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The Eat Right Emirates Healthy Lifestyle Study (ERERCT)

Primary Purpose

Childhood Obesity, Dietary Habits

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ten Steps leaflet advice for healthy lifestyle
Sponsored by
Great Ormond Street Hospital for Children NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Overweight, Obesity, Preschool children, United Arab Emirates, Dietary patterns, BMI z-scores

Eligibility Criteria

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

Inclusion Criteria:

  • Healthy preschool children

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Ten Steps Leaflet

    Usual care

    Arm Description

    Ten steps leaflet advice for healthy lifestyle

    Usual care given

    Outcomes

    Primary Outcome Measures

    Dietary patterns will be assessed using a food frequency questionnaire (FFQ).
    Dietary Patterns will be compared between randomized groups following intervention.

    Secondary Outcome Measures

    Body Mass Index
    Body mass index (weight (kg)/height(m2) will be compared between randomized groups following intervention.

    Full Information

    First Posted
    September 11, 2015
    Last Updated
    September 24, 2015
    Sponsor
    Great Ormond Street Hospital for Children NHS Foundation Trust
    Collaborators
    United Arab Emirates University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02559076
    Brief Title
    The Eat Right Emirates Healthy Lifestyle Study
    Acronym
    ERERCT
    Official Title
    Preschool Obesity in the United Arab Emirates: Determinants and the Effectiveness of the 10-step Healthy Lifestyle Tool for Toddlers- Eat Right Emirates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Great Ormond Street Hospital for Children NHS Foundation Trust
    Collaborators
    United Arab Emirates University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Study Aims The aim of this study is to identify social, developmental and dietary risk factors, which predispose to obesity in preschool Emirati children and to 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 using an RCT study design. Primary Research Questions Do dietary patterns influence obesity risk in Emirati children aged 3-4 years? Are dietary and other behaviours associated with obesity risk in Kuwaiti preschool children? Are developmental factors, associated with obesity risk in Emirati preschool children? Secondary Research Questions 1. Does a healthy lifestyle intervention improve eating behaviour and physical activity in Emirati preschool children? Investigation Plan Determinants of obesity in children aged 3-4 years attending preschool centres in UAE will be investigated within a cross-sectional observation study. Dietary intake will be assessed using food records and questionnaires. These will be analysed to give information on dietary patterns and nutritional intake. Developmental factors, such as infant feeding and growth patterns and other lifestyle behaviours that may influence obesity risk, such as physical activity and food related behaviours, will also be evaluated using questionnaires. Obesity will be assessed using non-invasive methods to measure body size and fatness. Risk factors for CVD including blood pressure and pulse wave velocity will also be assessed using non-invasive methods. The same infants and mothers will be followed-up one year later to allow: Investigation into tracking of risk factors in preschool children. Study of the impact of risk factors on change in BMI during the preschool period. The cohort will then provide a resource to investigate the determinants of obesity in preschool children from UAE. Recruitment The study population of preschool children will be recruited from an existing sub-sample of parents who took part in a previous study in Al Ain district, Abu Dhabi. The study population will therefore be representative of the general Emirati population. Parents will be contacted prior to the study, with permission from the Ministry of Health. Data collection The potential determinants of obesity in preschool Emirati children (exposures) and effects on obesity and risk factors for CVD (outcomes) will be investigated as detailed below. Data will be collected at baseline and at follow up one year later. All measurements will be undertaken by trained team members and performed according to the UCL CNRC standard operational procedures. All testing procedures will take place on the school premises with parents present. Exposures Exposures investigated in this study include growth patterns, infant/child feeding practices, dietary patterns, appetite characteristics and dietary behaviours . Dietary Patterns and Intake Dietary patterns in mothers and children will be assessed using a food frequency questionnaire (FFQ). Mothers will also be asked to complete a 5-day food diary representative of their child's usual diet at study baseline and one-year follow up. Diaries will be analysed for all nutrients with UK dietary reference values using dietary analysis software based on food composition data from the 6th edition of McCance and Widdowson's composition of foods. Medical History and Sociodemographic Factors Information on child and parental sociodemographic characteristics and medical history will be collected using questionnaires. Parental anthropometry will be measured where possible to give a measure of genetic exposures. Lifestyle Practices Parental and child diet will be assessed using validated questionnaires. Outcome measures: Anthropometry Cardiovascular health

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity, Dietary Habits
    Keywords
    Overweight, Obesity, Preschool children, United Arab Emirates, Dietary patterns, BMI z-scores

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ten Steps Leaflet
    Arm Type
    Experimental
    Arm Description
    Ten steps leaflet advice for healthy lifestyle
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    Usual care given
    Intervention Type
    Behavioral
    Intervention Name(s)
    Ten Steps leaflet advice for healthy lifestyle
    Intervention Description
    Ten steps leaflet advice for healthy lifestyle
    Primary Outcome Measure Information:
    Title
    Dietary patterns will be assessed using a food frequency questionnaire (FFQ).
    Description
    Dietary Patterns will be compared between randomized groups following intervention.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Body Mass Index
    Description
    Body mass index (weight (kg)/height(m2) will be compared between randomized groups following intervention.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy preschool children Exclusion Criteria: Pre-existing medical condition Physical disability Social problems

    12. IPD Sharing Statement

    Learn more about this trial

    The Eat Right Emirates Healthy Lifestyle Study

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