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

Azienda USL Reggio Emilia - IRCCS372 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

372

Conditions

Overweight

Interventions

A family pediatrician-lead counselling was offered to children assigned to the intervention group. The counselling program consisted of 5 motivational interviews based on Stages of Change Theory. Child and family always had to leave the meeting having agreed two objectives, one concerning food and one physical activity improvements, clearly defined and achievable. During each subsequent interview was assessed the degree of achievement of the objectives of the previous meeting. Based on the assessment the objective could be reinforced or redefined. After each change the objectives were recorded.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 7 Years

Medical Language ↔ Plain English

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

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.

Time frame: 12 months

Secondary Outcomes

Physical Activity behaviors variations

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.

Time frame: 12 months

Diatary behaviors variations

Dietary behaviors: variation from baseline and 12-month questionnaire of consumption of foods and drinks.

Time frame: 12 month