NCT01822626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.2 years

First QC Date

March 28, 2013

Last Update Submit

April 2, 2013

Conditions

Overweight

Keywords

overweightobesitychildrenBMIcounselingpediatrician

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Physical Activity behaviors variations

    12 months

  • Diatary behaviors variations

    12 month

Study Arms (2)

motivational counseling

EXPERIMENTAL
Behavioral: motivational counseling

Usual Care

NO INTERVENTION

Interventions

motivational counselingBEHAVIORAL

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.

motivational counseling

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • overweight children with BMI percentile between 85° and 94°
  • years old
  • resident in Reggio Emilia Province
  • assisted by the pediatrician at least for 12 months

You may not qualify if:

  • metabolic pathologies and all pathologies related with obesity
  • family in pre-contemplation stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Health Authority of Reggio Emilia

Reggio Emilia, Italy, 42122, Italy

Location

Related Publications (1)

  • Davoli AM, Broccoli S, Bonvicini L, Fabbri A, Ferrari E, D'Angelo S, Di Buono A, Montagna G, Panza C, Pinotti M, Romani G, Storani S, Tamelli M, Candela S, Giorgi Rossi P. Pediatrician-led motivational interviewing to treat overweight children: an RCT. Pediatrics. 2013 Nov;132(5):e1236-46. doi: 10.1542/peds.2013-1738. Epub 2013 Oct 21.

    PMID: 24144717DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Maria Davoli

    Primary Care Program, Local Health Authority of Reggio Emilia, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 2, 2013

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

IT(1)