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

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
motivational counseling
Sponsored by
Azienda Unità Sanitaria Locale Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring overweight, obesity, children, BMI, counseling, pediatrician

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Local Health Authority of Reggio Emilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

motivational counseling

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Physical Activity behaviors variations
Physical 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 variations
Dietary behaviors: variation from baseline and 12-month questionnaire of consumption of foods and drinks.

Full Information

First Posted
March 28, 2013
Last Updated
April 2, 2013
Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia
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1. Study Identification

Unique Protocol Identification Number
NCT01822626
Brief Title
Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care
Official Title
Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
overweight, obesity, children, BMI, counseling, pediatrician

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
motivational counseling
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
motivational counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI variation from baseline
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Physical Activity behaviors variations
Description
Physical 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.
Time Frame
12 months
Title
Diatary behaviors variations
Description
Dietary behaviors: variation from baseline and 12-month questionnaire of consumption of foods and drinks.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Maria Davoli
Organizational Affiliation
Primary Care Program, Local Health Authority of Reggio Emilia, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local Health Authority of Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42122
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24144717
Citation
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.
Results Reference
derived

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

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