NCT03819673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

January 25, 2019

Last Update Submit

January 30, 2019

Conditions

Childhood Obesity

Keywords

PersonalisedNutritionInterventionChildrenObesityHealth professionals

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (BMI)

    3-6 months

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

Care based on the computerised decision-support tool

Behavioral: Intervention Group Care

Control Group (CG)

NO INTERVENTION

Usual care advice by primary care provider or dietitian of participating hospital

Interventions

Intervention Group CareBEHAVIORAL

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

Intervention Group (IG)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harokopio University of Athens

Kallithea, Attica, 17671, Greece

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yannis Manios, Professor

    Harokopio University, Athens, Greece

    PRINCIPAL INVESTIGATOR

  • George Moschonis, Associate Professor

    La Trobe University, Bundoora, VIC 3086, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 28, 2019

Study Start

May 1, 2018

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

GR(1)