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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2019
Source Children's Hospital of Eastern Ontario
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
TV and music
Watching TV or listening to music while running on a treadmill

Locations

Country Name City State
Canada CHEO Research Institute Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

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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