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Clinical Trials/NCT01822626
NCT01822626
Completed
Not Applicable

Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care

Azienda Unità Sanitaria Locale Reggio Emilia1 site in 1 country372 target enrollmentJune 2011
ConditionsOverweight

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight
Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia
Enrollment
372
Locations
1
Primary Endpoint
BMI variation from baseline
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Obesity is one of the leading causes of morbidity and mortality in the industrialised world. Evidence is growing that early life nutrition can play a role in behavioural and cognitive problems in children and adolescents and is well documented that being overweight and obese during childhood can have short- and long-term physical and psycho-social health implications.

This is an individually randomised trial to evaluate the efficacy of a family pediatrician-lead counselling intervention in reducing the BMI of over-weight children aged 4-7 years old. As secondary objectives the investigators evaluate the effect of the counselling on dietary behaviours and physical activity.

The investigators targeted the intervention to overweight children, while obese children were referred to specialised care. The counselling targeted diet, physical activity, and sedentary behaviours.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
August 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • overweight children with BMI percentile between 85° and 94°
  • 4-7 years old
  • resident in Reggio Emilia Province
  • assisted by the pediatrician at least for 12 months

Exclusion Criteria

  • metabolic pathologies and all pathologies related with obesity
  • family in pre-contemplation stage

Outcomes

Primary Outcomes

BMI variation from baseline

Time Frame: 12 months

Difference between 12-month BMI score (weight/heigh2) and time-0 BMI score. Intervention average and control average BMI score are compared by Wilcoxon-Mann Whitney Test.

Secondary Outcomes

  • Physical Activity behaviors variations(12 months)
  • Diatary behaviors variations(12 month)

Study Sites (1)

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