ObesityNCT01216306
Reducing Television Viewing To Prevent Obesity in Hispanic Preschool Children
A study testing Television reduction curriculum in people with Obesity and Physical Activity, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Obesity has been linked to the development of multiple cancers, and to poorer prognoses and higher mortality rates for certain pediatric and adult cancers. Preventing obesity is therefore a major strategy to prevent new cases of cancer and to decrease cancer related morbidity and mortality. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity, Sedentary Activity
- What is being tested?
- Television reduction curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2013
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3-5 year old Hispanic children enrolled at the specific Head Start centers who have agreed to collaborate on this study
Who cannot join
- Clinically underweight, undernutrition, or failure to thrive
Trial locations and contacts
1 site in 1 country.
About this study
Obesity has been linked to the development of multiple cancers, and to poorer prognoses and higher mortality rates for certain pediatric and adult cancers. Preventing obesity is therefore a major strategy to prevent new cases of cancer and to decrease cancer related morbidity and mortality. In the US, childhood obesity is on the rise. Since childhood obesity strongly tracks into adulthood this epidemic among children greatly increases the risk of obesity and presumably cancer in adulthood. As a result, preventing childhood obesity has been selected as a major public health goal to reduce the risk and sequelae of obesity and cancer in the US.
Moreover, television (TV) viewing has been identified as a major risk factor for childhood obesity and US children spent more time watching TV than any other activity except sleep. TV viewing contributes to excess weight gain by decreasing physical activity and increasing caloric intake. The American Academy of Pediatrics (AAP) has issued national guidelines for parents to limit their children's total entertainment media time to no more than 1 to 2 hours of quality programming per day for children greater than 2 years of age. Low-income and minority children were at greater risk for exceeding this recommendation.
Read more
Few published interventions have been successful in decreasing TV viewing in children and only one was successful among preschool children. This intervention, "Fit 5 Kids" (i.e. fit by age 5 years), was a preschool curriculum designed to decrease TV viewing via age-appropriate lessons taught to the children by research staff. The curriculum also included a take-home component consisting of a newsletter with ideas for parent (for this grant, defined as the adult most responsible for the child's care, usually the mother) and child activities that complemented the school lesson plans. Although most behavioral interventions for preschoolers target parents rather than children, this curriculum was one of the few successful interventions targeted directly at children. However, Fit 5 Kids was not designed for or evaluated among Hispanic preschool children, the subpopulation of preschool children most severely affected by obesity. Moreover, no published intervention has successfully reduced both TV viewing and excess weight gain in any preschool population. In order to fill this gap, the investigators propose to evaluate a culturally adapted Fit 5 Kids TV reduction curriculum among Hispanic preschool children enrolled in the Head Start Program.
Fit 5 Kids is the TV reduction component of the Brocodile the Crocodile health promotion program. The overall goal of Fit 5 Kids is to teach the preschoolers to decrease their TV watching and encourage alternative activities such as family meals and active playtime. The primary goal of this research plan will be to conduct a pilot group randomized controlled trial evaluating the effectiveness of the adapted curriculum to reduce TV viewing and excess weight gain in low income, Hispanic preschool children
To achieve the project goals, the investigators Specific Aim includes:
- To successfully recruit forty-eight 3-5 year old Hispanic children from 4 Head Start centers each year for 3 years and conduct a group randomized controlled study of the adapted Fit 5 Kids curriculum to evaluate its effectiveness in reducing TV viewing and excess weight gain in Hispanic preschool children.
The Primary Hypothesis to be tested includes:
H1. The culturally adapted Fit 5 Kids curriculum will reduce TV viewing and excess weight gain among Hispanic preschool children.
- Conditions
- Obesity, Physical Activity, Sedentary Activity, Television Viewing
- Being tested
- Television reduction curriculum
- Keywords
- Obesity, Physical Activity, Sedentary Activity, Television viewing, Latino, Hispanic, Preschool, School, Head Start
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Television reduction curriculumBehavioural
Also called Fit 5 Kids
Students are taught the television reduction curriculum during the school day (15-30 minutes/day) 3-5 days/week over 7 weeks. Parents are invited to attend brief after-school meetings every other week to discuss reducing their children's television viewing.
| Study group | Role | What they receive |
|---|---|---|
| Television reduction curriculum | Experimental | Students are taught the television reduction curriculum during the school day and parents are invited to attend after-school meetings to discuss reducing their children's television viewing. Receives: Behavioral: Television reduction curriculum |
| Control | No intervention | Students will be taught the standard preschool curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Television viewing at follow up
Television viewing (hours) will be measured by television viewing diaries completed by the parents for up to 7-days
Measured: The follow up measurement of television viewing will occur 8-10 weeks after the start of the study
Secondary outcomes (2)
Adiposity and obesity at follow up
Body mass index calculated from measured height and weight obtained per standard protocol. Waist circumference measured per standard protocol.
Measured: The follow up measurement of television viewing will occur 8-10 weeks after the start of the study
Physical activity at follow up
Physical activity (duration and intensity) objectively measured by accelerometers for up to 7-days.
Measured: The follow up measurement of television viewing will occur 8-10 weeks after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Mendoza, Seattle Children's Hospital
- Investigators
- Jason A Mendoza, MD, MPH, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216306
- Sponsor's protocol ID
- 1K07CA131178
- Status last verified
- Dec 2013
- First submitted
- 15 Sep 2010
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ogren M, Baranowski T, Lowry SJ, Mendoza JA. Model of goal directed behavior for limiting Latino preschoolers' television viewing: validity and reliability. BMC Public Health. 2020 Feb 5;20(1):185. doi: 10.1186/s12889-020-8268-x.
PubMed 32024491Mendoza JA, Baranowski T, Jaramillo S, Fesinmeyer MD, Haaland W, Thompson D, Nicklas TA. Fit 5 Kids TV Reduction Program for Latino Preschoolers: A Cluster Randomized Controlled Trial. Am J Prev Med. 2016 May;50(5):584-592. doi: 10.1016/j.amepre.2015.09.017. Epub 2015 Nov 10.
PubMed 26572093
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Television Viewing To Prevent Obesity in Hispanic Preschool Children
- ClinicalTrials.gov ID
- NCT01216306
- Acronym / sponsor ID
- 1K07CA131178
- Conditions
- Obesity, Physical Activity, Sedentary Activity, Television Viewing
- Keywords
- Obesity, Physical Activity, Sedentary Activity, Television viewing, Latino, Hispanic, Preschool, School
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Oct 2010 (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.
Obesity has been linked to the development of multiple cancers, and to poorer prognoses and higher mortality rates for certain pediatric and adult cancers. Preventing obesity is therefore a major strategy to prevent new cases of cancer and to decrease cancer related morbidity and mortality. In the US, childhood obesity is on the rise. Since childhood obesity strongly tracks into adulthood this epidemic among children greatly increases the risk of obesity and presumably cancer in adulthood. As a result, preventing childhood obesity has been selected as a major public health goal to reduce the risk and sequelae of obesity and cancer in the US.
Moreover, television (TV) viewing has been identified as a major risk factor for childhood obesity and US children spent more time watching TV than any other activity except sleep. TV viewing contributes to excess weight gain by decreasing physical activity and increasing caloric intake. The American Academy of Pediatrics (AAP) has issued national guidelines for parents to limit their children's total entertainment media time to no more than 1 to 2 hours of quality programming per day for children greater than 2 years of age. Low-income and minority children were at greater risk for exceeding this recommendation.
Few published interventions have been successful in decreasing TV viewing in children and only one was successful among preschool children. This intervention, "Fit 5 Kids" (i.e. fit by age 5 years), was a preschool curriculum designed to decrease TV viewing via age-appropriate lessons taught to the children by research staff. The curriculum also included a take-home component consisting of a newsletter with ideas for parent (for this grant, defined as the adult most responsible for the child's care, usually the mother) and child activities that complemented the school lesson plans. Although most behavioral interventions for preschoolers target parents rather than children, this curriculum was one of the few successful interventions targeted directly at children. However, Fit 5 Kids was not designed for or evaluated among Hispanic preschool children, the subpopulation of preschool children most severely affected by obesity. Moreover, no published intervention has successfully reduced both TV viewing and excess weight gain in any preschool population. In order to fill this gap, the investigators propose to evaluate a culturally adapted Fit 5 Kids TV reduction curriculum among Hispanic preschool children enrolled in the Head Start Program.
Fit 5 Kids is the TV reduction component of the Brocodile the Crocodile health promotion program. The overall goal of Fit 5 Kids is to teach the preschoolers to decrease their TV watching and encourage alternative activities such as family meals and active playtime. The primary goal of this research plan will be to conduct a pilot group randomized controlled trial evaluating the effectiveness of the adapted curriculum to reduce TV viewing and excess weight gain in low income, Hispanic preschool children
To achieve the project goals, the investigators Specific Aim includes:
- To successfully recruit forty-eight 3-5 year old Hispanic children from 4 Head Start centers each year for 3 years and conduct a group randomized controlled study of the adapted Fit 5 Kids curriculum to evaluate its effectiveness in reducing TV viewing and excess weight gain in Hispanic preschool children.
The Primary Hypothesis to be tested includes:
H1. The culturally adapted Fit 5 Kids curriculum will reduce TV viewing and excess weight gain among Hispanic preschool children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Television reduction curriculum | Experimental | Behavioral: Television reduction curriculumStudents are taught the television reduction curriculum during the school day and parents are invited to attend after-school meetings to discuss reducing their children's television viewing. |
| Control | No intervention | –Students will be taught the standard preschool curriculum. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 3-5 year old Hispanic children enrolled at the specific Head Start centers who have agreed to collaborate on this study
Key exclusion criteria (1 listed)
- Clinically underweight, undernutrition, or failure to thrive
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 |
|---|---|---|
| Television reduction curriculumAlso: Fit 5 KidsStudents are taught the television reduction curriculum during the school day (15-30 minutes/day) 3-5 days/week over 7 weeks. Parents are invited to attend brief after-school meetings every other week to discuss reducing their children's television viewing. | Behavioural | Television reduction curriculum |
Primary outcome
Television viewing at follow up
Time frame: The follow up measurement of television viewing will occur 8-10 weeks after the start of the study
Television viewing (hours) will be measured by television viewing diaries completed by the parents for up to 7-days
2 secondary outcomes
Adiposity and obesity at follow up
Time frame: The follow up measurement of television viewing will occur 8-10 weeks after the start of the study
Physical activity at follow up
Time frame: The follow up measurement of television viewing will occur 8-10 weeks after the start of the study
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 6 Dec 2013.
- Derived from this study: PubMed 32024491Ogren M, Baranowski T, Lowry SJ, Mendoza JA. Model of goal directed behavior for limiting Latino preschoolers' television viewing: validity and reliability. BMC Public Health. 2020 Feb 5;20(1):185. doi: 10.1186/s12889-020-8268-x.
- Derived from this study: PubMed 26572093Mendoza JA, Baranowski T, Jaramillo S, Fesinmeyer MD, Haaland W, Thompson D, Nicklas TA. Fit 5 Kids TV Reduction Program for Latino Preschoolers: A Cluster Randomized Controlled Trial. Am J Prev Med. 2016 May;50(5):584-592. doi: 10.1016/j.amepre.2015.09.017. Epub 2015 Nov 10.
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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.
Jason A Mendoza, MD, MPH principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Television reduction curriculum in people with Obesity and Physical Activity, run by Seattle Children's Hospital at 1 site in United States.
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 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Television viewing at follow up (time frame: The follow up measurement of television viewing will occur 8-10 weeks after the start of the study). 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 NCT01216306, which also lists 2 linked publications.
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 6 Dec 2013.