Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-03
Study Completion Date
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Alongside efforts in public health and policy to reverse the childhood obesity epidemic, medical providers seek to play effective roles in prevention and treatment. Limited interventional studies with effective long-term maintenance of weight loss in children are available. Moreover, interventions should focus on modifying lifestyle, by improving also ludic educational training. In fact, the knowledge, attitudes, behaviors and skills developed through effective health programs may result in a better quality of life and empower children to make correct choices to promote the health of the individual the family and the community. For this reason, in a cohort of obese pediatric subjects with visceral adiposity, the aim of the study is to assess the efficacy of an educational training inspired to Mediterranean diet and based on gamification (as "The Mediterranean Goose") with respect to a conventional treatment on weight loss and improvement of cardio-metabolic risk factors.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lifestyle Interventions and Metabolic Profile in Obese Children
NCT03728621
Childhood Obesity
Obesity
Pediatric Obesity
+3 more
COMPLETED
NA
Therapeutic Education Groups for Childhood Obesity
NCT06239662
Childhood Obesity
COMPLETED
NA
Nutrition Study for School Age Children
NCT00620152
Obesity
COMPLETED
NA
Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity
NCT06312280
Pediatric Obesity
NOT_YET_RECRUITING
Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters
NCT01656928
Obesity
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study design: A single-center pilot open-label randomized control trial. Population: The study will comprise a total of 60 subjects of both sexes, between 10 and 18 years of age, obese, according to the IOTF criteria (Cole TJ et al., 2000) and with visceral adiposity, as waist circumference ≥ 90th percentile (Cook S et al., 2003 - Cruz ML, Goran MI, 2004 - de Ferranti SD et al., 2004), diet naïve or with failure of weight loss (defined as -1 kg/m2 BMI in 1 year).
Inclusion/ Exclusion criteria (see Eligibility Criteria). Intervention: Patients will be randomized in a open-label, into two groups homogeneous for number and sex of the subjects. One group (group SD) will receive Standard Diet according to routine care and practice, and one group (group SD+MSD) will receive a standard diet according to routine clinical practice + a 30 minutes Mediterranean-Style Diet educational training with explanation of Mediterranean pyramid + gamification to Mediterranean diet inside the Hospital and at home throughout "The Mediterranean Goose".
Dietary restriction: Thestandard diet will be distributed with 55-60% of carbohydrates (45-50% complex and no more than 10% refined and processed sugars), 25-30% lipids and 15% proteins, and will be performedin accordance with the calories of an isocaloric balanced diet calculated throughout the Italian LARN Guidelines for age and gender (Società Italiana di Nutrizione Umana, 2014), inspired to Mediterranean pyramid.The standard diet will be given as diet plans in writing, after explanation by a well-trained and experienced clinical paediatric endocrinologist.
Education in Hospital: As well as receiving the aforementioned recommendations, the SD+MSD group will also receive a simple visual guide of Mediterranean food pyramid explained by a dietitian/nutritionist for 30 minutes (Bach-Faig A et al., 2011).
Gamification: The MSD Group will be involved inside the Hospital in an educational and playful training playing to "The Mediterranean Goose" in the ludic area of the Pediatric Department; this game has been proposed in an educational project known as "Mediterranean diet and enhancement of traditional foodstuff - MedDiet", founded by European Union in the framework of the ENPI CBC Mediterranean Sea Basin Programme (www.med-diet.eu). This material will be given to the family for continue to play also at home.
Physical activity: all subjects will receive general recommendations about performing physical activity. Exercise will be conducted daily and will consist of 30 minutes of aerobic physical activity.
Randomization: Alternately per week, participants will be randomly assigned in a 1:1 to one of the two dietary intervention groups.
Timing: Patients will be evaluated firstly at time of enrollment (V0) and, during the first 2 weeks of study (V1), biochemical and ultrasound evaluations will be completed. During the year of intervention, patients will be evaluated after 3 months, 6 months and 12 months (V2, V3, V4).The following anthropometric measures, biochemical and ultrasound evaluations and questionnaires will be obtained:
1. Anthropometric measures:
* height (V0, V2, V3, V4);
* weight (V0, V2, V3, V4);
* body mass index (BMI; Kg/m2) (V0, V2, V3, V4);
* waist and hip circumferences (V0, V2, V3, V4) for the calculation of the following ratios: waist/hip, waist/height;
* Tanner stage (V0, V2, V3, V4) (Tanner JM, 1961);
* blood pressure and heart rate (V0, V2, V3, V4).
2. Biochemical evaluations (after a 12-h overnight fast): CBC with formula, serum insulin-like growth factor 1 (IGF1, ng/mL), 25-hydroxy (OH) vitamin D (ng/mL), uric acid (mg/dL), alkaline phosphatase (U/L), ACTH (pg/mL), cortisol (microg/dL), TSH (uuI/mL), fT4 (ng/dL) (V1, V3, V4); aspartate aminotransferase (AST, IU/L), alanine aminotransferase (ALT, IU/L); AST-to-ALT ratio will be calculated as the ratio of AST (IU/L) and ALT(IU/L)(V1, V3, V4); serum creatinine concentration (mg/dL) will be measured with the enzymatic method; according to the NKF-K/DOQI Guidelines for CKD in children and adolescents (Hogg RJ et al., 2003), the eGFR will be calculated using updated Schwartz's formula (Schwartz GJ et al., 2009): eGFR (mL/min/1.73 m2) = \[0.413 x patient's height (cm)\] / serum creatinine (mg/dL)(V1, V3, V4); glucose (mg/dL), insulin (μUI/mL); insulin-resistance (IR) will be calculated using the formula of Homeostasis Model Assessment (HOMA)-IR: (insulin \[mU/L\] x glucose \[mmol/lL) / 22.5)(V1, V3, V4); lipid profile: total cholesterol (mg/dL), High-Density Lipoprotein (HDL)-cholesterol (mg/dL), triglycerides (mg/dL); Low-Density Lipoprotein (LDL)-cholesterol will be calculated by the Friedwald formula and non-HDL (nHDL)-cholesterol will be also calculated(V1, V3, V4); oral glucose tolerance test (OGTT: 1.75 g of glucose solution per kg, maximum 75 g) and samples willbe collected for the determination of glucose and insulin every 30 min. The area under the curve (AUC) for parameters after OGTT will be calculated according to the trapezoidal rule. Insulin sensitivity at fasting and during OGTT will be calculated as the formula of the Quantitative Insulin-Sensitivity Check Index (QUICKI) and Matsuda index (ISI). The stimulus for insulin secretion in the increment in plasma glucose as insulinogenic index will be calculated as the ratio of the changes in insulin and glucose concentration from 0 to 30 min (InsI). Βeta-cell compensatory capacity will be evaluated by the disposition index defined as the product of the ISI and InsI (DI) (Kahn SE et al., 1993)(V1, V4); a collection at rest of first-morning urine sample. Physical and chemical urinalysis; urine albumin (mg/L) will be determined by an advanced immunoturbidimetric assay and urine creatinine (mg/dL) will be measured using the enzymatic method. Urine albumin to creatinine ratio (u-ACR - mg/g), will be calculated using the following formula: \[urine albumin (mg/dL) / urine creatinine (mg/dL)\] x 1000. For these calculations both albumin and creatinine will be in the same unit. The subjects whose urine will be found positive, they will undergo a collection of two more samples and will be considered the u-ACR mean value of these (V1, V3, V4).
3. Ultrasound evaluations:
* liver ultrasound(V1, V4);
* echocardiography and carotid sonography(V1, V4).
4. Nutritional and physical activity measurements:
* KIDMED questionnaire for children and adolescents; the index comprises 16 yes or no questions (Serra-Majem L et al., 2004), and the total score of the KIDMED index ranged from -4 to 12 and is classified into 3 levels: 1)≥8: optimal Mediterranean diet; 2) 4-7: improvement is needed to adjust intake to the Mediterranean diet; 3) ≤3: very low diet quality; the Italian version is reported and approved by Istituto Superiore Sanità in Rapporti ISTISAN 12/42(Istituto Superiore della Sanità, Rapporti ISTISAN 12/42, 2012)(V0, V2, V3, V4);
* the Food Frequency Questionnaire section of the Children's Eating Habits Questionnaire (CEHQ-FFQ), performed by Identification and prevention of Dietary and lifestyle-induced health Effects In Children and infantS (IDEFICS) study, on which parents or other caregivers will be asked to report the number of meals the children usually consumed at home or at other people's homes, such as of grandparents and friends, in a typical week of the previous month (Huybrechts I et al., 2011) (V0, V2, V3, V4);
* 24-hour recall and a list of all foods and constituents included in the Dietary Inflammatory Index (DII) along with the respective adjusted score will be evaluated. Food- and constituent-specific scores will be multiplied by the intake for each subject. and then will be summed to create the overall Inflammatory Index score (Cavicchia PP et al., 2009 - Shivappa N et al., 2014) (V0, V2, V3, V4);
* the Mediterranean Adequacy Index (MAI) will be obtained by dividing the sum of the percentage of total energy from typical Mediterranean food groups by the sum of the percentage of total energy from non-typical Mediterranean food groups, according to the following equation (Alberti-Fidanza A, Fidanza F, 2004) (V0, V2, V3, V4);
* the International Physical Activity Questionnaire (IPAQ) developed, validated for Italian adolescents (IPAQ-A) will be developed; It covers four domains of physical activity: (1) school-related physical activity, including activity during physical education classes and breaks, (2) transportation, (3) housework and (4) leisure time (Hagstromer M et al., 2008 - Mannocci A et al, Accepted to Minerva Pediatrica) (V0, V2, V3, V4).
Outcomes (see Outcome Measures). Information retrieval: A case report form (CRF) will be completed for each subject included in the study. The source documents will be the hospital's or the physician's chart.
Statistical e sample size: A sample of 60 individuals (30 in each group) has been estimated to be sufficient to demonstrate a difference of 0.4kg/m2 in BMISDS with a SD of 0.65 (Prodam F et al, 2013) with 90% power and a significance level of 95% and a drop-out rate of 20% using the Student test. Statistical significance will be assumed at P\< 0.05. The statistical analysis will be performed with SPSS for Windows version 17.0 (SPSS Inc., Chicago, IL, USA).
Organization characteristics: The study will be conducted at the Pediatric Endocrine Service of Division of Pediatrics, Department of Health Sciences, University of Piemonte Orientale, in Novara.
All blood samples will be measured evaluated using standardized methods in the Hospital's Chemistry Laboratory, previously described (Prodam F et al., 2014 - Prodam F et al., 2016).
Good Clinical Practice: The protocol will be conducted in accordance with the declaration of Helsinki. Informed consent will be obtained from all parents prior to the evaluations after careful explanations to each patient.
Inclusion/ Exclusion criteria (see Eligibility Criteria). Intervention: Patients will be randomized in a open-label, into two groups homogeneous for number and sex of the subjects. One group (group SD) will receive Standard Diet according to routine care and practice, and one group (group SD+MSD) will receive a standard diet according to routine clinical practice + a 30 minutes Mediterranean-Style Diet educational training with explanation of Mediterranean pyramid + gamification to Mediterranean diet inside the Hospital and at home throughout "The Mediterranean Goose".
Dietary restriction: Thestandard diet will be distributed with 55-60% of carbohydrates (45-50% complex and no more than 10% refined and processed sugars), 25-30% lipids and 15% proteins, and will be performedin accordance with the calories of an isocaloric balanced diet calculated throughout the Italian LARN Guidelines for age and gender (Società Italiana di Nutrizione Umana, 2014), inspired to Mediterranean pyramid.The standard diet will be given as diet plans in writing, after explanation by a well-trained and experienced clinical paediatric endocrinologist.
Education in Hospital: As well as receiving the aforementioned recommendations, the SD+MSD group will also receive a simple visual guide of Mediterranean food pyramid explained by a dietitian/nutritionist for 30 minutes (Bach-Faig A et al., 2011).
Gamification: The MSD Group will be involved inside the Hospital in an educational and playful training playing to "The Mediterranean Goose" in the ludic area of the Pediatric Department; this game has been proposed in an educational project known as "Mediterranean diet and enhancement of traditional foodstuff - MedDiet", founded by European Union in the framework of the ENPI CBC Mediterranean Sea Basin Programme (www.med-diet.eu). This material will be given to the family for continue to play also at home.
Physical activity: all subjects will receive general recommendations about performing physical activity. Exercise will be conducted daily and will consist of 30 minutes of aerobic physical activity.
Randomization: Alternately per week, participants will be randomly assigned in a 1:1 to one of the two dietary intervention groups.
Timing: Patients will be evaluated firstly at time of enrollment (V0) and, during the first 2 weeks of study (V1), biochemical and ultrasound evaluations will be completed. During the year of intervention, patients will be evaluated after 3 months, 6 months and 12 months (V2, V3, V4).The following anthropometric measures, biochemical and ultrasound evaluations and questionnaires will be obtained:
1. Anthropometric measures:
* height (V0, V2, V3, V4);
* weight (V0, V2, V3, V4);
* body mass index (BMI; Kg/m2) (V0, V2, V3, V4);
* waist and hip circumferences (V0, V2, V3, V4) for the calculation of the following ratios: waist/hip, waist/height;
* Tanner stage (V0, V2, V3, V4) (Tanner JM, 1961);
* blood pressure and heart rate (V0, V2, V3, V4).
2. Biochemical evaluations (after a 12-h overnight fast): CBC with formula, serum insulin-like growth factor 1 (IGF1, ng/mL), 25-hydroxy (OH) vitamin D (ng/mL), uric acid (mg/dL), alkaline phosphatase (U/L), ACTH (pg/mL), cortisol (microg/dL), TSH (uuI/mL), fT4 (ng/dL) (V1, V3, V4); aspartate aminotransferase (AST, IU/L), alanine aminotransferase (ALT, IU/L); AST-to-ALT ratio will be calculated as the ratio of AST (IU/L) and ALT(IU/L)(V1, V3, V4); serum creatinine concentration (mg/dL) will be measured with the enzymatic method; according to the NKF-K/DOQI Guidelines for CKD in children and adolescents (Hogg RJ et al., 2003), the eGFR will be calculated using updated Schwartz's formula (Schwartz GJ et al., 2009): eGFR (mL/min/1.73 m2) = \[0.413 x patient's height (cm)\] / serum creatinine (mg/dL)(V1, V3, V4); glucose (mg/dL), insulin (μUI/mL); insulin-resistance (IR) will be calculated using the formula of Homeostasis Model Assessment (HOMA)-IR: (insulin \[mU/L\] x glucose \[mmol/lL) / 22.5)(V1, V3, V4); lipid profile: total cholesterol (mg/dL), High-Density Lipoprotein (HDL)-cholesterol (mg/dL), triglycerides (mg/dL); Low-Density Lipoprotein (LDL)-cholesterol will be calculated by the Friedwald formula and non-HDL (nHDL)-cholesterol will be also calculated(V1, V3, V4); oral glucose tolerance test (OGTT: 1.75 g of glucose solution per kg, maximum 75 g) and samples willbe collected for the determination of glucose and insulin every 30 min. The area under the curve (AUC) for parameters after OGTT will be calculated according to the trapezoidal rule. Insulin sensitivity at fasting and during OGTT will be calculated as the formula of the Quantitative Insulin-Sensitivity Check Index (QUICKI) and Matsuda index (ISI). The stimulus for insulin secretion in the increment in plasma glucose as insulinogenic index will be calculated as the ratio of the changes in insulin and glucose concentration from 0 to 30 min (InsI). Βeta-cell compensatory capacity will be evaluated by the disposition index defined as the product of the ISI and InsI (DI) (Kahn SE et al., 1993)(V1, V4); a collection at rest of first-morning urine sample. Physical and chemical urinalysis; urine albumin (mg/L) will be determined by an advanced immunoturbidimetric assay and urine creatinine (mg/dL) will be measured using the enzymatic method. Urine albumin to creatinine ratio (u-ACR - mg/g), will be calculated using the following formula: \[urine albumin (mg/dL) / urine creatinine (mg/dL)\] x 1000. For these calculations both albumin and creatinine will be in the same unit. The subjects whose urine will be found positive, they will undergo a collection of two more samples and will be considered the u-ACR mean value of these (V1, V3, V4).
3. Ultrasound evaluations:
* liver ultrasound(V1, V4);
* echocardiography and carotid sonography(V1, V4).
4. Nutritional and physical activity measurements:
* KIDMED questionnaire for children and adolescents; the index comprises 16 yes or no questions (Serra-Majem L et al., 2004), and the total score of the KIDMED index ranged from -4 to 12 and is classified into 3 levels: 1)≥8: optimal Mediterranean diet; 2) 4-7: improvement is needed to adjust intake to the Mediterranean diet; 3) ≤3: very low diet quality; the Italian version is reported and approved by Istituto Superiore Sanità in Rapporti ISTISAN 12/42(Istituto Superiore della Sanità, Rapporti ISTISAN 12/42, 2012)(V0, V2, V3, V4);
* the Food Frequency Questionnaire section of the Children's Eating Habits Questionnaire (CEHQ-FFQ), performed by Identification and prevention of Dietary and lifestyle-induced health Effects In Children and infantS (IDEFICS) study, on which parents or other caregivers will be asked to report the number of meals the children usually consumed at home or at other people's homes, such as of grandparents and friends, in a typical week of the previous month (Huybrechts I et al., 2011) (V0, V2, V3, V4);
* 24-hour recall and a list of all foods and constituents included in the Dietary Inflammatory Index (DII) along with the respective adjusted score will be evaluated. Food- and constituent-specific scores will be multiplied by the intake for each subject. and then will be summed to create the overall Inflammatory Index score (Cavicchia PP et al., 2009 - Shivappa N et al., 2014) (V0, V2, V3, V4);
* the Mediterranean Adequacy Index (MAI) will be obtained by dividing the sum of the percentage of total energy from typical Mediterranean food groups by the sum of the percentage of total energy from non-typical Mediterranean food groups, according to the following equation (Alberti-Fidanza A, Fidanza F, 2004) (V0, V2, V3, V4);
* the International Physical Activity Questionnaire (IPAQ) developed, validated for Italian adolescents (IPAQ-A) will be developed; It covers four domains of physical activity: (1) school-related physical activity, including activity during physical education classes and breaks, (2) transportation, (3) housework and (4) leisure time (Hagstromer M et al., 2008 - Mannocci A et al, Accepted to Minerva Pediatrica) (V0, V2, V3, V4).
Outcomes (see Outcome Measures). Information retrieval: A case report form (CRF) will be completed for each subject included in the study. The source documents will be the hospital's or the physician's chart.
Statistical e sample size: A sample of 60 individuals (30 in each group) has been estimated to be sufficient to demonstrate a difference of 0.4kg/m2 in BMISDS with a SD of 0.65 (Prodam F et al, 2013) with 90% power and a significance level of 95% and a drop-out rate of 20% using the Student test. Statistical significance will be assumed at P\< 0.05. The statistical analysis will be performed with SPSS for Windows version 17.0 (SPSS Inc., Chicago, IL, USA).
Organization characteristics: The study will be conducted at the Pediatric Endocrine Service of Division of Pediatrics, Department of Health Sciences, University of Piemonte Orientale, in Novara.
All blood samples will be measured evaluated using standardized methods in the Hospital's Chemistry Laboratory, previously described (Prodam F et al., 2014 - Prodam F et al., 2016).
Good Clinical Practice: The protocol will be conducted in accordance with the declaration of Helsinki. Informed consent will be obtained from all parents prior to the evaluations after careful explanations to each patient.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Obesity, Childhood
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mediterranean Style-Diet Group
These subjects will receive a standard diet according to routine clinical practice + a 30 minutes Mediterranean-Style Diet educational training with explanation of Mediterranean pyramid + gamification to Mediterranean diet inside the Hospital and at home throughout "The Mediterranean Goose".
Group Type
EXPERIMENTAL
Mediterranean-Style Diet Educational Training
Intervention Type
BEHAVIORAL
The intervention consists in a standard diet according to routine clinical practice + a 30 minutes Mediterranean-Style Diet educational training with explanation of Mediterranean pyramid + gamification to Mediterranean diet inside the Hospital and at home throughout "The Mediterranean Goose".
Standard Diet Group
These subjects will receive Standard Diet according to routine care and practice. The standard diet will be distributed with 55-60% of carbohydrates (45-50% complex and no more than 10% refined and processed sugars), 25-30% lipids and 15% proteins, and will be performedin accordance with the calories of an isocaloric balanced diet calculated throughout the Italian LARN Guidelines for age and gender (Società Italiana di Nutrizione Umana, 2014), inspired to Mediterranean pyramid.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mediterranean-Style Diet Educational Training
The intervention consists in a standard diet according to routine clinical practice + a 30 minutes Mediterranean-Style Diet educational training with explanation of Mediterranean pyramid + gamification to Mediterranean diet inside the Hospital and at home throughout "The Mediterranean Goose".
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* obesity, according to the IOTF criteria;
* waist circumference ≥ 90th percentile;
* diet naïve or with failure of weight loss (defined as -1 kg/m2 BMI in 1 year).
* waist circumference ≥ 90th percentile;
* diet naïve or with failure of weight loss (defined as -1 kg/m2 BMI in 1 year).
Exclusion Criteria
* specific causes of endocrine or genetic obesity;
* type 1 diabetes;
* previous kidney diseases.
* type 1 diabetes;
* previous kidney diseases.
Minimum Eligible Age
10 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Azienda Ospedaliero Universitaria Maggiore della Carita
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Flavia Prodam
Assoc. Professor in Clinical Nutrition
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont
Novara, , Italy
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Italy
References
Explore related publications, articles, or registry entries linked to this study.
Cole TJ, Lobstein T. Extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity. Pediatr Obes. 2012 Aug;7(4):284-94. doi: 10.1111/j.2047-6310.2012.00064.x. Epub 2012 Jun 19.
Reference Type
BACKGROUND
Cook S, Weitzman M, Auinger P, Nguyen M, Dietz WH. Prevalence of a metabolic syndrome phenotype in adolescents: findings from the third National Health and Nutrition Examination Survey, 1988-1994. Arch Pediatr Adolesc Med. 2003 Aug;157(8):821-7. doi: 10.1001/archpedi.157.8.821.
Reference Type
BACKGROUND
Cruz ML, Goran MI. The metabolic syndrome in children and adolescents. Curr Diab Rep. 2004 Feb;4(1):53-62. doi: 10.1007/s11892-004-0012-x.
Reference Type
BACKGROUND
de Ferranti SD, Gauvreau K, Ludwig DS, Neufeld EJ, Newburger JW, Rifai N. Prevalence of the metabolic syndrome in American adolescents: findings from the Third National Health and Nutrition Examination Survey. Circulation. 2004 Oct 19;110(16):2494-7. doi: 10.1161/01.CIR.0000145117.40114.C7. Epub 2004 Oct 11.
Reference Type
BACKGROUND
Società Italiana di Nutrizione Umana.(2014).Livelli di assunzione raccomandati di energia e nutrienti per la popolazione italiana (LARN). Milan, Italy: S.I.N.U.
Reference Type
BACKGROUND
Bach-Faig A, Berry EM, Lairon D, Reguant J, Trichopoulou A, Dernini S, Medina FX, Battino M, Belahsen R, Miranda G, Serra-Majem L; Mediterranean Diet Foundation Expert Group. Mediterranean diet pyramid today. Science and cultural updates. Public Health Nutr. 2011 Dec;14(12A):2274-84. doi: 10.1017/S1368980011002515.
Reference Type
BACKGROUND
Tanner JM. (1961). Growth at adolescence. 2 edn. Oxford: Blackwell Scientific Publications
Reference Type
BACKGROUND
Hogg RJ, Furth S, Lemley KV, Portman R, Schwartz GJ, Coresh J, Balk E, Lau J, Levin A, Kausz AT, Eknoyan G, Levey AS; National Kidney Foundation's Kidney Disease Outcomes Quality Initiative. National Kidney Foundation's Kidney Disease Outcomes Quality Initiative clinical practice guidelines for chronic kidney disease in children and adolescents: evaluation, classification, and stratification. Pediatrics. 2003 Jun;111(6 Pt 1):1416-21. doi: 10.1542/peds.111.6.1416.
Reference Type
BACKGROUND
Schwartz GJ, Munoz A, Schneider MF, Mak RH, Kaskel F, Warady BA, Furth SL. New equations to estimate GFR in children with CKD. J Am Soc Nephrol. 2009 Mar;20(3):629-37. doi: 10.1681/ASN.2008030287. Epub 2009 Jan 21.
Reference Type
BACKGROUND
Kahn SE, Prigeon RL, McCulloch DK, Boyko EJ, Bergman RN, Schwartz MW, Neifing JL, Ward WK, Beard JC, Palmer JP, et al. Quantification of the relationship between insulin sensitivity and beta-cell function in human subjects. Evidence for a hyperbolic function. Diabetes. 1993 Nov;42(11):1663-72. doi: 10.2337/diab.42.11.1663.
Reference Type
BACKGROUND
Serra-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.
Reference Type
BACKGROUND
Istituto Superiore della Sanità, Censi L, D'Addesa D, Galeone D et al. (2012). Studio ZOOM8: l'alimentazione e l'attività fisica dei bambini della scuola primaria. Rapporti ISTISAN 12/42.
Reference Type
BACKGROUND
Huybrechts I, Bornhorst C, Pala V, Moreno LA, Barba G, Lissner L, Fraterman A, Veidebaum T, Hebestreit A, Sieri S, Ottevaere C, Tornaritis M, Molnar D, Ahrens W, De Henauw S; IDEFICS Consortium. Evaluation of the Children's Eating Habits Questionnaire used in the IDEFICS study by relating urinary calcium and potassium to milk consumption frequencies among European children. Int J Obes (Lond). 2011 Apr;35 Suppl 1:S69-78. doi: 10.1038/ijo.2011.37.
Reference Type
BACKGROUND
Cavicchia PP, Steck SE, Hurley TG, Hussey JR, Ma Y, Ockene IS, Hebert JR. A new dietary inflammatory index predicts interval changes in serum high-sensitivity C-reactive protein. J Nutr. 2009 Dec;139(12):2365-72. doi: 10.3945/jn.109.114025. Epub 2009 Oct 28.
Reference Type
BACKGROUND
Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14.
Reference Type
BACKGROUND
Alberti-Fidanza A, Fidanza F. Mediterranean Adequacy Index of Italian diets. Public Health Nutr. 2004 Oct;7(7):937-41. doi: 10.1079/phn2004557.
Reference Type
BACKGROUND
Hagstromer 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.
Reference Type
BACKGROUND
Mannocci A, Masala D, Mei D, Tribuzio AM, Villari P, LA Torre G. International Physical Activity Questionnaire for Adolescents (IPAQ A): reliability of an Italian version. Minerva Pediatr (Torino). 2021 Oct;73(5):383-390. doi: 10.23736/S2724-5276.16.04727-7. Epub 2018 Jan 29.
Reference Type
BACKGROUND
Prodam F, Ricotti R, Agarla V, Parlamento S, Genoni G, Balossini C, Walker GE, Aimaretti G, Bona G, Bellone S. High-end normal adrenocorticotropic hormone and cortisol levels are associated with specific cardiovascular risk factors in pediatric obesity: a cross-sectional study. BMC Med. 2013 Feb 20;11:44. doi: 10.1186/1741-7015-11-44.
Reference Type
BACKGROUND
Prodam F, Savastio S, Genoni G, Babu D, Giordano M, Ricotti R, Aimaretti G, Bona G, Bellone S. Effects of growth hormone (GH) therapy withdrawal on glucose metabolism in not confirmed GH deficient adolescents at final height. PLoS One. 2014 Jan 30;9(1):e87157. doi: 10.1371/journal.pone.0087157. eCollection 2014.
Reference Type
BACKGROUND
Prodam F, Zanetta S, Ricotti R, Marolda A, Giglione E, Monzani A, Walker GE, Rampone S, Castagno M, Bellone S, Petri A, Aimaretti G, Bona G. Influence of Ultraviolet Radiation on the Association between 25-Hydroxy Vitamin D Levels and Cardiovascular Risk Factors in Obesity. J Pediatr. 2016 Apr;171:83-9.e1. doi: 10.1016/j.jpeds.2015.12.032. Epub 2016 Jan 12.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.med-diet.eu
"Mediterranean diet and enhancement of traditional foodstuff - MedDiet"
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CE 50/17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Overweight and Obesity in Preschoolers
NCT03800823
ACTIVE_NOT_RECRUITING
NA
Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity
NCT04422951
TERMINATED
NA
Evaluation of Long-term Digital Childhood Obesity Treatment
NCT06434259
COMPLETED
Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care
NCT01822626
COMPLETED
NA
Childhood Obesity Treatment - Telephone Coaching vc Usual Care
NCT02794090
COMPLETED
NA
Effectiveness of a Mobile Health Intervention for the Prevention of Overweight and Obesity in Adolescents
NCT05329753
COMPLETED
NA
Complementary Weaning With Adult Food Typical of the Mediterranean Diet
NCT05297357
COMPLETED
NA
Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children
NCT07184281
RECRUITING
NA
Childhood Obesity- Characteristics and Treatment
NCT00961740
COMPLETED
NA
MEditerranean LIfestyle in Pediatric Obesity Prevention
NCT04597281
RECRUITING
NA
Lifestyle Modification Intervention for Obese Children
NCT03429699
COMPLETED
NA
Hyvinkää Childhood Obesity Study (HCOS), Randomized Controlled Clinical Trial for Effectiveness and Costs of a 1-year Lifestyle Intervention.
NCT06126679
ACTIVE_NOT_RECRUITING
NA
The System Fammeal With Tailored Recommendations and Gamification for Parents to Counteract Childhood Obesity
NCT03881280
COMPLETED
NA
Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention
NCT01757925
COMPLETED
PHASE4
Pediatric Obesity Observational Prospective Trial
NCT03139877
COMPLETED
The More & Less Study: A Trial Testing Different Treatment Approaches to Obesity in Preschoolers
NCT01792531
COMPLETED
NA
Computerised Decision-Support Tool for Childhood Obesity Management
NCT03819673
COMPLETED
NA
Childhood Overweight
NCT00916318
UNKNOWN
NA
Fixed Diet Plan and Calorie Counting Diet in Adolescents
NCT02741908
COMPLETED
NA
A web-and Mobile Phone-based Intervention in 4-year-olds: a Population-based Randomized Controlled Trial
NCT02021786
COMPLETED
NA
Childhood Obesity Treatment: A Maintenance Approach
NCT00759746
COMPLETED
NA
Factors Associated With Changes in Weight-status in Danish School Children With Obesity
NCT06077266
COMPLETED
Pain and Weight Treatment: Development and Trial of PAW
NCT04046562
RECRUITING
NA
Acceptance-based Care for Child Eating and Physical Activity Treatment
NCT03368716
COMPLETED
NA
Motivation Approach for Childhood Obesity Treatment
NCT02889406
UNKNOWN
NA