Trial Outcomes & Findings for Effect of Changing Sedentary Behavior in Youth (NCT NCT00962247)
NCT ID: NCT00962247
Last Updated: 2019-06-19
Results Overview
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.
COMPLETED
NA
61 participants
3 days
2019-06-19
Participant Flow
Families were recruited from the Buffalo NY area. 460 families were interested in screening for the study with 271 ineligible families, 4 families who were no longer interested and 28 families who withdrew from phone screen, for a total of 157 families eligible for an orientation appointment.
Prior to enrolling in the protocol, families completed an orientation, at which eligibility and interest were assessed. Families who enrolled, first completed three weeks of monitoring on the Television reduction device to determine eligibility (at least 18 hours/week of screen use) and compliance with physical activity accelerometer use.
Participant milestones
| Measure |
Sedentary; Usual, 25% Reduced, 50% Reduced
Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
|
|---|---|
|
Usual Sedentary
STARTED
|
61
|
|
Usual Sedentary
COMPLETED
|
61
|
|
Usual Sedentary
NOT COMPLETED
|
0
|
|
25% Reduction of Sedentary Activity
STARTED
|
61
|
|
25% Reduction of Sedentary Activity
COMPLETED
|
56
|
|
25% Reduction of Sedentary Activity
NOT COMPLETED
|
5
|
|
50% Reduction of Sedentary Activity
STARTED
|
56
|
|
50% Reduction of Sedentary Activity
COMPLETED
|
56
|
|
50% Reduction of Sedentary Activity
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Sedentary; Usual, 25% Reduced, 50% Reduced
Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
|
|---|---|
|
25% Reduction of Sedentary Activity
Protocol Violation
|
4
|
|
25% Reduction of Sedentary Activity
Withdrawal by Subject
|
1
|
Baseline Characteristics
Effect of Changing Sedentary Behavior in Youth
Baseline characteristics by cohort
| Measure |
Usual Sedentary
n=56 Participants
Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
|
|---|---|
|
Age, Continuous
|
10.7 Years
STANDARD_DEVIATION 1.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Height
|
57.4 Inches
STANDARD_DEVIATION 3.7 • n=99 Participants
|
|
Weight
|
118.8 lbs
STANDARD_DEVIATION 30.5 • n=99 Participants
|
|
Body Mass Index
|
25.0 kg/m^2
STANDARD_DEVIATION 4.2 • n=99 Participants
|
|
zBMI
|
1.8 z-score
STANDARD_DEVIATION 0.4 • n=99 Participants
|
PRIMARY outcome
Timeframe: 3 daysActigraph 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.
Outcome measures
| Measure |
Usual Sedentary
n=56 Participants
Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
|
25% Sedentary Reduction
n=56 Participants
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)
Television reduction device: A TV allowance helps turn off the television when the time limits have been met.
|
50% Sedentary Reduction
n=56 Participants
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)
Television reduction device: A TV allowance helps turn off the television when the time limits have been met.
|
|---|---|---|---|
|
Physical Activity
|
576.9 counts/minute of physical activity
Standard Error 23.8
|
572.4 counts/minute of physical activity
Standard Error 25.6
|
555.7 counts/minute of physical activity
Standard Error 24.3
|
SECONDARY outcome
Timeframe: 3 daysResting 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.
Outcome measures
| Measure |
Usual Sedentary
n=56 Participants
Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
|
25% Sedentary Reduction
n=56 Participants
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)
Television reduction device: A TV allowance helps turn off the television when the time limits have been met.
|
50% Sedentary Reduction
n=56 Participants
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)
Television reduction device: A TV allowance helps turn off the television when the time limits have been met.
|
|---|---|---|---|
|
Energy Intake
|
2106.4 calories/day
Standard Error 65.7
|
2173.5 calories/day
Standard Error 65.2
|
2144.3 calories/day
Standard Error 74.6
|
Adverse Events
Usual Sedentary
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place