Computerised Decision-Support Tool for Childhood Obesity Management
NCT ID: NCT03819673
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2018-05-01
2018-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group (IG)
Care based on the computerised decision-support tool
Intervention Group Care
children's assessment, setting weight management goals, provision of personalised meal plans, personalised diet and lifestyle optimization advice recommendations to children and their families, periodic re-evaluation every 3 or 6 months
Control Group (CG)
Usual care advice by primary care provider or dietitian of participating hospital
No interventions assigned to this group
Interventions
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Intervention Group Care
children's assessment, setting weight management goals, provision of personalised meal plans, personalised diet and lifestyle optimization advice recommendations to children and their families, periodic re-evaluation every 3 or 6 months
Eligibility Criteria
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Inclusion Criteria
* Overweight status or obesity (i.e. BMI-for-age \> 85th percentile)
6 Years
12 Years
ALL
Yes
Sponsors
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Harokopio University
OTHER
Responsible Party
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Yannis Manios
Principal Investigator
Principal Investigators
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Yannis Manios, Professor
Role: PRINCIPAL_INVESTIGATOR
Harokopio University, Athens, Greece
George Moschonis, Associate Professor
Role: PRINCIPAL_INVESTIGATOR
La Trobe University, Bundoora, VIC 3086, Australia
Locations
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Harokopio University of Athens
Kallithea, Attica, Greece
Countries
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Other Identifiers
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e-tool for childhood obesity
Identifier Type: -
Identifier Source: org_study_id
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