The Eat Right Emirates Healthy Lifestyle Study

Childhood Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559076
• Other study ID #: 14NT05
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: September 24, 2015
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

1. Do dietary patterns influence obesity risk in Emirati children aged 3-4 years?

2. Are dietary and other behaviours associated with obesity risk in Kuwaiti preschool children?

3. 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:

1. Investigation into tracking of risk factors in preschool children.

2. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• Healthy preschool children

Exclusion Criteria:

• Pre-existing medical condition

• Physical disability

• Social problems

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Dietary Habits
• Pediatric Obesity

Intervention

Behavioral:
• Ten Steps leaflet advice for healthy lifestyle
Ten steps leaflet advice for healthy lifestyle

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust	United Arab Emirates University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary patterns will be assessed using a food frequency questionnaire (FFQ).	Dietary Patterns will be compared between randomized groups following intervention.	6 months	No
Secondary	Body Mass Index	Body mass index (weight (kg)/height(m2) will be compared between randomized groups following intervention.	6 months	No