Completed

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

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What is being tested

motivational counseling

Behavioral
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 4 to 7 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: June 2011
See protocol details

Summary

Principal SponsorAzienda USL Reggio Emilia - IRCCS
Last updated: April 4, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01822626
Principal SponsorAzienda USL Reggio Emilia - IRCCS
Last updated: April 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

372 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 7 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionObesityOverweight

Criteria

4 inclusion criteria required to participate
4-7 years old
assisted by the pediatrician at least for 12 months
overweight children with BMI percentile between 85° and 94°
resident in Reggio Emilia Province
2 exclusion criteria prevent from participating
family in pre-contemplation stage
metabolic pathologies and all pathologies related with obesity

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

No Intervention

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Local Health Authority of Reggio Emilia

Reggio Emilia, ItalyOpen Local Health Authority of Reggio Emilia in Google Maps
CompletedOne Study Center