Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity

NCT06312280 | Not Yet Recruiting

• 1 other identifier: CE342/2023
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pediatric Obesity

Keywords

pediatric; obesity; overweight; body composition

Outcome Measures

Primary Outcomes (1)

• Change in Body composition

  evaluation of body composition with Bioimpendence analysis (BIA)

  Change of body composition at baseline (V0) and after 3 months (V3) and 6 months (V6)

Secondary Outcomes (2)

• Dietary compliance with questionnaires

  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)

  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)

Study Arms (1)

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)

Behavioral: Mediterranean diet

Interventions

Mediterranean diet BEHAVIORAL

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.

Pediatric children and adolescents with obesity or overweight

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

6-17 years pediatric subjects with obesity or overweight

You may qualify if:

• Age between 6 and 17 years;
• BMI compatible with obesity or overweight according to IOTF criteria
• Signature of informed consent by parents/legal tutors.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

SCDU Pediatria, AOU Maggiore della Carità

Novara, 28100, Italy

Location

Related Publications (8)

• 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.

  PMID: 26528631 BACKGROUND

• Tremmel 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.

  PMID: 28422077 BACKGROUND

• Valerio 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.

  PMID: 30064525 BACKGROUND

• Khalil 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.

  PMID: 24949644 BACKGROUND

• Cacciari 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.

  PMID: 16957405 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.

  PMID: 15482620 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.

  PMID: 19011653 BACKGROUND

• Chen 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.

  PMID: 35094911 BACKGROUND

Related Links

• Okkio alla salute Data

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Overweight

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Simonetta Bellone, MD

  AOU Maggiore della Carità

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simonetta Bellone, MD

CONTACT

+39-0321-660693; simonetta.bellone@med.uniupo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 15, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: November 30, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)