Computerised Decision-Support Tool for Childhood Obesity Management
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Intervention Group Care
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Personalised, Nutrition, Intervention, Children, Obesity, Health professionals
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
Sites / Locations
- Harokopio University of Athens
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group (IG)
Control Group (CG)
Arm Description
Care based on the computerised decision-support tool
Usual care advice by primary care provider or dietitian of participating hospital
Outcomes
Primary Outcome Measures
Body Mass Index (BMI)
Secondary Outcome Measures
Full Information
NCT ID
NCT03819673
First Posted
January 25, 2019
Last Updated
January 30, 2019
Sponsor
Harokopio University
1. Study Identification
Unique Protocol Identification Number
NCT03819673
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Personalised, Nutrition, Intervention, Children, Obesity, Health professionals
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group (IG)
Arm Type
Experimental
Arm Description
Care based on the computerised decision-support tool
Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
Usual care advice by primary care provider or dietitian of participating hospital
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannis Manios, Professor
Organizational Affiliation
Harokopio University, Athens, Greece
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Moschonis, Associate Professor
Organizational Affiliation
La Trobe University, Bundoora, VIC 3086, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harokopio University of Athens
City
Kallithea
State/Province
Attica
ZIP/Postal Code
17671
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Computerised Decision-Support Tool for Childhood Obesity Management
We'll reach out to this number within 24 hrs