- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02833051
The Impact of an Acute Bout of Exercise on Children's Eating Behaviors
January 11, 2021 updated by: Kathleen Loralee Keller, Penn State University
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- The Pennsylvania State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children ages 9-12 years old
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Collected at week 1 of the study
|
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.
|
Collected at week 2 or 3 (randomized) of the study
|
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.
|
Collected at week 2 or 3 (randomized) of the study
|
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
|
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
Time Frame: Collected at week 2 or 3 (randomized) of the study
|
Measured using ActiGraph accelerometers
|
Collected at week 2 or 3 (randomized) of the study
|
Activity-related energy expenditure - Sedentary control day
Time Frame: Collected at week 2 or 3 (randomized) of the study
|
Measured using ActiGraph accelerometers
|
Collected at week 2 or 3 (randomized) of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline submaximal fitness test performance
Time Frame: Collected at week 1 of the study
|
YMCA submaximal cycle ergometer test - American College of Sports Medicine
|
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
|
Measured by Polar Heart Rate Monitor
|
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
|
Measured by registered nurse or trained research assistant
|
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
|
Measured on the Borg Scale
|
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
|
Children's completion of the full 30 minutes of 70% intensity exercise
|
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
|
Measured using ActiGraph accelerometers
|
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
|
Measured using ActiGraph accelerometers
|
Collected at home for one week between the 2nd and 3rd laboratory visits
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liking of foods
Time Frame: Collected at week 1 and 2 of the study
|
Ratings of how much child likes specific foods used in the study test meals, completed on visual analog scales
|
Collected at week 1 and 2 of the study
|
Wanting of foods
Time Frame: Collected at week 1 and 2 of the study
|
Ratings of how much child wants to eat specific foods used in the study test meals, completed on visual analog scales
|
Collected at week 1 and 2 of the study
|
Fullness feelings
Time Frame: Collected at multiple time points during weeks 1, 2, and 3
|
Ratings of how full the child feels on a child friendly visual analog scale
|
Collected at multiple time points during weeks 1, 2, and 3
|
Height
Time Frame: Collected at week 1
|
Height in cm measured by stadiometer
|
Collected at week 1
|
Weight
Time Frame: Collected at week 1
|
Weight in kg by standard digital scale
|
Collected at week 1
|
Body fat percentage
Time Frame: Collected at week 1
|
Assessed by bioelectrical impedance analysis scale
|
Collected at week 1
|
Body mass index
Time Frame: Collected at week 1
|
Calculated from height and weight (kg/m^2)
|
Collected at week 1
|
BMI percentile
Time Frame: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
BMI z-score
Time Frame: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
Fat mass index
Time Frame: Collected at week 1
|
Calculated from body fat percentage, weight, height
|
Collected at week 1
|
Fat-free mass index
Time Frame: Collected at week 1
|
Calculated from fat mass, weight, height
|
Collected at week 1
|
Appetitive traits
Time Frame: Collected at week 1
|
Parent-reported questionnaire of habitual eating styles in children
|
Collected at week 1
|
Pubertal development
Time Frame: Collected at week 1
|
Parent-reported questionnaire
|
Collected at week 1
|
Family demographics
Time Frame: Collected at week 1
|
Parent-reported questionnaire
|
Collected at week 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
June 8, 2016
First Submitted That Met QC Criteria
July 11, 2016
First Posted (Estimate)
July 14, 2016
Study Record Updates
Last Update Posted (Actual)
January 13, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EnergyBalance01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Obesity
-
Virginia Commonwealth UniversityActive, not recruitingObesity, PediatricUnited States
-
University of British ColumbiaThe Hospital for Sick Children; Canadian Institutes of Health Research (CIHR); Alberta Health services and other collaboratorsCompleted
-
Hasselt UniversityJessa HospitalCompletedObesity, Pediatric
-
Azienda Ospedaliera Universitaria Integrata VeronaNot yet recruitingObesity, Pediatric
-
University of British ColumbiaHeart and Stroke Foundation of Canada; Public Health Agency of Canada (PHAC); Childhood Obesity Foundation and other collaboratorsCompleted
-
Columbia UniversityCompletedVitamin D Deficiency | Obesity, Morbid | Obesity, Childhood | Obesity, PediatricUnited States
-
University Hospital, Clermont-FerrandAME2P Laboratory, Clermont Auvergne UniversityCompleted
-
Medical College of WisconsinWisconsin Department of Health and Family Services; Children's Health System...TerminatedPediatric Obesity | Pediatric OverweightUnited States
-
Kahramanmaras Sutcu Imam UniversityCompletedPediatric Obesity | Pediatric DentistryTurkey
-
Central Hospital, Nancy, FranceNot yet recruiting