulin therapy) and cardiovascular pathology, the smoking habit of parents, presence of gestational maternal diabetes), socioeconomic level of the family nucleus.
At all times (V1,V3,V6) the following assessments will be made:
Anthropometric measurements Height Weight BMI and BMI standard deviation score (SDS) Growth percentile according to Cacciari curves Waist/hips circumference, waist/height ratio Bioimpedance Pa and heart rate Stadium of Tanner Eating habits and medical history Semi-quantitative food frequency questionnaire (24h recall) Questionnaire of adherence to the Mediterranean diet called Quality Index for Children and Adolescents (KIDMED) Questionnaire on daily physical activity (IPAQ)
Biochemical assessments will also be carried out at the beginning and end of the protocol (V1 and V6) according to normal clinical practice (basic blood chemistry and/or OGTT). The analysis will be carried out at the clinical biochemistry laboratory of the University hospital (AOU- Azienda Ospedaliero Universitaria) "Major of Charity" of Novara.
During the biochemical evaluations, two serum and two plasma samples will be taken for Asprosin, Irisin and Ghrelin for the research of new markers related to obesity and its complications. The analysis will be carried out at the Laboratory of Biochemistry of the University of Eastern Piedmont The determination of clinical parameters will be carried out locally at the clinic of Auxologia and Pediatric Endocrinology of the Pediatric Clinic of the Major Hospital of Charity of Novara, while the examination of the BIA will be carried out at the Endocrinology Clinic of the Major Hospital of Charity of Novara.
EXPECTED RESULTS It is expected a change in the body mass index based on the BMI z-score and an improvement in body composition after 6 months from the first visit and then from the implementation of the dietary scheme. In addition, an improvement in metabolic parameters is expected (insulin resistance, glycidic intolerance, dyslipidemia, hepatic steatosis)
- Conditions
- Pediatric Obesity
- Being tested
- Mediterranean diet
- Keywords
- pediatric, obesity, overweight, body composition
- Medical subject headings
- Pediatric Obesity, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietBehavioural
The composition of the diet will be distributed as follows: 55-60% of carbohydrates (45-50% complex carbohydrates and no more than 10% of simple sugars), 25-30% of lipids and 15% of proteins. It will be studied in accordance with the LARN (Italian Society of Human Nutrition, 2014) guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric children and adolescents with obesity or overweight | The study will include all children and adolescents who visit the SCDU of Pediatrics, Surgery of Endocrinology and Auxology of the Major Charity Hospital of Novara for first visit or checkup for excess weight between 1 January 2024 and 30 May 2024 of both sexes that meet the following criteria of inclusion:
Criteria for inclusion:
Age between 6 and 17 years; BMI compatible with obesity or overweight according to IOTF criteria (6) Signature of informed consent by parents/legal guardians.
Criteria for exclusion:
Age below 6 years or over 18 Previous diagnosis of diabetes mellitus type 2 already placed in dietary or pharmacological therapy Subjects already included in dieto-therapeutic regimen Obesity secondary to diseases: genetic (Prader Willi syndrome, Down syndrome); metabolic and endocrine (Cushing syndrome, hypothyroidism) Receives: Behavioral: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body composition
evaluation of body composition with Bioimpendence analysis (BIA)
Measured: Change of body composition at baseline (V0) and after 3 months (V3) and 6 months (V6)
Secondary outcomes (2)
Dietary compliance with questionnaires
Assessment of food conformity, in particular adherence to the Mediterranean diet, through KIDMED questionnaires. The questionnaire will provide a value equivalent to + or - 1 depending on the positive (+1) or negative (-1) response to the questions. Adding up the values will give a final result from which to determine if the current diet is Mediterranean or very different. The scale of values is as follows: less than or equal to 3 indicates a low adhesion, between 4 and 7 an average adhesion and higher than 8 a high adherence to a Mediterranean diet.
Measured: Change of dietary compliance at baseline (V0) and after 3 months (V3) and 6 months (V6)
Correlation between change in body composition (primary outcome) and dietary compliance (secondary outcome)
Subsequent correlation with the primary objective, so with the body composition measured through the analysis of bioimpedance. Observation between the adherence to the diet and the change in body composition, measured through the BIA analysis.
Measured: Change of dietary compliance at baseline (V0) and after 3 months (V3) and 6 months (V6). Change of BMI at baseline (V0) and after 3 months (V3) and 6 months (V6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simonetta Bellone, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Simonetta Bellone, MD, Principal investigator, AOU Maggiore della Carità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312280
- Sponsor's protocol ID
- CE342/2023
- Acronym
- OBIASITY
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grosso G, Marventano S, Yang J, Micek A, Pajak A, Scalfi L, Galvano F, Kales SN. A comprehensive meta-analysis on evidence of Mediterranean diet and cardiovascular disease: Are individual components equal? Crit Rev Food Sci Nutr. 2017 Oct 13;57(15):3218-3232. doi: 10.1080/10408398.2015.1107021.
PubMed 26528631Tremmel M, Gerdtham UG, Nilsson PM, Saha S. Economic Burden of Obesity: A Systematic Literature Review. Int J Environ Res Public Health. 2017 Apr 19;14(4):435. doi: 10.3390/ijerph14040435.
PubMed 28422077Valerio G, Maffeis C, Saggese G, Ambruzzi MA, Balsamo A, Bellone S, Bergamini M, Bernasconi S, Bona G, Calcaterra V, Canali T, Caroli M, Chiarelli F, Corciulo N, Crino A, Di Bonito P, Di Pietrantonio V, Di Pietro M, Di Sessa A, Diamanti A, Doria M, Fintini D, Franceschi R, Franzese A, Giussani M, Grugni G, Iafusco D, Iughetti L, Lamborghini A, Licenziati MR, Limauro R, Maltoni G, Manco M, Reggiani LM, Marcovecchio L, Marsciani A, Del Giudice EM, Morandi A, Morino G, Moro B, Nobili V, Perrone L, Picca M, Pietrobelli A, Privitera F, Purromuto S, Ragusa L, Ricotti R, Santamaria F, Sartori C, Stilli S, Street ME, Tanas R, Trifiro G, Umano GR, Vania A, Verduci E, Zito E. Diagnosis, treatment and prevention of pediatric obesity: consensus position statement of the Italian Society for Pediatric Endocrinology and Diabetology and the Italian Society of Pediatrics. Ital J Pediatr. 2018 Jul 31;44(1):88. doi: 10.1186/s13052-018-0525-6.
PubMed 30064525Khalil SF, Mohktar MS, Ibrahim F. The theory and fundamentals of bioimpedance analysis in clinical status monitoring and diagnosis of diseases. Sensors (Basel). 2014 Jun 19;14(6):10895-928. doi: 10.3390/s140610895.
PubMed 24949644Cacciari E, Milani S, Balsamo A, Spada E, Bona G, Cavallo L, Cerutti F, Gargantini L, Greggio N, Tonini G, Cicognani A. Italian cross-sectional growth charts for height, weight and BMI (2 to 20 yr). J Endocrinol Invest. 2006 Jul-Aug;29(7):581-93. doi: 10.1007/BF03344156.
PubMed 16957405Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.
PubMed 15482620Hagstromer M, Bergman P, De Bourdeaudhuij I, Ortega FB, Ruiz JR, Manios Y, Rey-Lopez JP, Phillipp K, von Berlepsch J, Sjostrom M; HELENA Study Group. Concurrent validity of a modified version of the International Physical Activity Questionnaire (IPAQ-A) in European adolescents: The HELENA Study. Int J Obes (Lond). 2008 Nov;32 Suppl 5:S42-8. doi: 10.1038/ijo.2008.182.
PubMed 19011653Chen PS, Chang KC, Chang CH, Chen YT, Huang HW, Tsai SM, Yang HR, Tung YC, Wu WW, Chen HL. The effect of a multidisciplinary lifestyle modification program for obese and overweight children. J Formos Med Assoc. 2022 Sep;121(9):1773-1785. doi: 10.1016/j.jfma.2022.01.011. Epub 2022 Jan 29.
PubMed 35094911
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obiasity Study: Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06312280
- Acronym / sponsor ID
- OBIASITY / CE342/2023
- Conditions
- Pediatric Obesity
- Keywords
- pediatric, obesity, overweight, body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 15 Mar 2024 (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.
In recent decades, the prevalence of obesity and overweight has dramatically increased globally, representing a serious problem for society and for the health system of many countries, estimating an impact of 2-8% on global health spending. Obesity and overweight represent a problem not only for adults but also for children and adolescents: the latest data from the WHO estimate that about 340 million children and adolescents between 5 and 19 years are overweight or obese, data that increase drastically since 1975 from 4% of boys to 18% in 2016. (World Health Organization (WHO). The reduction and prevention of overweight and obesity in childhood is one of the main missions of public health at the global level, both for short-term and long-term implications. Recently, the importance of bioprothesiometric analysis (BIA) in the clinical routine has been evaluated, as it allows an estimation of body composition that would not otherwise be provided by the growth curves and the calculation of the Body Mass Index (BMI). In this study the investigators want to evaluate, in addition to the classic clinical parameters, the body composition of patients evaluated by means of an impedance balance (named TANITA MC780 MA P). With this study the investigators aim to investigate possible clinical and body composition changes in children and adolescents suffering from overweight and obesity with the ultimate aim of reducing cardio-metabolic risk factors related to it.
The objective of the study is the assessment of body composition, as an indicator of accuracy of lean mass, but especially of fat mass, of pediatric patients who are overweight and obesity in order to carry out a more complete evaluation of the clinical-metabolic condition for the prevention of cardiovascular risk.
The secondary objective is to assess the dietary compliance of the patients being studied and the possible correlation with the body composition.
Detailed description
MATERIALS AND METHODS
The study will include all children and adolescents who visit the SCDU (Struttura Complessa a Direzione Universitaria) of Pediatrics, Surgery of Endocrinology and Auxology of the Major Charity Hospital of Novara for first visit or checkup for excess weight between 1 January 2024 and 30 May 2024 of both sexes that meet the following criteria of inclusion:
Criteria for inclusion:
Age between 6 and 17 years; BMI compatible with obesity or overweight according to International Obesity Task Force (IOTF) criteria Signature of informed consent by parents/legal guardians.
Criteria for exclusion:
Age below 6 years or over 18 Previous diagnosis of diabetes mellitus type 2 already placed in dietary or pharmacological therapy Subjects already included in dieto-therapeutic regimen Obesity secondary to diseases: genetic (Prader Willi syndrome, Down syndrome); metabolic and endocrine (Cushing syndrome, hypothyroidism)
Informed consent After reading the study fact sheet, patients will only be enrolled after the signature of the informed consent form by both parents or the legal representative and the minor subjects recruited (see patient and parent/guardian information attached to the protocol).
Upon enlistment (V1), the subjects included will undergo a clinical examination in accordance with normal practice, in which a bioimpedance analysis for the assessment of body composition is provided. The impedance analysis will be carried out using TANITA MC-780MA balance.
After the bioimpedance analysis and the clinical visit, a food scheme based on the Mediterranean Diet will be delivered. The composition of the diet will be distributed as follows: 55-60% of carbohydrates (45-50% complex carbohydrates and no more than 10% of simple sugars), 25-30% of lipids and 15% of proteins. It will be studied in accordance with the Reference Nutrient and Energy Intake Levels (LARN) (Italian Society of Human Nutrition, 2014) guidelines.
Follow-up Patients will be evaluated at the time of enrollment (V1), after 3 months (V3) and after 6 months (V6) as per clinical practice.
At the recruitment visit (V1) the following demographic and medical history of the patient and family will be collected:
sex, gender, age (years), ethnicity, weight and length at birth, type and duration of breastfeeding, age of parents (years), family history of previous diseases (Arterial Hypertension, Dyslipidemia, Hepatic Steatosis, Diabetes (specify if type I or II and oral or insulin therapy) and cardiovascular pathology, the smoking habit of parents, presence of gestational maternal diabetes), socioeconomic level of the family nucleus.
At all times (V1,V3,V6) the following assessments will be made:
Anthropometric measurements Height Weight BMI and BMI standard deviation score (SDS) Growth percentile according to Cacciari curves Waist/hips circumference, waist/height ratio Bioimpedance Pa and heart rate Stadium of Tanner Eating habits and medical history Semi-quantitative food frequency questionnaire (24h recall) Questionnaire of adherence to the Mediterranean diet called Quality Index for Children and Adolescents (KIDMED) Questionnaire on daily physical activity (IPAQ)
Biochemical assessments will also be carried out at the beginning and end of the protocol (V1 and V6) according to normal clinical practice (basic blood chemistry and/or OGTT). The analysis will be carried out at the clinical biochemistry laboratory of the University hospital (AOU- Azienda Ospedaliero Universitaria) "Major of Charity" of Novara.
During the biochemical evaluations, two serum and two plasma samples will be taken for Asprosin, Irisin and Ghrelin for the research of new markers related to obesity and its complications. The analysis will be carried out at the Laboratory of Biochemistry of the University of Eastern Piedmont The determination of clinical parameters will be carried out locally at the clinic of Auxologia and Pediatric Endocrinology of the Pediatric Clinic of the Major Hospital of Charity of Novara, while the examination of the BIA will be carried out at the Endocrinology Clinic of the Major Hospital of Charity of Novara.
EXPECTED RESULTS It is expected a change in the body mass index based on the BMI z-score and an improvement in body composition after 6 months from the first visit and then from the implementation of the dietary scheme. In addition, an improvement in metabolic parameters is expected (insulin resistance, glycidic intolerance, dyslipidemia, hepatic steatosis)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric children and adolescents with obesity or overweight | – | Behavioral: Mediterranean dietThe study will include all children and adolescents who visit the SCDU of Pediatrics, Surgery of Endocrinology and Auxology of the Major Charity Hospital of Novara for first visit or checkup for excess weight between 1 January 2024 and 30 May 2024 of both sexes that meet the following criteria of inclusion: Criteria for inclusion: Age between 6 and 17 years; BMI compatible with obesity or overweight according to IOTF criteria (6) Signature of informed consent by parents/legal guardians. Criteria for exclusion: Age below 6 years or over 18 Previous diagnosis of diabetes mellitus type 2 already placed in dietary or pharmacological therapy Subjects already included in dieto-therapeutic regimen Obesity secondary to diseases: genetic (Prader Willi syndrome, Down syndrome); metabolic and endocrine (Cushing syndrome, hypothyroidism) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 6-17 years pediatric subjects with obesity or overweight
Key inclusion criteria (3 listed)
- Age between 6 and 17 years;
- BMI compatible with obesity or overweight according to IOTF criteria
- Signature of informed consent by parents/legal tutors.
Key exclusion criteria (4 listed)
- Age below 6 years or over 18
- Previous diagnosis of diabetes mellitus type 2 already placed in dietary or pharmacological therapy
- Subjects already included in dieto-therapeutic regimen
- Obesity secondary to diseases: genetic (Prader Willi syndrome, Down syndrome); metabolic and endocrine (Cushing syndrome, hypothyroidism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean dietThe composition of the diet will be distributed as follows: 55-60% of carbohydrates (45-50% complex carbohydrates and no more than 10% of simple sugars), 25-30% of lipids and 15% of proteins. It will be studied in accordance with the LARN (Italian Society of Human Nutrition, 2014) guidelines. | Behavioural | Pediatric children and adolescents with obesity or overweight |
Primary outcome
Change in Body composition
Time frame: Change of body composition at baseline (V0) and after 3 months (V3) and 6 months (V6)
evaluation of body composition with Bioimpendence analysis (BIA)
2 secondary outcomes
Dietary compliance with questionnaires
Time frame: Change of dietary compliance at baseline (V0) and after 3 months (V3) and 6 months (V6)
Correlation between change in body composition (primary outcome) and dietary compliance (secondary outcome)
Time frame: Change of dietary compliance at baseline (V0) and after 3 months (V3) and 6 months (V6). Change of BMI at baseline (V0) and after 3 months (V3) and 6 months (V6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 26528631Grosso G, Marventano S, Yang J, Micek A, Pajak A, Scalfi L, Galvano F, Kales SN. A comprehensive meta-analysis on evidence of Mediterranean diet and cardiovascular disease: Are individual components equal? Crit Rev Food Sci Nutr. 2017 Oct 13;57(15):3218-3232. doi: 10.1080/10408398.2015.1107021.
- Background: PubMed 28422077Tremmel M, Gerdtham UG, Nilsson PM, Saha S. Economic Burden of Obesity: A Systematic Literature Review. Int J Environ Res Public Health. 2017 Apr 19;14(4):435. doi: 10.3390/ijerph14040435.
- Background: PubMed 30064525Valerio G, Maffeis C, Saggese G, Ambruzzi MA, Balsamo A, Bellone S, Bergamini M, Bernasconi S, Bona G, Calcaterra V, Canali T, Caroli M, Chiarelli F, Corciulo N, Crino A, Di Bonito P, Di Pietrantonio V, Di Pietro M, Di Sessa A, Diamanti A, Doria M, Fintini D, Franceschi R, Franzese A, Giussani M, Grugni G, Iafusco D, Iughetti L, Lamborghini A, Licenziati MR, Limauro R, Maltoni G, Manco M, Reggiani LM, Marcovecchio L, Marsciani A, Del Giudice EM, Morandi A, Morino G, Moro B, Nobili V, Perrone L, Picca M, Pietrobelli A, Privitera F, Purromuto S, Ragusa L, Ricotti R, Santamaria F, Sartori C, Stilli S, Street ME, Tanas R, Trifiro G, Umano GR, Vania A, Verduci E, Zito E. Diagnosis, treatment and prevention of pediatric obesity: consensus position statement of the Italian Society for Pediatric Endocrinology and Diabetology and the Italian Society of Pediatrics. Ital J Pediatr. 2018 Jul 31;44(1):88. doi: 10.1186/s13052-018-0525-6.
- Background: PubMed 24949644Khalil SF, Mohktar MS, Ibrahim F. The theory and fundamentals of bioimpedance analysis in clinical status monitoring and diagnosis of diseases. Sensors (Basel). 2014 Jun 19;14(6):10895-928. doi: 10.3390/s140610895.
- Background: PubMed 16957405Cacciari E, Milani S, Balsamo A, Spada E, Bona G, Cavallo L, Cerutti F, Gargantini L, Greggio N, Tonini G, Cicognani A. Italian cross-sectional growth charts for height, weight and BMI (2 to 20 yr). J Endocrinol Invest. 2006 Jul-Aug;29(7):581-93. doi: 10.1007/BF03344156.
- Background: PubMed 15482620Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.
- Background: PubMed 19011653Hagstromer M, Bergman P, De Bourdeaudhuij I, Ortega FB, Ruiz JR, Manios Y, Rey-Lopez JP, Phillipp K, von Berlepsch J, Sjostrom M; HELENA Study Group. Concurrent validity of a modified version of the International Physical Activity Questionnaire (IPAQ-A) in European adolescents: The HELENA Study. Int J Obes (Lond). 2008 Nov;32 Suppl 5:S42-8. doi: 10.1038/ijo.2008.182.
- Background: PubMed 35094911Chen PS, Chang KC, Chang CH, Chen YT, Huang HW, Tsai SM, Yang HR, Tung YC, Wu WW, Chen HL. The effect of a multidisciplinary lifestyle modification program for obese and overweight children. J Formos Med Assoc. 2022 Sep;121(9):1773-1785. doi: 10.1016/j.jfma.2022.01.011. Epub 2022 Jan 29.
- Okkio alla salute DataLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Simonetta Bellone, MD principal investigator
AOU Maggiore della Carità
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 Pediatric Obesity, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simonetta Bellone, MD (+39-0321-660693, simonetta.bellone@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body composition (time frame: Change of body composition at baseline (V0) and after 3 months (V3) and 6 months (V6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312280, which also lists 8 linked publications.
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 19 Mar 2024.