An interventional study of motivational counseling in Overweight, sponsored by Azienda Unità Sanitaria Locale Reggio Emilia. Completed at 1 site in Italy. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2013-04-04.
Sponsored by Azienda Unità Sanitaria Locale Reggio Emilia · Not applicable, Interventional, and Prevention
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.
3,671 studies on the registry are indexed under Overweight; 850 are open to participants now.
This study's enrollment of 372 is above the median of 74 across 3,176 interventional studies indexed under Overweight.
Browse Overweight studies →Azienda Unità Sanitaria Locale Reggio Emilia is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Azienda Unità Sanitaria Locale Reggio Emilia