ObesityNCT00503074
Starting Healthy Staying Healthy Pilot Trial
A study testing TV modification and safety and injury prevention in people with Obesity, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a reduction in toddlers' and preschoolers' exposure to television advertising leads to a change in their diet. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- TV modification and safety and injury prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2008
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must watch at least 1.5 hours of television a day on average
- Must speak English at home
- Residence in or near Seattle
Who cannot join
- Developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Health Institute, University of Washington
Seattle, Washington, 98195
About this study
The purpose of this study is to determine whether a reduction in toddlers' and preschoolers' exposure to television advertising leads to a change in their diet.
Read the detailed description
TV viewing is among the most significant features of childhood. In the past generation or two, new technologies have made media viewing more ubiquitous and frequent: 30% of children eat regularly in front of TV, one-third under 6 have TVs in their bedrooms, and 30% make TV part of bedtime routines. By the age of 2 years, 90% of children watch TV or videos regularly. Among those who watch, average viewing is 1.5 hours daily by age 2.
Yet the effects of this early viewing are poorly understood. In this study, we focus on children's diet, because children's food preferences have been shown to be easily influenced by advertising, and children's non-educational programming is heavy with advertising for poor nutritional-quality foods.
We will recruit 70 families with children ages 24-30 months and randomize them to either a television-minimization intervention (the intervention arm) or a toddler safety and injury prevention arm (the control arm). A case manager will actively work with the intervention arm participants to strategize ways of minimizing their media exposure. In addition, families in the intervention arm will get access both to a study website and to a monthly newsletter. The website and newsletter will inform participants of the potential hazards of early media exposure, and will offer tips for alternative activities and strategies for keeping children occupied while the parent gets a much-needed break. The control arm will have no case manager, but will have access to a website and newsletter that will emphasize toddler safety and injury-prevention themes. At the conclusion of the 4-month trial, we will assess (a) whether the study participants regularly accessed their respective websites; (b) whether the intervention-arm participants have different beliefs and attitudes about television for toddlers; and (c) whether fewer intervention-arm children watch TV compared to control-arm infants.
The comparison group will receive a similar intervention, except that it will not mention television viewing, and will instead focus on toddler and preschooler safety and injury-prevention topics, such as the appropriate use of car seats, smoke detectors, hot water heater temperature, safe gun storage, and other similar topics.
- Conditions
- Obesity
- Being tested
- TV modification, safety and injury prevention
- Keywords
- Diet, reducing, Television, Child Behavior
- Medical subject headings
- Obesity, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV modificationBehavioural
Parents receive a health behavior-change intervention consisting of 1 in-person visit from a case manager, followed by phone and e-mail contact at least monthly. The intervention is designed to promote healthy TV viewing, including viewing fewer commercials, by the target child aged 2-5 years old, and uses health behavior change theory and social cognitive theory.
safety and injury preventionBehavioural
Parents receive behavior-change counseling around toddler and preschooler safety and injury prevention.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Parents receive tailored health-behavior change messages designed to reduce their child's exposure to televised food commercials. Intervention is delivered by a case manager, by a website, and by periodic newsletters. Receives: Behavioral: TV modification |
| Control | Active comparator | Parents of children ages 2-5 receive behavioral-change counseling around toddler \& preschooler safety and injury prevention. Receives: Behavioral: safety and injury prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of foods frequently advertised on television (sugary cereals, sugary beverages, candy, fast food, salty snacks)
Measured: at conclusion of trial and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2008
- Study completionJul 2008
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.
- More trials run by University of WashingtonThe 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital
- Investigators
- Frederick J Zimmerman, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503074
- Sponsor's protocol ID
- 07-6609-J01
- Status last verified
- Nov 2009
- First submitted
- 16 Jul 2007
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zimmerman FJ, Ortiz SE, Christakis DA, Elkun D. The value of social-cognitive theory to reducing preschool TV viewing: a pilot randomized trial. Prev Med. 2012 Mar-Apr;54(3-4):212-8. doi: 10.1016/j.ypmed.2012.02.004. Epub 2012 Feb 14.
PubMed 22349644
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starting Healthy Staying Healthy Pilot Trial
- ClinicalTrials.gov ID
- NCT00503074
- Acronym / sponsor ID
- 07-6609-J01
- Conditions
- Obesity
- Keywords
- Diet, reducing, Television, Child Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- Jul 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 18 Jul 2007 (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 purpose of this study is to determine whether a reduction in toddlers' and preschoolers' exposure to television advertising leads to a change in their diet.
Detailed description
TV viewing is among the most significant features of childhood. In the past generation or two, new technologies have made media viewing more ubiquitous and frequent: 30% of children eat regularly in front of TV, one-third under 6 have TVs in their bedrooms, and 30% make TV part of bedtime routines. By the age of 2 years, 90% of children watch TV or videos regularly. Among those who watch, average viewing is 1.5 hours daily by age 2.
Yet the effects of this early viewing are poorly understood. In this study, we focus on children's diet, because children's food preferences have been shown to be easily influenced by advertising, and children's non-educational programming is heavy with advertising for poor nutritional-quality foods.
We will recruit 70 families with children ages 24-30 months and randomize them to either a television-minimization intervention (the intervention arm) or a toddler safety and injury prevention arm (the control arm). A case manager will actively work with the intervention arm participants to strategize ways of minimizing their media exposure. In addition, families in the intervention arm will get access both to a study website and to a monthly newsletter. The website and newsletter will inform participants of the potential hazards of early media exposure, and will offer tips for alternative activities and strategies for keeping children occupied while the parent gets a much-needed break. The control arm will have no case manager, but will have access to a website and newsletter that will emphasize toddler safety and injury-prevention themes. At the conclusion of the 4-month trial, we will assess (a) whether the study participants regularly accessed their respective websites; (b) whether the intervention-arm participants have different beliefs and attitudes about television for toddlers; and (c) whether fewer intervention-arm children watch TV compared to control-arm infants.
The comparison group will receive a similar intervention, except that it will not mention television viewing, and will instead focus on toddler and preschooler safety and injury-prevention topics, such as the appropriate use of car seats, smoke detectors, hot water heater temperature, safe gun storage, and other similar topics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: TV modificationParents receive tailored health-behavior change messages designed to reduce their child's exposure to televised food commercials. Intervention is delivered by a case manager, by a website, and by periodic newsletters. |
| Control | Active comparator | Behavioral: safety and injury preventionParents of children ages 2-5 receive behavioral-change counseling around toddler \& preschooler safety and injury prevention. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Must watch at least 1.5 hours of television a day on average
- Must speak English at home
- Residence in or near Seattle
Key exclusion criteria (1 listed)
- Developmental delay
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 |
|---|---|---|
| TV modificationParents receive a health behavior-change intervention consisting of 1 in-person visit from a case manager, followed by phone and e-mail contact at least monthly. The intervention is designed to promote healthy TV viewing, including viewing fewer commercials, by the target child aged 2-5 years old, and uses health behavior change theory and social cognitive theory. | Behavioural | 1 |
| safety and injury preventionParents receive behavior-change counseling around toddler and preschooler safety and injury prevention. | Behavioural | Control |
Primary outcome
Consumption of foods frequently advertised on television (sugary cereals, sugary beverages, candy, fast food, salty snacks)
Time frame: at conclusion of trial and 6 months post-intervention
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 20 Nov 2009.
- Derived from this study: PubMed 22349644Zimmerman FJ, Ortiz SE, Christakis DA, Elkun D. The value of social-cognitive theory to reducing preschool TV viewing: a pilot randomized trial. Prev Med. 2012 Mar-Apr;54(3-4):212-8. doi: 10.1016/j.ypmed.2012.02.004. Epub 2012 Feb 14.
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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.
Frederick J Zimmerman, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TV modification and safety and injury prevention in people with Obesity, run by University of Washington 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 3 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 20 Nov 2009. 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?
Consumption of foods frequently advertised on television (sugary cereals, sugary beverages, candy, fast food, salty snacks) (time frame: at conclusion of trial and 6 months post-intervention). 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 NCT00503074, 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 20 Nov 2009.