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

Azienda Unità Sanitaria Locale Reggio Emilia

Status: Completed

Conditions: Overweight

Treatments: Behavioral: motivational counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01822626

reggioemilia2013

Details and patient eligibility

About

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.

Enrollment: 372 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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372 participants in 2 patient groups

motivational counseling

Experimental group

Treatment:

Behavioral: motivational counseling

Usual Care

No Intervention group