search
Back to results

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
Harokopio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Personalised, Nutrition, Intervention, Children, Obesity, Health professionals

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

First Posted
January 25, 2019
Last Updated
January 30, 2019
Sponsor
Harokopio University
search

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