Physical ActivityAAAANCT03157063
Pilot Data Collection for Activity, Adiposity, and Appetite in Adolescents
An observational study of Physical Activity and Sedentary Lifestyle, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The goal of this study is to quantify energy metabolism using indirect calorimetry at rest, in the presence of excess energy following a meal, and in response to the demand for energy during exercise. Read more about this study
- Who is it for?
- Ages 14 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Lifestyle, Metabolism
- What is being tested?
- Data Collection Procedures
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 19 Nov 2018
- 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 14 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will include 60 adolescent males (aged 14-18 years, Tanner stages III- IV), equally enrolled based on physical activity and body weight status.
Who may be able to join
- Males (Tanner Stage III-IV), ages 14-18
- Weight stable (5% weight change) over the previous three months as assessed by self-report.
- BMI greater than 5th and less than 99th percentile
- Physically healthy for exercise as assessed by self report Physical Activity Readiness Questionnaire (PAR-Q) for children.
- For fMRI testing, all participants must be right handed and must have normal or corrected to normal vision (as they will be viewing pictures in the fMRI procedure).
Who cannot join
- History of restrained eating, eating disorders, bariatric surgery, or other significant medical diagnosis that could impact metabolism.
- Participants taking thyroid medications, beta blockers, or other stimulants (medications are known to affect physical activity level and metabolism).
- Due to fMRI procedure requirements, children with a history of Attention Deficit Hyperactivity Disorder (ADHD) or other diagnosed psychiatric issues will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64108
About this study
The goal of this study is to quantify energy metabolism using indirect calorimetry at rest, in the presence of excess energy following a meal, and in response to the demand for energy during exercise. The investigators also will examine the individual and joint associations of activity and obesity status on neurocognitive domains of appetite control. Participants will include adolescent males and females (N=80) using a 2 x 2 cross-sectional study design, stratified by body weight (normal vs overweight/obese) and physical activity level (sedentary vs. active).
Read the detailed description
The investigators hypothesize that low levels of fitness and MVPA result in impaired metabolic function in adolescents. For this pilot study, the investigators will quantify variations in metabolic characteristics using a 2 x 2 cross-sectional study design, stratified by body weight (normal vs overweight/obese) and physical activity (sedentary vs. active). The goal is to identify metabolic factors that influence the energy balance system to directly inform interventions designed to prevent or reduce the prevalence of pediatric obesity.
- Conditions
- Physical Activity, Sedentary Lifestyle, Metabolism, Energy Balance
- Being tested
- Data Collection Procedures
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data Collection ProceduresDiagnostic test
Orientation (Consent, Screening Questionnaires) Clinic Measurements Body composition, via dual energy X-ray absorptiometry (DXA) Resting metabolic rate (RMR), via indirect calorimetry; Metabolic responses to a meal, via thermic effect of feeding (TEF) Subjective aspects of eating behavior using the Three Factor Eating Questionnaire (TFEQ) and Control of Eating Questionnaire (CEQ) Appetite, via visual analogue scales (VAS) pre- and post a prepared fixed meal and hormones related to satiety and hunger (insulin, leptin, ghrelin, peptide YY, glucagon-like peptide-1) obtained during blood samples (BLOOD) from an indwelling catheter.
Home assessments - Data collected at home during a 14 day window Fitness Test (VO2submax and VO2max) and DXA functional magnetic resonance imaging (fMRI)
| Study group | Role | What they receive |
|---|---|---|
| Inactive, normal weight | Less than 30 minutes per day of moderate to vigorous physical activity (MVPA), and body mass index percentile (BMI%) between 5th to 75th percentile. Receives: Diagnostic Test: Data Collection Procedures | |
| Inactive, overweight/obese | Less than 30 minutes per day MVPA, BMI% between 85th and 99th. Receives: Diagnostic Test: Data Collection Procedures | |
| Active, normal weight | More than 60 minutes per day MVPA, BMI% between 5th and 75th. Receives: Diagnostic Test: Data Collection Procedures | |
| Active, overweight/obese | More than 60 minutes per day MVPA, BMI% between 85th and 99th. Receives: Diagnostic Test: Data Collection Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The independent effects of physical inactivity and obesity on metabolic responses (energy expenditure) at rest, after a meal, and during exercise using indirect calorimetry.
The investigators will measure energy expenditure at rest (also called resting metabolic rate), following a fixed-calorie meal (also called thermic effect of feeding), and during submaximal walking on a treadmill, all using an indirect calorimeter.
Measured: 1 year
Secondary outcomes (1)
Physical activity levels, as measured by subjective appetite ratings and hormones related to appetite, independent of obesity status.
The investigators will measure subjective appetite ratings related to hunger, fullness, etc. using visual analog scales and hormones related to appetite control following a fixed-calorie meal and buffet-style meal.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Jan 2017
- Primary completion19 Nov 2018
- Study completion19 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Sponsor
- Investigators
- Robin Shook, PhD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157063
- Sponsor's protocol ID
- 16120865
- Acronym
- AAAA
- Status last verified
- Jan 2019
- First submitted
- 1 May 2017
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: aggregate results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Data Collection for Activity, Adiposity, and Appetite in Adolescents
- ClinicalTrials.gov ID
- NCT03157063
- Acronym / sponsor ID
- AAAA / 16120865
- Conditions
- Physical Activity, Sedentary Lifestyle, Metabolism, Energy Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 17 May 2017 (actual)
- 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 goal of this study is to quantify energy metabolism using indirect calorimetry at rest, in the presence of excess energy following a meal, and in response to the demand for energy during exercise. The investigators also will examine the individual and joint associations of activity and obesity status on neurocognitive domains of appetite control. Participants will include adolescent males and females (N=80) using a 2 x 2 cross-sectional study design, stratified by body weight (normal vs overweight/obese) and physical activity level (sedentary vs. active).
Detailed description
The investigators hypothesize that low levels of fitness and MVPA result in impaired metabolic function in adolescents. For this pilot study, the investigators will quantify variations in metabolic characteristics using a 2 x 2 cross-sectional study design, stratified by body weight (normal vs overweight/obese) and physical activity (sedentary vs. active). The goal is to identify metabolic factors that influence the energy balance system to directly inform interventions designed to prevent or reduce the prevalence of pediatric obesity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inactive, normal weight | – | Diagnostic Test: Data Collection ProceduresLess than 30 minutes per day of moderate to vigorous physical activity (MVPA), and body mass index percentile (BMI%) between 5th to 75th percentile. |
| Inactive, overweight/obese | – | Diagnostic Test: Data Collection ProceduresLess than 30 minutes per day MVPA, BMI% between 85th and 99th. |
| Active, normal weight | – | Diagnostic Test: Data Collection ProceduresMore than 60 minutes per day MVPA, BMI% between 5th and 75th. |
| Active, overweight/obese | – | Diagnostic Test: Data Collection ProceduresMore than 60 minutes per day MVPA, BMI% between 85th and 99th. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will include 60 adolescent males (aged 14-18 years, Tanner stages III- IV), equally enrolled based on physical activity and body weight status.
Key inclusion criteria (5 listed)
- Males (Tanner Stage III-IV), ages 14-18
- Weight stable (5% weight change) over the previous three months as assessed by self-report.
- BMI greater than 5th and less than 99th percentile
- Physically healthy for exercise as assessed by self report Physical Activity Readiness Questionnaire (PAR-Q) for children.
- For fMRI testing, all participants must be right handed and must have normal or corrected to normal vision (as they will be viewing pictures in the fMRI procedure).
Key exclusion criteria (3 listed)
- History of restrained eating, eating disorders, bariatric surgery, or other significant medical diagnosis that could impact metabolism.
- Participants taking thyroid medications, beta blockers, or other stimulants (medications are known to affect physical activity level and metabolism).
- Due to fMRI procedure requirements, children with a history of Attention Deficit Hyperactivity Disorder (ADHD) or other diagnosed psychiatric issues will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data Collection ProceduresOrientation (Consent, Screening Questionnaires) Clinic Measurements Body composition, via dual energy X-ray absorptiometry (DXA) Resting metabolic rate (RMR), via indirect calorimetry; Metabolic responses to a meal, via thermic effect of feeding (TEF) Subjective aspects of eating behavior using the Three Factor Eating Questionnaire (TFEQ) and Control of Eating Questionnaire (CEQ) Appetite, via visual analogue scales (VAS) pre- and post a prepared fixed meal and hormones related to satiety and hunger (insulin, leptin, ghrelin, peptide YY, glucagon-like peptide-1) obtained during blood samples (BLOOD) from an indwelling catheter. Home assessments - Data collected at home during a 14 day window Fitness Test (VO2submax and VO2max) and DXA functional magnetic resonance imaging (fMRI) | Diagnostic test | Active, normal weight, Active, overweight/obese, Inactive, normal weight, Inactive, overweight/obese |
Primary outcome
The independent effects of physical inactivity and obesity on metabolic responses (energy expenditure) at rest, after a meal, and during exercise using indirect calorimetry.
Time frame: 1 year
The investigators will measure energy expenditure at rest (also called resting metabolic rate), following a fixed-calorie meal (also called thermic effect of feeding), and during submaximal walking on a treadmill, all using an indirect calorimeter.
1 secondary outcome
Physical activity levels, as measured by subjective appetite ratings and hormones related to appetite, independent of obesity status.
Time frame: 2 years
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 26 Apr 2021.
- Individual participant dataSharing planned: No. aggregate results will be shared
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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.
Robin Shook, PhD principal investigator
Children's Mercy Kansas City
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 Physical Activity and Sedentary Lifestyle, run by Children's Mercy Hospital Kansas City 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 5 inclusion and 3 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 26 Apr 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?
The independent effects of physical inactivity and obesity on metabolic responses (energy expenditure) at rest, after a meal, and during exercise using indirect calorimetry. (time frame: 1 year). 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 26 Apr 2021.