Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care
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|ClinicalTrials.gov Identifier: NCT01822626|
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : April 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Overweight||Behavioral: motivational counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||372 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
|Experimental: motivational counseling||
Behavioral: motivational counseling
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.
|No Intervention: Usual Care|
- 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.
- Physical Activity behaviors variations [ Time Frame: 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 [ Time Frame: 12 month ]Dietary behaviors: variation from baseline and 12-month questionnaire of consumption of foods and drinks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822626
|Local Health Authority of Reggio Emilia|
|Reggio Emilia, Italy, 42122|
|Principal Investigator:||Anna Maria Davoli||Primary Care Program, Local Health Authority of Reggio Emilia, Italy|