GOOD-DAY Trial in Paediatric Obesity

NCT03154255 | Completed DMC

• 1 other identifier: CE 50/17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Childhood

Keywords

Obesity; Paediatric; Mediterranean diet; Gamification; Insulin-resistance

Outcome Measures

Primary Outcomes (1)

• Change in weight - weight loss

  Variation of body mass index (BMI)

  Change from Baseline BMI at 3 months, 6 months and 12 months

Secondary Outcomes (4)

• Metabolic control

  Change from Baseline HOMA-IR at 3 months, 6 months and 12 months

• Metabolic control

  Change from Baseline lipid profile at 3 months, 6 months and 12 months

• Metabolic control

  Change from Baseline blood pressure at 3 months, 6 months and 12 months

• Adherence to Mediterranean Diet

  Change from Baseline KIDMED Index at 3 months, 6 months and 12 months

Study Arms (2)

Mediterranean Style-Diet Group

EXPERIMENTAL

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".

Behavioral: Mediterranean-Style Diet Educational Training

Standard Diet Group

NO INTERVENTION

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.

Interventions

Mediterranean-Style Diet Educational Training 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".

Mediterranean Style-Diet Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• specific causes of endocrine or genetic obesity;
• type 1 diabetes;
• previous kidney diseases.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont

Novara, 28100, Italy

Location

Related Publications (21)

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  PMID: 22715120 BACKGROUND

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• 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.

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• 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.

  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.

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• Tanner JM. (1961). Growth at adolescence. 2 edn. Oxford: Blackwell Scientific Publications

  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.

  PMID: 12777562 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.

  PMID: 19158356 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.

  PMID: 8405710 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

• 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.

  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.

  PMID: 21483425 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.

  PMID: 19864399 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.

  PMID: 23941862 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.

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• 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

• 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.

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• 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.

  PMID: 23425018 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.

  PMID: 24498035 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.

  PMID: 26794470 BACKGROUND

Related Links

• "Mediterranean diet and enhancement of traditional foodstuff - MedDiet"

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor in Clinical Nutrition

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 16, 2017
• Study Start: October 3, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2022
• Last Updated: July 24, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)