ObesityEffectsNCT00962247
Effect of Changing Sedentary Behavior in Youth
A study testing Television reduction device in people with Obesity, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The primary aim is to examine how reduction in sedentary behaviors influences physical activity and energy intake. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Television reduction device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- above the 85th BMI percentile
- reside in one primary household
- engage in at least 18 hours of sedentary behavior a week
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim is to examine how reduction in sedentary behaviors influences physical activity and energy intake.
Read the detailed description
Many youth find television, videos and computer games to be very reinforcing, and they choose to be sedentary rather than physically active. Sedentary behaviors can influence energy balance and body weight by reducing physical activity and increasing energy intake. Research from our laboratory has shown that reducing sedentary behavior can increase physical activity and decrease energy intake, but there is substantial variability in the response of youth to reductions in sedentary behavior. The present proposal is designed to extend our research and explore theoretical models that may help understand why youth vary in their response to increase physical activity when targeted sedentary behaviors are reduced. We hypothesize that the increase in physical activity when sedentary behaviors are reduced is related to the relative reinforcing value (RRV) of physical activity to sedentary behaviors. The RRV of physical activity is a measure of the motivation to be active in youth, and overweight youth who are inactive find physical activity relatively less reinforcing than less overweight youth. We predict that RRV of physical activity will be positively related to the substitution of total physical activity and physical activity in the moderate to vigorous intensity range for sedentary behaviors when targeted sedentary behaviors are reduced. To test this hypothesis, we will study 60 overweight and at risk for overweight 8-12 year-old youth who differ in the RRV of physical activity to sedentary behavior, with equal numbers of boys and girls, in 3 phases: baseline, and reduce television watching from baseline by 25 percent and 50 percent. Each phase will be implemented for three weeks. Order of experimental phases will be counterbalanced across subjects. It is also predicted that reducing sedentary behavior will reduce energy intake and dietary fat intake, and the reduction in energy intake will be greatest for youth with stronger association between eating with television watching and other targeted sedentary behaviors. Liking and outcome expectancy of physical activity will be studied as additional predictors of substitution of physical activity for reductions in sedentary behaviors. Developing a better understanding of why obese youth increase physical activity or decrease energy intake when sedentary behaviors are reduced is important for the treatment of pediatric obesity.
- Conditions
- Obesity
- Being tested
- Television reduction device
- Keywords
- physical activity, relative reinforcing value, sedentary behavior, obesity
- Medical subject headings
- Obesity, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Television reduction deviceDevice
A TV allowance helps turn off the television when the time limits have been met.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary; usual, 25% reduced, 50% reduced | Experimental | The initial 3 weeks of the study, children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance). The following 3 weeks children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 25% from the usual sedentary condition using a television reduction device (TV Allowance). The final 3 weeks of the study, children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 50% from the usual sedentary condition using a television reduction device (TV Allowance) Receives: Device: Television reduction device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Actigraph activity monitors were used to record physical activity over 3 days, in addition to a weekly physical activity diary. Acti-graph counts were used to estimate energy expenditure during waking hours. Counts per minute describes the average rate of counts, with 0 being at rest and higher numbers indicating more vigorous physical activity.
Measured: 3 days
Secondary outcomes (1)
Energy Intake
Resting metabolic rate was calculated using the activity data from accelerometer (Actigraph) collection. Resting metabolic rate was used to calculate estimated daily energy expenditure. Daily energy expenditure and weight change over the study period was used to estimate energy intake. If weight was stable of the nine weeks, assume energy intake = energy expenditure. A gain of a pound was estimated as equivalent to a positive balance of 3500 calories and a loss of a pound was estimated as equivalent to a negative balance of 3500 calories.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startJul 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 State University of New York at BuffaloThe 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
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Leonard Epstein, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962247
- Sponsor's protocol ID
- HD039778
- Other IDs
- 5R01HD039778
- Acronym
- Effects
- Status last verified
- Jun 2019
- First submitted
- 17 Aug 2009
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Epstein LH, Roemmich JN, Cavanaugh MD, Paluch RA. The motivation to be sedentary predicts weight change when sedentary behaviors are reduced. Int J Behav Nutr Phys Act. 2011 Feb 22;8:13. doi: 10.1186/1479-5868-8-13.
PubMed 21342518
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Changing Sedentary Behavior in Youth
- ClinicalTrials.gov ID
- NCT00962247
- Acronym / sponsor ID
- Effects / HD039778
- Conditions
- Obesity
- Keywords
- physical activity, relative reinforcing value, sedentary behavior, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Posted 24 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim is to examine how reduction in sedentary behaviors influences physical activity and energy intake.
Detailed description
Many youth find television, videos and computer games to be very reinforcing, and they choose to be sedentary rather than physically active. Sedentary behaviors can influence energy balance and body weight by reducing physical activity and increasing energy intake. Research from our laboratory has shown that reducing sedentary behavior can increase physical activity and decrease energy intake, but there is substantial variability in the response of youth to reductions in sedentary behavior. The present proposal is designed to extend our research and explore theoretical models that may help understand why youth vary in their response to increase physical activity when targeted sedentary behaviors are reduced. We hypothesize that the increase in physical activity when sedentary behaviors are reduced is related to the relative reinforcing value (RRV) of physical activity to sedentary behaviors. The RRV of physical activity is a measure of the motivation to be active in youth, and overweight youth who are inactive find physical activity relatively less reinforcing than less overweight youth. We predict that RRV of physical activity will be positively related to the substitution of total physical activity and physical activity in the moderate to vigorous intensity range for sedentary behaviors when targeted sedentary behaviors are reduced. To test this hypothesis, we will study 60 overweight and at risk for overweight 8-12 year-old youth who differ in the RRV of physical activity to sedentary behavior, with equal numbers of boys and girls, in 3 phases: baseline, and reduce television watching from baseline by 25 percent and 50 percent. Each phase will be implemented for three weeks. Order of experimental phases will be counterbalanced across subjects. It is also predicted that reducing sedentary behavior will reduce energy intake and dietary fat intake, and the reduction in energy intake will be greatest for youth with stronger association between eating with television watching and other targeted sedentary behaviors. Liking and outcome expectancy of physical activity will be studied as additional predictors of substitution of physical activity for reductions in sedentary behaviors. Developing a better understanding of why obese youth increase physical activity or decrease energy intake when sedentary behaviors are reduced is important for the treatment of pediatric obesity.
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sedentary; usual, 25% reduced, 50% reduced | Experimental | Device: Television reduction deviceThe initial 3 weeks of the study, children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance). The following 3 weeks children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 25% from the usual sedentary condition using a television reduction device (TV Allowance). The final 3 weeks of the study, children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 50% from the usual sedentary condition using a television reduction device (TV Allowance) |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- above the 85th BMI percentile
- reside in one primary household
- engage in at least 18 hours of sedentary behavior a week
Key exclusion criteria (1 listed)
- none
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 deviceA TV allowance helps turn off the television when the time limits have been met. | Device | Sedentary; usual, 25% reduced, 50% reduced |
Primary outcome
Physical Activity
Time frame: 3 days
Actigraph activity monitors were used to record physical activity over 3 days, in addition to a weekly physical activity diary. Acti-graph counts were used to estimate energy expenditure during waking hours. Counts per minute describes the average rate of counts, with 0 being at rest and higher numbers indicating more vigorous physical activity.
1 secondary outcome
Energy Intake
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21342518Epstein LH, Roemmich JN, Cavanaugh MD, Paluch RA. The motivation to be sedentary predicts weight change when sedentary behaviors are reduced. Int J Behav Nutr Phys Act. 2011 Feb 22;8:13. doi: 10.1186/1479-5868-8-13.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 device in people with Obesity, run by State University of New York at Buffalo 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 19 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Activity (time frame: 3 days). 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 NCT00962247, 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 19 Jun 2019.