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Prevention of Obesity in Toddlers (PROBIT) Trial.

NCT03131284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 569

Last updated 2018-06-26

No results posted yet for this study

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

Interventions

BEHAVIORAL

Intensive education

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.

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-01
Primary Completion
2016-12-15
Completion
2017-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131284 on ClinicalTrials.gov