ObesityNCT02451410
An Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador
A study testing Nutrition and physical activity in people with Obesity and Overweight, run by Universidad de Cuenca at 9 sites in Ecuador.
Trial summary
The aim of this study is to design and evaluate an educational and behavioral intervention focused on improving nutrition and physical activity habits among preschoolers in Cuenca, Ecuador, with the overarching goal of preventing overweight/obesity and promoting the formation of healthy nutrition/physical activity… Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Underweight
- What is being tested?
- Nutrition and physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 9 sitesEcuador
- Study dates
- Sep 2015to Jun 2017
- 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 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any child attending a preschool of the municipality
Who cannot join
- Any child whose parents decline inclusion in the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Ecuador9 sites
Centro Infantil 12 de Abril
Cuenca
Centro Infantil 27 de Febrero
Cuenca
Centro Infantil 9 de Octubre
Cuenca
Centro Infantil El Arenal
Cuenca
Centro Infantil El Cebollar
Cuenca
Centro Infantil El Condor
Cuenca
Centro Infantil San Blas
Cuenca
Centro Infantil Sol de Talentos
Cuenca
Centro Infantil Totoracocha
Cuenca
About this study
Official title: Impact of an Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador
The aim of this study is to design and evaluate an educational and behavioral intervention focused on improving nutrition and physical activity habits among preschoolers in Cuenca, Ecuador, with the overarching goal of preventing overweight/obesity and promoting the formation of healthy nutrition/physical activity habits.
Read the detailed description
In Ecuador and in the city of Cuenca, the prevalence of obesity is high (approximately 22% of the population). Simultaneously, there is high prevalence of chronic malnutrition (e.g., stunting). In a previous study in school-aged children in Cuenca, the prevalence of overweight or obese was 30%.
The objective of this study is to design an intervention to improve nutrition and physical activity habits and behaviors in preschoolers. The study will begin with a baseline survey that will be used to develop the educational and behavioral intervention. The intervention will consist of didactic material for teachers, educational material for parents, and activities for the children. The investigators will carry out the intervention over the course of the school year. The intervention will be primarily delivered in the preschool setting, but will also include workshops for parents.
The investigators hope that this study will help promote the health of children in Cuenca and can be a pilot study to test similar interventions in larger populations in Ecuador.
- Conditions
- Obesity, Overweight, Underweight
- Being tested
- Nutrition and physical activity
- Keywords
- Nutrition, Physical activity, Overweight, Obesity, Malnutrition
- Medical subject headings
- Obesity, Overweight, Thinness, Motor Activity, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and physical activityOther
The investigators will design an educational and behavioral program focused on health promotion. Didactic material will be developed for teachers and educational material will be developed for parents. For children, the investigators will design educational and playtime materials that encourage healthy eating and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and physical activity | Experimental | This arm includes all preschool classes receiving the educational and behavioral intervention to improve nutrition and physical activity Receives: Other: Nutrition and physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fruit and vegetable consumption habits
Changes assessed using a pre-/post-intervention questionnaire evaluating the number of days per week fruits/vegetables were consumed as snacks at home.
Measured: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
Drinking habits
Changes assessed using a pre-/post-intervention questionnaire evaluating the number of days per week water, fruit juices, and soft drinks are consumed at home.
Measured: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
Screen time habits
Changes assessed using a pre-/post-intervention questionnaire evaluating weekly hours of time spent watching television, using the computer, and playing videogames at home.
Measured: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
Secondary outcomes (1)
Nutritional status
Changes assessed using anthropometry
Measured: 1 year. Assessment pre/post intervention (approx 9 months in between).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Cuenca
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Antioquia
- Responsible party
- Principal investigator, Victoria Abril, Universidad de Cuenca
- Investigators
- Victoria Abril, PhD, Principal investigator, Universidad de Cuenca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451410
- Sponsor's protocol ID
- Intervention1
- Status last verified
- Oct 2017
- First submitted
- 11 May 2015
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Abril V, Manuel-y-keenoy B, Sola R, Garcia JL, Nessier C, Rojas R, Donoso S, Arija V. Prevalence of overweight and obesity among 6-to 9-year-old school children in Cuenca, Ecuador: relationship with physical activity, poverty, and eating habits. Food Nutr Bull. 2013 Dec;34(4):388-401. doi: 10.1177/156482651303400404.
PubMed 24605689
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador
- ClinicalTrials.gov ID
- NCT02451410
- Acronym / sponsor ID
- Intervention1
- Conditions
- Obesity, Overweight, Underweight
- Keywords
- Nutrition, Physical activity, Overweight, Obesity, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Universidad de CuencaUniversity, hospital or other
- Collaborators
- Universidad de Antioquia
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 May 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 this study is to design and evaluate an educational and behavioral intervention focused on improving nutrition and physical activity habits among preschoolers in Cuenca, Ecuador, with the overarching goal of preventing overweight/obesity and promoting the formation of healthy nutrition/physical activity habits.
Detailed description
In Ecuador and in the city of Cuenca, the prevalence of obesity is high (approximately 22% of the population). Simultaneously, there is high prevalence of chronic malnutrition (e.g., stunting). In a previous study in school-aged children in Cuenca, the prevalence of overweight or obese was 30%.
The objective of this study is to design an intervention to improve nutrition and physical activity habits and behaviors in preschoolers. The study will begin with a baseline survey that will be used to develop the educational and behavioral intervention. The intervention will consist of didactic material for teachers, educational material for parents, and activities for the children. The investigators will carry out the intervention over the course of the school year. The intervention will be primarily delivered in the preschool setting, but will also include workshops for parents.
The investigators hope that this study will help promote the health of children in Cuenca and can be a pilot study to test similar interventions in larger populations in Ecuador.
Study design
- Primary purpose
- Prevention
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition and physical activity | Experimental | Other: Nutrition and physical activityThis arm includes all preschool classes receiving the educational and behavioral intervention to improve nutrition and physical activity |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any child attending a preschool of the municipality
Key exclusion criteria (1 listed)
- Any child whose parents decline inclusion in the study
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 |
|---|---|---|
| Nutrition and physical activityThe investigators will design an educational and behavioral program focused on health promotion. Didactic material will be developed for teachers and educational material will be developed for parents. For children, the investigators will design educational and playtime materials that encourage healthy eating and physical activity. | Other | Nutrition and physical activity |
Primary outcome
Fruit and vegetable consumption habits
Time frame: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
Changes assessed using a pre-/post-intervention questionnaire evaluating the number of days per week fruits/vegetables were consumed as snacks at home.
Drinking habits
Time frame: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
Changes assessed using a pre-/post-intervention questionnaire evaluating the number of days per week water, fruit juices, and soft drinks are consumed at home.
Screen time habits
Time frame: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
Changes assessed using a pre-/post-intervention questionnaire evaluating weekly hours of time spent watching television, using the computer, and playing videogames at home.
1 secondary outcome
Nutritional status
Time frame: 1 year. Assessment pre/post intervention (approx 9 months in between).
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 1 Nov 2017.
- Background: PubMed 24605689Abril V, Manuel-y-keenoy B, Sola R, Garcia JL, Nessier C, Rojas R, Donoso S, Arija V. Prevalence of overweight and obesity among 6-to 9-year-old school children in Cuenca, Ecuador: relationship with physical activity, poverty, and eating habits. Food Nutr Bull. 2013 Dec;34(4):388-401. doi: 10.1177/156482651303400404.
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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.
Victoria Abril, PhD principal investigator
Universidad de Cuenca
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and physical activity in people with Obesity and Overweight, run by Universidad de Cuenca at 9 sites in Ecuador.
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 1 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 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Fruit and vegetable consumption habits (time frame: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02451410, which also lists 1 linked publication.
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 1 Nov 2017.