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

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight

Intervention / Treatment
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* Behavioral: motivational counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: motivational counseling<br> | Behavioral: motivational counseling<br>* 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.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| Diatary behaviors variations | Dietary behaviors: variation from baseline and 12-month questionnaire of consumption of foods and drinks. | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obesity, children, BMI, counseling, pediatrician