Clinical trial NCT03819673: Computerised Decision-Support Tool for Childhood Obesity Management
Official title: A Computerised Decision-Support Tool for Health Professionals for the Prevention and Treatment of Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Personalised
Nutrition
Intervention
Children
Obesity
Health professionals
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 65
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kallithea
country: Greece
facility: Harokopio University of Athens
state: Attica
Study officials:
affiliation: Harokopio University, Athens, Greece
name: Yannis Manios, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: La Trobe University, Bundoora, VIC 3086, Australia
name: George Moschonis, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: