Pediatric ObesityNCT02833051
The Impact of an Acute Bout of Exercise on Children's Eating Behaviors
An observational study of Pediatric Obesity, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this project is to examine the effects of an acute bout of exercise on children's energy intake over the course of a day. Previous studies in adolescents and adults have shown exercise to be effective in decreasing short-term energy intake, with some variability. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children ages 9-12 years old
Who may be able to join
- English as a native language
- Reading at/above grade level
- Generally healthy
- Child is "normal weight" below the 85% age- and sex-specific BMI percentile
- Child has at least one biological parent classified as "overweight" or "obese" (≥ 25 kg/m^2)
- Regularly eats breakfast
Who cannot join
- Contraindications to exercise testing (as defined by the American College of Sports Medicine)
- Medical conditions
- Psychiatric conditions
- Participation in competitive sports teams (year-round or more than 3 practices / week)
- Food allergies or other dietary restrictions
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
The purpose of this project is to examine the effects of an acute bout of exercise on children's energy intake over the course of a day. Previous studies in adolescents and adults have shown exercise to be effective in decreasing short-term energy intake, with some variability. Individual characteristics such as habitual physical activity and psychological factors may influence the effect of exercise on energy intake, but these factors have yet to be examined. The investigators have assembled a multi-disciplinary team of researchers, with expertise in eating behavior, exercise, psychology, and clinical research in order to examine these questions. First, the investigators will examine the difference in energy intake at lunch, snack, and dinner meals in response to 30 minutes of imposed exercise compared to 30 minutes of rest. Second, the investigators will collect objective measures of children's habitual physical activity, child characteristics (body composition, eating behavior traits), and individual responses to the controlled exercise bout. The investigators can then examine both group and individual differences in the energy intake response to exercise. Children (ages 9-12) will be tested over the course of three visits. The key outcome will be differences in energy intake in response to exercise vs. rest. Secondary outcomes include the influence of differences in habitual physical activity, personal characteristics, and responses to the exercise bout on children's energy intake. The long term goal of this line of research is to understand the mechanisms behind the interaction between exercise and energy intake. The translational potential of this research will be to inform personalized childhood obesity prevention strategies in children at risk for overweight.
- Conditions
- Pediatric Obesity
- Medical subject headings
- Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline energy intake
Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information.
Measured: Collected at week 1 of the study
Energy intake following exercise
Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information.
Measured: Collected at week 2 or 3 (randomized) of the study
Energy intake following sedentary control
Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information.
Measured: Collected at week 2 or 3 (randomized) of the study
Activity-related energy expenditure - Baseline day
Measured using ActiGraph accelerometers
Measured: Collected in the laboratory at week 1, 2, and 3, and at home for one week between the 2nd and 3rd laboratory visits
Activity-related energy expenditure - Exercise day
Measured using ActiGraph accelerometers
Measured: Collected at week 2 or 3 (randomized) of the study
Activity-related energy expenditure - Sedentary control day
Measured using ActiGraph accelerometers
Measured: Collected at week 2 or 3 (randomized) of the study
Secondary outcomes (7)
Baseline submaximal fitness test performance
YMCA submaximal cycle ergometer test - American College of Sports Medicine
Measured: Collected at week 1 of the study
Exercise test performance (70% intensity) - Heart rate
Measured by Polar Heart Rate Monitor
Measured: Collected at week 2 or 3 (randomized) of the study
Exercise test performance (70% intensity) - Blood pressure
Measured by registered nurse or trained research assistant
Measured: Collected at week 2 or 3 (randomized) of the study
Exercise test performance (70% intensity) - Ratings of perceived exertion
Measured on the Borg Scale
Measured: Collected at week 2 or 3 (randomized) of the study
Exercise test performance (70% intensity) - Completion
Children's completion of the full 30 minutes of 70% intensity exercise
Measured: Collected at week 2 or 3 (randomized) of the study
Child sleep patterns
Measured using ActiGraph accelerometers
Measured: Collected at home for one week between the 2nd and 3rd laboratory visits
Child physical activity patterns
Measured using ActiGraph accelerometers
Measured: Collected at home for one week between the 2nd and 3rd laboratory visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Loralee Keller, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833051
- Sponsor's protocol ID
- EnergyBalance01
- Status last verified
- Jan 2021
- First submitted
- 8 Jun 2016
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Acute Bout of Exercise on Children's Eating Behaviors
- ClinicalTrials.gov ID
- NCT02833051
- Acronym / sponsor ID
- EnergyBalance01
- Conditions
- Pediatric Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to examine the effects of an acute bout of exercise on children's energy intake over the course of a day. Previous studies in adolescents and adults have shown exercise to be effective in decreasing short-term energy intake, with some variability. Individual characteristics such as habitual physical activity and psychological factors may influence the effect of exercise on energy intake, but these factors have yet to be examined. The investigators have assembled a multi-disciplinary team of researchers, with expertise in eating behavior, exercise, psychology, and clinical research in order to examine these questions. First, the investigators will examine the difference in energy intake at lunch, snack, and dinner meals in response to 30 minutes of imposed exercise compared to 30 minutes of rest. Second, the investigators will collect objective measures of children's habitual physical activity, child characteristics (body composition, eating behavior traits), and individual responses to the controlled exercise bout. The investigators can then examine both group and individual differences in the energy intake response to exercise. Children (ages 9-12) will be tested over the course of three visits. The key outcome will be differences in energy intake in response to exercise vs. rest. Secondary outcomes include the influence of differences in habitual physical activity, personal characteristics, and responses to the exercise bout on children's energy intake. The long term goal of this line of research is to understand the mechanisms behind the interaction between exercise and energy intake. The translational potential of this research will be to inform personalized childhood obesity prevention strategies in children at risk for overweight.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children ages 9-12 years old
Key inclusion criteria (6 listed)
- English as a native language
- Reading at/above grade level
- Generally healthy
- Child is "normal weight" below the 85% age- and sex-specific BMI percentile
- Child has at least one biological parent classified as "overweight" or "obese" (≥ 25 kg/m^2)
Key exclusion criteria (5 listed)
- Contraindications to exercise testing (as defined by the American College of Sports Medicine)
- Medical conditions
- Psychiatric conditions
- Participation in competitive sports teams (year-round or more than 3 practices / week)
- Food allergies or other dietary restrictions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline energy intake
Time frame: Collected at week 1 of the study
Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information.
Energy intake following exercise
Time frame: Collected at week 2 or 3 (randomized) of the study
Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information.
Energy intake following sedentary control
Time frame: Collected at week 2 or 3 (randomized) of the study
Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information.
Activity-related energy expenditure - Baseline day
Time frame: Collected in the laboratory at week 1, 2, and 3, and at home for one week between the 2nd and 3rd laboratory visits
Measured using ActiGraph accelerometers
Activity-related energy expenditure - Exercise day
Time frame: Collected at week 2 or 3 (randomized) of the study
Measured using ActiGraph accelerometers
Activity-related energy expenditure - Sedentary control day
Time frame: Collected at week 2 or 3 (randomized) of the study
Measured using ActiGraph accelerometers
7 secondary outcomes
Baseline submaximal fitness test performance
Time frame: Collected at week 1 of the study
Exercise test performance (70% intensity) - Heart rate
Time frame: Collected at week 2 or 3 (randomized) of the study
Exercise test performance (70% intensity) - Blood pressure
Time frame: Collected at week 2 or 3 (randomized) of the study
Exercise test performance (70% intensity) - Ratings of perceived exertion
Time frame: Collected at week 2 or 3 (randomized) of the study
Exercise test performance (70% intensity) - Completion
Time frame: Collected at week 2 or 3 (randomized) of the study
Child sleep patterns
Time frame: Collected at home for one week between the 2nd and 3rd laboratory visits
Child physical activity patterns
Time frame: Collected at home for one week between the 2nd and 3rd laboratory visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline energy intake (time frame: Collected at week 1 of the study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.