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

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Behavioral: motivational counseling

• Registration Number: NCT01822626
• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-03-28
• Status Verified: 2013-04
• Study First Posted: 2013-04-02
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
motivational counseling	motivational counseling	-

Primary Outcome Measures

Name	Time	Method
BMI variation from baseline	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 Outcome Measures

Name	Time	Method
Physical Activity behaviors variations	12 months	Physical activity: variation from baseline and 12-month questionnaire in weekly frequency of organized and spontaneous physical activity, variation from baseline and 12-month questionnaire in daily hours of television and computer.
Diatary behaviors variations	12 month	Dietary behaviors: variation from baseline and 12-month questionnaire of consumption of foods and drinks.

Trial Locations

Locations (1)

Local Health Authority of Reggio Emilia; 🇮🇹 Reggio Emilia, Italy