ObesityPhase 2/3NCT00185770
Reducing Television Viewing to Prevent Childhood Obesity
A Phase 2/3 study testing Reducing television and other screen time (SMART curriculum) in people with Obesity and Cardiovascular Diseases, run by Stanford University at 1 site in United States.
Trial summary
Randomized controlled trial to test the efficacy of reducing television, videotape and video game use to prevent obesity, increase physical activity, improve physical fitness, and decrease dietary fat and calorie intake among third grade children in twelve ethnically-diverse elementary schools. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Diseases
- What is being tested?
- Reducing television and other screen time (SMART curriculum)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to not given
- Phase
- Phase 2/3
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All 3rd grade students attending the participating elementary schools.
Who cannot join
- Unable to complete the study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Randomized controlled trial to test the efficacy of reducing television, videotape and video game use to prevent obesity, increase physical activity, improve physical fitness, and decrease dietary fat and calorie intake among third grade children in twelve ethnically-diverse elementary schools.
Read the detailed description
The United States has experienced dramatic increases in obesity among both children and adults. Population-based primary prevention may hold the greatest promise. Unfortunately, obesity prevention programs that have specifically attempted to reduce fat and calorie intake and increase physical activity have been relatively ineffective at reducing body fatness. As a result, there is a pressing need for innovative interventions to prevent obesity.
Children spend more time watching television and videotapes and playing video games than in any other activity except sleeping. As a result, there has been widespread speculation that television viewing might be one of the most easily modifiable causes of obesity among children. This hypothesis has broad appeal, but has been difficult to validate. Epidemiological studies have consistently found weak associations between media use and childhood obesity, and additional epidemiological studies are unlikely to help clarify these relationships.
We propose an innovative experimental model. In the current environment, in which television viewing is already so prevalent, the question of greatest clinical, practical and policy importance is: Will reducing television, videotape and video game use prevent childhood obesity? As a foundation for this proposal, we have completed two pilot studies that demonstrate (1) it is possible to significantly reduce children's television, videotape and video game use and (2) that a school-based intervention to reduce children's television, videotape and video game use may result in clinically significant decreases in adiposity.
We propose a school-based randomized controlled trial involving 12 ethnically- and socioeconomically-diverse elementary schools and approximately 900 third graders. Six schools will be randomly assigned to receive an intervention to reduce television, videotape and video game use and the other six schools will receive an attention-placebo control intervention, to minimize the potential for compensatory rivalry or resentful demoralization. Our proposed intervention model is derived directly from principles of Bandura's social cognitive theory and includes a classroom curriculum and parent newsletters. The primary intervention will be delivered throughout the third grade school year.
Survey and physical assessments of all children will occur at baseline, at the end of 3rd grade (post-test) and at the beginning and end of 4th grade (4 month and one year follow-ups, respectively). A subsample of children will participate in 4 days of activity monitoring and three 24-hour dietary recalls at baseline, post-test and one-year follow-up. Parents will be interviewed by phone.
PRIMARY HYPOTHESIS: Compared to controls, third grade children exposed to a school-based intervention to reduce time spent watching television and videotapes and playing video games, will significantly reduce their body mass index (BMI, kg/m2). In addition, triceps skinfold thickness and waist and hip ratio will be measured to further characterize changes in obesity resulting from the intervention.
SECONDARY HYPOTHESES: Children attending intervention schools will significantly decrease the amount of time they spend watching television, watching videotapes and playing video games; Children attending intervention schools will significantly increase their levels of moderate to vigorous physical activity and total physical activity; Children attending intervention schools will significantly improve their physical fitness; Children attending intervention schools will significantly reduce their fat intakes and total calorie intakes; Children attending intervention schools will significantly reduce the number of meals and snacks they eat while watching television and videotapes or playing video games.
- Conditions
- Obesity, Cardiovascular Diseases
- Being tested
- Reducing television and other screen time (SMART curriculum)
- Keywords
- Obesity prevention, Television, Screen time, Schools, Preadolescents
- Medical subject headings
- Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing television and other screen time (SMART curriculum)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
Secondary outcomes (9)
prevalence/incidence of obesity
triceps skinfold thickness
waist circumference
screen time
physical activity
cardiorespiratory fitness
dietary intake
weight concerns
academic performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 1999
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 Stanford UniversityThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Robert Wood Johnson Foundation
- Investigators
- Thomas N. Robinson, MD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185770
- Sponsor's protocol ID
- R01HL062224
- Other IDs
- R01HL062224
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Publications
Robinson TN. Television viewing and childhood obesity. Pediatr Clin North Am. 2001 Aug;48(4):1017-25. doi: 10.1016/s0031-3955(05)70354-0.
PubMed 11494635Robinson TN. Population-based obesity prevention for children and adolescents. In: Johnston FE, Foster GD (Eds.) Obesity, Growth and Development. London, UK: Smith-Gordon and Company Limited Publishers, 2001, pp.129-141.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Television Viewing to Prevent Childhood Obesity
- ClinicalTrials.gov ID
- NCT00185770
- Acronym / sponsor ID
- R01HL062224
- Conditions
- Obesity, Cardiovascular Diseases
- Keywords
- Obesity prevention, Television, Screen time, Schools, Preadolescents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Robert Wood Johnson Foundation
- Study start
- Apr 1999
- First posted
- 16 Sep 2005 (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.
Randomized controlled trial to test the efficacy of reducing television, videotape and video game use to prevent obesity, increase physical activity, improve physical fitness, and decrease dietary fat and calorie intake among third grade children in twelve ethnically-diverse elementary schools.
Detailed description
The United States has experienced dramatic increases in obesity among both children and adults. Population-based primary prevention may hold the greatest promise. Unfortunately, obesity prevention programs that have specifically attempted to reduce fat and calorie intake and increase physical activity have been relatively ineffective at reducing body fatness. As a result, there is a pressing need for innovative interventions to prevent obesity.
Children spend more time watching television and videotapes and playing video games than in any other activity except sleeping. As a result, there has been widespread speculation that television viewing might be one of the most easily modifiable causes of obesity among children. This hypothesis has broad appeal, but has been difficult to validate. Epidemiological studies have consistently found weak associations between media use and childhood obesity, and additional epidemiological studies are unlikely to help clarify these relationships.
We propose an innovative experimental model. In the current environment, in which television viewing is already so prevalent, the question of greatest clinical, practical and policy importance is: Will reducing television, videotape and video game use prevent childhood obesity? As a foundation for this proposal, we have completed two pilot studies that demonstrate (1) it is possible to significantly reduce children's television, videotape and video game use and (2) that a school-based intervention to reduce children's television, videotape and video game use may result in clinically significant decreases in adiposity.
We propose a school-based randomized controlled trial involving 12 ethnically- and socioeconomically-diverse elementary schools and approximately 900 third graders. Six schools will be randomly assigned to receive an intervention to reduce television, videotape and video game use and the other six schools will receive an attention-placebo control intervention, to minimize the potential for compensatory rivalry or resentful demoralization. Our proposed intervention model is derived directly from principles of Bandura's social cognitive theory and includes a classroom curriculum and parent newsletters. The primary intervention will be delivered throughout the third grade school year.
Survey and physical assessments of all children will occur at baseline, at the end of 3rd grade (post-test) and at the beginning and end of 4th grade (4 month and one year follow-ups, respectively). A subsample of children will participate in 4 days of activity monitoring and three 24-hour dietary recalls at baseline, post-test and one-year follow-up. Parents will be interviewed by phone.
PRIMARY HYPOTHESIS: Compared to controls, third grade children exposed to a school-based intervention to reduce time spent watching television and videotapes and playing video games, will significantly reduce their body mass index (BMI, kg/m2). In addition, triceps skinfold thickness and waist and hip ratio will be measured to further characterize changes in obesity resulting from the intervention.
SECONDARY HYPOTHESES: Children attending intervention schools will significantly decrease the amount of time they spend watching television, watching videotapes and playing video games; Children attending intervention schools will significantly increase their levels of moderate to vigorous physical activity and total physical activity; Children attending intervention schools will significantly improve their physical fitness; Children attending intervention schools will significantly reduce their fat intakes and total calorie intakes; Children attending intervention schools will significantly reduce the number of meals and snacks they eat while watching television and videotapes or playing video games.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All 3rd grade students attending the participating elementary schools.
Key exclusion criteria (1 listed)
- Unable to complete the study procedures
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 |
|---|---|---|
| Reducing television and other screen time (SMART curriculum) | Behavioural | – |
Primary outcome
body mass index
9 secondary outcomes
prevalence/incidence of obesity
triceps skinfold thickness
waist circumference
screen time
physical activity
cardiorespiratory fitness
dietary intake
weight concerns
academic performance
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 16 Sep 2005.
- Background: PubMed 11494635Robinson TN. Television viewing and childhood obesity. Pediatr Clin North Am. 2001 Aug;48(4):1017-25. doi: 10.1016/s0031-3955(05)70354-0.
- BackgroundRobinson TN. Population-based obesity prevention for children and adolescents. In: Johnston FE, Foster GD (Eds.) Obesity, Growth and Development. London, UK: Smith-Gordon and Company Limited Publishers, 2001, pp.129-141.
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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.
Thomas N. Robinson, MD, MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Reducing television and other screen time (SMART curriculum) in people with Obesity and Cardiovascular Diseases, run by Stanford University 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 16 Sep 2005. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
body mass index. 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 NCT00185770, 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 16 Sep 2005.