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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822626
• Other study ID #: reggioemilia2013
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: April 2, 2013
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: none
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight

Intervention

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.

Locations

Country	Name	City	State
Italy	Local Health Authority of Reggio Emilia	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Diatary behaviors variations	Dietary behaviors: variation from baseline and 12-month questionnaire of consumption of foods and drinks.	12 month	No