NCT02559076

Brief Summary

The aim of the present study was to investigate the potential factors that determine preschool obesity in Al Ain, United Arab Emirates, and assess the effectiveness of a simple healthy lifestyle tool: Eat Right Emirates (ERE) adapted from the Ten Steps for Healthy Toddlers, produced in the UK by the Infant and Toddler Forum.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

September 11, 2015

Last Update Submit

September 24, 2015

Conditions

Childhood ObesityDietary Habits

Keywords

OverweightObesityPreschool childrenUnited Arab EmiratesDietary patternsBMI z-scores

Outcome Measures

Primary Outcomes (1)

  • Dietary patterns will be assessed using a food frequency questionnaire (FFQ).

    Dietary Patterns will be compared between randomized groups following intervention.

    6 months

Secondary Outcomes (1)

  • Body Mass Index

    6 months

Study Arms (2)

Ten Steps Leaflet

EXPERIMENTAL

Ten steps leaflet advice for healthy lifestyle

Behavioral: Ten Steps leaflet advice for healthy lifestyle

Usual care

NO INTERVENTION

Usual care given

Interventions

Ten Steps leaflet advice for healthy lifestyleBEHAVIORAL

Ten steps leaflet advice for healthy lifestyle

Ten Steps Leaflet

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy preschool children

You may not qualify if:

  • Pre-existing medical condition
  • Physical disability
  • Social problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric ObesityFeeding BehaviorOverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 24, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 25, 2015

Record last verified: 2015-09