Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01822626
Enrollment
372
Registered
2013-04-02
Start date
2011-06-30
Completion date
2012-08-31
Last updated
2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

overweight, obesity, children, BMI, counseling, pediatrician

Brief 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.

Interventions

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.

Sponsors

Azienda USL Reggio Emilia - IRCCS
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BMI variation from baseline12 monthsDifference 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.

Secondary

MeasureTime frameDescription
Physical Activity behaviors variations12 monthsPhysical 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 variations12 monthDietary behaviors: variation from baseline and 12-month questionnaire of consumption of foods and drinks.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026