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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

3 days

Results posted on

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

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

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

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 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.

Outcome measures

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 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.

Outcome measures

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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leonard H. Epstein

SUNY Buffalo

Phone: 716-829-3400

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place