Healthy Clinical Trial
Official title:
Does Exercising With a Screen or Music Lead to Post-exercise Energy Compensation in Adolescents?
| NCT number | NCT03105622 |
| Other study ID # | 17/02X |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 15, 2017 |
| Est. completion date | January 15, 2018 |
| Verified date | July 2019 |
| Source | Children's Hospital of Eastern Ontario |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
OBJECTIVE AND HYPOTHESIS:
The objective of this study will be to examine the effects of watching a screen or listening
to music while exercising on acute energy intake and expenditure. It is hypothesized that the
post-exercise energy compensation will be greater in both conditions with stimuli (i.e.,
screen and music) compared with the control condition (i.e., exercise alone).
STUDY DESIGN:
Randomized, 3-condition crossover study (within-subjects experimental design).
PARTICIPANTS:
The present study will recruit 25 male adolescents between the ages of 13 and 17 years.
Participants will be recruited via advertisements and word of mouth (first come first served
approach).
OVERVIEW OF THE STUDY PROTOCOL:
Preliminary Visit The participants will attend one baseline session and three experimental
sessions. The preliminary visit will include measurements related to anthropometry (body
weight, height, waist circumference) and resting metabolic rate. Participants will also
complete questionnaires in order to better characterize them.
Experimental Sessions Each participant will be engaged in each of the following three 30-min
experimental conditions followed by an ad libitum lunch: (1) walking/jogging on a treadmill
at 60% of VO2 peak while watching a screen (exercise + screen); (2) walking/jogging on a
treadmill at 60% of VO2 peak while listening to music (exercise + music); and (3)
walking/jogging on a treadmill at 60% of VO2 peak with no other stimulus (control condition).
MEASUREMENTS:
The main measures for this study include: anthropometric measurements, food intake, appetite
sensations, energy expenditure, resting metabolic rate, and ratings of perceived exertion.
OUTCOME MEASURES:
The primary outcome measure will be post-exercise energy compensation. The food intake
outcome will be assessed by using an ad libitum test meal immediately after the conditions
and a dietary record for the remainder of the day. The energy expenditure outcome will be
assessed by using an Actical accelerometer until bedtime. The secondary outcome measures will
include appetite sensations and the ratings of perceived exertion (OMNI scale).
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | January 15, 2018 |
| Est. primary completion date | January 15, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 13 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - Male adolescents between 13 and 17 years Exclusion Criteria: - Smoking - Unstable body weight (±4 kg) during the 3 months preceding testing - Excessive alcohol intake (>15 drinks/week) - Celiac disease - Metabolic disease (e.g., thyroid disease, heart disease, diabetes) - Medication use that could interfere with the outcome variables - Irregular sleeping pattern (e.g., shift work or working overnight shifts) - Iinability to comply with the protocol. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | CHEO Research Institute | Ottawa | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital of Eastern Ontario |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Post-exercise energy compensation (kcal/day) | Energy balance for the remainder of the day (kcal/day) | Over 24 hours | |
| Secondary | Ratings of perceived exertion | OMNI scale | While running on the treadmill (time 0, 5, 10, 15, 20, 25, and 30 min) | |
| Secondary | Appetite sensations | Visual analogue scales (mm) | 4 time points: 7:45am, 10:25am, 11:05am, and 11:30am |
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