Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 372
- Locations
- 2
- Primary Endpoint
- BMI variation from baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 7 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Physical Activity behaviors variations(12 months)
- Diatary behaviors variations(12 month)