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
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
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
NCT ID
NCT02559076
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
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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