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

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ClinicalTrials.gov Identifier: NCT01822626
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Azienda Unità Sanitaria Locale Reggio Emilia

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.


Condition or disease Intervention/treatment Phase
Overweight Behavioral: motivational counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care
Study Start Date : June 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: motivational counseling Behavioral: motivational counseling
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.

No Intervention: Usual Care



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Physical Activity behaviors variations [ Time Frame: 12 months ]
    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.

  2. Diatary behaviors variations [ Time Frame: 12 month ]
    Dietary behaviors: variation from baseline and 12-month questionnaire of consumption of foods and drinks.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822626


Locations
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Italy
Local Health Authority of Reggio Emilia
Reggio Emilia, Italy, 42122
Sponsors and Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia
Investigators
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Principal Investigator: Anna Maria Davoli Primary Care Program, Local Health Authority of Reggio Emilia, Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier: NCT01822626    
Other Study ID Numbers: reggioemilia2013
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013
Keywords provided by Azienda Unità Sanitaria Locale Reggio Emilia:
overweight
obesity
children
BMI
counseling
pediatrician
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms