Childhood ObesityERERCTNCT02559076
The Eat Right Emirates Healthy Lifestyle Study
A study testing Ten Steps leaflet advice for healthy lifestyle in people with Childhood Obesity and Dietary Habits, run by Great Ormond Street Hospital for Children NHS Foundation Trust.
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… Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Dietary Habits
- What is being tested?
- Ten Steps leaflet advice for healthy lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy preschool children
Who cannot join
- Pre-existing medical condition
- Physical disability
- Social problems
About this study
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
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.
Read the 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
- 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
- Conditions
- Childhood Obesity, Dietary Habits
- Being tested
- Ten Steps leaflet advice for healthy lifestyle
- Keywords
- Overweight, Obesity, Preschool children, United Arab Emirates, Dietary patterns, BMI z-scores
- Medical subject headings
- Pediatric Obesity, Feeding Behavior, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ten Steps leaflet advice for healthy lifestyleBehavioural
Ten steps leaflet advice for healthy lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Ten Steps Leaflet | Experimental | Ten steps leaflet advice for healthy lifestyle Receives: Behavioral: Ten Steps leaflet advice for healthy lifestyle |
| Usual care | No intervention | Usual care given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary patterns will be assessed using a food frequency questionnaire (FFQ).
Dietary Patterns will be compared between randomized groups following intervention.
Measured: 6 months
Secondary outcomes (1)
Body Mass Index
Body mass index (weight (kg)/height(m2) will be compared between randomized groups following intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- United Arab Emirates University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559076
- Sponsor's protocol ID
- 14NT05
- Acronym
- ERERCT
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02559076
- Acronym / sponsor ID
- ERERCT / 14NT05
- Conditions
- Childhood Obesity, Dietary Habits
- Keywords
- Overweight, Obesity, Preschool children, United Arab Emirates, Dietary patterns, BMI z-scores
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- United Arab Emirates University
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ten Steps Leaflet | Experimental | Behavioral: Ten Steps leaflet advice for healthy lifestyleTen steps leaflet advice for healthy lifestyle |
| Usual care | No intervention | –Usual care given |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy preschool children
Key exclusion criteria (3 listed)
- Pre-existing medical condition
- Physical disability
- Social problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ten Steps leaflet advice for healthy lifestyleTen steps leaflet advice for healthy lifestyle | Behavioural | Ten Steps Leaflet |
Primary outcome
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.
1 secondary outcome
Body Mass Index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ten Steps leaflet advice for healthy lifestyle in people with Childhood Obesity and Dietary Habits, run by Great Ormond Street Hospital for Children NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary patterns will be assessed using a food frequency questionnaire (FFQ). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.