Prevention of Obesity in Toddlers (PROBIT) Trial.

NCT03131284 | Completed

• 1 other identifier: 368 CEP
• Study Type: interventional
• Target: 569
• Locations: 1 country
• Sites: 1

Brief Summary

AIM: to reduce the prevalence of overweight and obesity at two years of age in the intervention group compared to the control group. METHODS: Eleven primary paediatricians were randomized to the intervention group and intensively trained about the trial intervention. Each of them was asked to consecutively recruit the parents of at least 30 newborns taken in charge within the first six months of the study, and to provide them with standardized oral and written information on protective practices during all the well visits scheduled in the first two years of the child's life. Another eleven primary paediatricians were randomized to the control group, and were asked to consecutively recruit the parents of at least 30 newborns taken in charge within the first six months of the study and to provide them with usual care and follow-up. When all recruited children have completed the second year of life, the two groups of toddlers will be compared as regards the prevalence of overweight/obesity, defined by WHO cut-offs of the weight/length ratio.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• Body mass index (BMI) at two years of age.

  Overweight = BMI above 85° percentile of the CDC curves; Obesity = BMI above 95° percentile of the CDC curves.

  Third year of the study.

Secondary Outcomes (2)

• Weight/length ratio at one year of age.

  Second year of the study.

• Beverages at two years of age.

  Third year of the study.

Study Arms (2)

Control

NO INTERVENTION

Families of newborns whose paediatrician is assigned to the control arm, receive usual education about nutrition and lifestyle, during their child's first two years of life.

Intensive education.

EXPERIMENTAL

Families of newborns whose paediatrician is assigned to the intervention arm, receive standardized lifestyle counseling along with educational written material about their child's first two years of life, which corresponds to the experimental treatment.

Behavioral: Intensive education

Interventions

Intensive education BEHAVIORAL

For each well visit within the first two years of their child's life, parents are provided with oral and written information on behaviors to adopt for their child to be protected from obesity: breast feeding, feeding on demand, responsive feeding, correct time of introduction of complementary feeding, portions shaped on the child's appetite, avoiding "pressing the child to eat more" and rewarding or punishing the child with food, avoiding added sugar and beverages other than milk and water, practicing active game with the child, alternating protein sources correctly and avoiding protein excess. Written menus examples and coloured photos of average portions are given for complementary feeding. Parents are also provided with information about health consequences of childhood obesity.

Intensive education.

Eligibility Criteria

• Age: 5 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age: 37-42 weeks; no perinatal complication; informed consent from parents.

You may not qualify if:

• Any congenital disorder, disease or syndrome.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Pediatric Diabetes and Metabolic Disorders Unit, Department of Life and Reproduction Sciences, University of Verona, 1 Piazzale Stefani

Verona, 37126, Italy

Location

Related Publications (10)

• Pigeot I, Barba G, Chadjigeorgiou C, de Henauw S, Kourides Y, Lissner L, Marild S, Pohlabeln H, Russo P, Tornaritis M, Veidebaum T, Wawro N, Siani A. Prevalence and determinants of childhood overweight and obesity in European countries: pooled analysis of the existing surveys within the IDEFICS Consortium. Int J Obes (Lond). 2009 Oct;33(10):1103-10. doi: 10.1038/ijo.2009.142. Epub 2009 Jul 28.

  PMID: 19636314 BACKGROUND

• Reilly JJ, Kelly J. Long-term impact of overweight and obesity in childhood and adolescence on morbidity and premature mortality in adulthood: systematic review. Int J Obes (Lond). 2011 Jul;35(7):891-8. doi: 10.1038/ijo.2010.222. Epub 2010 Oct 26.

  PMID: 20975725 BACKGROUND

• Binkin N, Fontana G, Lamberti A, Cattaneo C, Baglio G, Perra A, Spinelli A. A national survey of the prevalence of childhood overweight and obesity in Italy. Obes Rev. 2010 Jan;11(1):2-10. doi: 10.1111/j.1467-789X.2009.00650.x. Epub 2009 Sep 17.

  PMID: 19761508 BACKGROUND

• Oude Luttikhuis H, Baur L, Jansen H, Shrewsbury VA, O'Malley C, Stolk RP, Summerbell CD. Interventions for treating obesity in children. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001872. doi: 10.1002/14651858.CD001872.pub2.

  PMID: 19160202 BACKGROUND

• Waters E, de Silva-Sanigorski A, Hall BJ, Brown T, Campbell KJ, Gao Y, Armstrong R, Prosser L, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD001871. doi: 10.1002/14651858.CD001871.pub3.

  PMID: 22161367 BACKGROUND

• Stocks T, Renders CM, Bulk-Bunschoten AM, Hirasing RA, van Buuren S, Seidell JC. Body size and growth in 0- to 4-year-old children and the relation to body size in primary school age. Obes Rev. 2011 Aug;12(8):637-52. doi: 10.1111/j.1467-789X.2011.00869.x. Epub 2011 Mar 23.

  PMID: 21426479 BACKGROUND

• Wojcicki JM, Heyman MB. Let's Move--childhood obesity prevention from pregnancy and infancy onward. N Engl J Med. 2010 Apr 22;362(16):1457-9. doi: 10.1056/NEJMp1001857. Epub 2010 Apr 14. No abstract available.

  PMID: 20393165 BACKGROUND

• Daniels LA, Mallan KM, Battistutta D, Nicholson JM, Perry R, Magarey A. Evaluation of an intervention to promote protective infant feeding practices to prevent childhood obesity: outcomes of the NOURISH RCT at 14 months of age and 6 months post the first of two intervention modules. Int J Obes (Lond). 2012 Oct;36(10):1292-8. doi: 10.1038/ijo.2012.96. Epub 2012 Jun 19.

  PMID: 22710926 BACKGROUND

• WHO Multicentre Growth Reference Study Group. WHO Child Growth Standards based on length/height, weight and age. Acta Paediatr Suppl. 2006 Apr;450:76-85. doi: 10.1111/j.1651-2227.2006.tb02378.x.

  PMID: 16817681 BACKGROUND

• Morandi A, Tommasi M, Soffiati F, Destro F, Fontana L, Grando F, Simonetti G, Bucolo C, Alberti E, Baraldi L, Chiriaco A, Ferrarese N, Frignani G, Pasqualini M, Rossi V, Siciliano C, Zuccolo AM, Matticchio G, Vettori V, Danieli D, Guarda L, Iuliano M, Raimo F, Sirpresi S, Trevisan E, Vinco S, Maffeis C. Prevention of obesity in toddlers (PROBIT): a randomised clinical trial of responsive feeding promotion from birth to 24 months. Int J Obes (Lond). 2019 Oct;43(10):1961-1966. doi: 10.1038/s41366-019-0406-0. Epub 2019 Jul 3.

  PMID: 31270429 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: July 1, 2014
• Primary Completion: December 15, 2016
• Study Completion: June 30, 2017
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)