- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00962247
Effect of Changing Sedentary Behavior in Youth (Effects)
June 10, 2019 updated by: Leonard Epstein, State University of New York at Buffalo
The primary aim is to examine how reduction in sedentary behaviors influences physical activity and energy intake.
Study Overview
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 Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14214
- University at Buffalo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- above the 85th BMI percentile
- reside in one primary household
- engage in at least 18 hours of sedentary behavior a week
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sedentary; usual, 25% reduced, 50% reduced
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)
|
A TV allowance helps turn off the television when the time limits have been met.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy Intake
Time Frame: 3 days
|
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.
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
August 17, 2009
First Submitted That Met QC Criteria
August 18, 2009
First Posted (Estimate)
August 19, 2009
Study Record Updates
Last Update Posted (Actual)
June 19, 2019
Last Update Submitted That Met QC Criteria
June 10, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HD039778
- 5R01HD039778 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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