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Clinical Trials/NCT03819673
NCT03819673
Completed
Not Applicable

A Computerised Decision-Support Tool for Health Professionals for the Prevention and Treatment of Childhood Obesity

Harokopio University1 site in 1 country65 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Obesity
Sponsor
Harokopio University
Enrollment
65
Locations
1
Primary Endpoint
Body Mass Index (BMI)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The objective of the present study was to examine the effectiveness of a computerised decision-support tool, developed to assist paediatric clinicians in delivering personalised nutrition and lifestyle optimization advice to children and their families, as a means of childhood obesity management.

Detailed Description

The objective of the present study was to examine the effectiveness of a computerised decision-support tool, developed to assist paediatric clinicians in delivering personalised nutrition and lifestyle optimization advice to children and their families, as a means of childhood obesity management. The effectiveness of the decision support tool was assessed through a pilot randomized controlled intervention trial (RCT). The RCT was initiated on May 2018 and was conducted in the Endocrinology Department of the "P. A. Kyriakou" Children's Hospital and in the Division of Endocrinology, Metabolism, and Diabetes of the "Aghia Sophia" Children's Hospital in Athens, Greece. Sixty-five overweight or obese children that were eligible to participate in the RCT, were randomly and equally allocated to two study groups. Those children that were randomly allocated to the intervention group (IG), were examined by health professionals (i.e. paediatricians, paediatric endocrinologists and a dietitian) who were trained in the use of the decision support tool. The latter assisted the medical professionals to assess children's weight status, to set appropriate weight management goals and provide personalised meal plans and/or recommendations to children and their families. On the contrary, those children that were randomly allocated to the control group (CG) received the usual care advice that is routinely provided to children in the two hospitals and includes child visits and follow-up appointments for weight checks with their primary care provider or dietitian. The effectiveness of the intervention was evaluated through the collection of data at baseline and at a follow-up examination after 3 months. All data were uploaded to the decision-support tool, which analysed them and extracted a report with the child's assessment, as well as with personalised diet and lifestyle optimization recommendations. More specifically, the decision support tool proposed personalised weekly meal plans adjusted to the estimated energy requirements calculated for each child, as well as personalised diet and lifestyle optimization advice recommendations for the child and/or the entire family. Lastly, the decision support tool suggested a periodic re-evaluation every 3 or 6 months depending on the child's current weight status, the presence of obesity-related comorbidity in children and the presence of obesity in at least one or both parents.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
October 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yannis Manios

Principal Investigator

Harokopio University

Eligibility Criteria

Inclusion Criteria

  • Children aged 6-12 years old
  • Overweight status or obesity (i.e. BMI-for-age \> 85th percentile)

Exclusion Criteria

  • Age range not within the inclusion criteria

Outcomes

Primary Outcomes

Body Mass Index (BMI)

Time Frame: 3-6 months

Study Sites (1)

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