- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02559076
The Eat Right Emirates Healthy Lifestyle Study (ERERCT)
Preschool Obesity in the United Arab Emirates: Determinants and the Effectiveness of the 10-step Healthy Lifestyle Tool for Toddlers- Eat Right Emirates
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy preschool children
Exclusion Criteria:
- Pre-existing medical condition
- Physical disability
- Social problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ten Steps Leaflet
Ten steps leaflet advice for healthy lifestyle
|
Ten steps leaflet advice for healthy lifestyle
|
No Intervention: Usual care
Usual care given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary patterns will be assessed using a food frequency questionnaire (FFQ).
Time Frame: 6 months
|
Dietary Patterns will be compared between randomized groups following intervention.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: 6 months
|
Body mass index (weight (kg)/height(m2) will be compared between randomized groups following intervention.
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14NT05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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