ObesityAAAA2NCT04028921
Activity, Adiposity, and Appetite in Adolescents 2
An observational study of Obesity and Metabolic Disease, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
Our goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. The investigators will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight and physical activity using across-sectional study design. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Obesity, Metabolic Disease, Insulin Sensitivity
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- Child
Study population: Healthy males and females.
Who may be able to join
- Tanner Stage III-V
- Non-smoking
- Not currently involved in any other research study
Who cannot join
- Restrained eater (>13) on the restraint section of the three-factor eating questionnaire; Current/past diagnosis of an eating disorder
- Gave birth in the past 12 months or <6 months post-lactation.
- Self-reported medical conditions (diabetes, Crohn's disease, etc.) that may affect adherence to the protocol or exercising safely or alter metabolism
- Medications known to affect exercise performance or metabolism (e.g. thyroid medication, beta-blockers, or stimulants)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64108
About this study
Our goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. The investigators will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight and physical activity using across-sectional study design.
Read the detailed description
Childhood obesity is the most serious public health problem of the 21st century, given the prevalence, global reach, and widespread health, economic, and social consequences. While weight gain at the most basic level is due to a chronic energy surplus, there are a host of influences that act on the energy balance system that remain largely unknown. Thus, there is a critical need to identify previously unexamined factors that may influence the energy balance system in order to develop effective interventions for prevention and treatment. Our long-term goal is to quantify the dynamic relationships between various physiological and psychological components of the energy balance system. Our short-term goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. The status quo as it relates to appetite control is that body weight status and related peripheral signals are a key regulator of energy intake. In contrast to body weight playing a primary role in energy regulation, our working hypothesis is that high levels of regular moderate-to-vigorous physical activity (MVPA) result in a metabolic phenotype consisting of enhanced metabolic function and proper regulation of appetite, which prevents the development of obesity. The investigators have reported that adults with low levels of MVPA have dysregulated appetite control, evidenced by higher levels of energy intake and elevated levels of dietary disinhibition. Additionally, the investigators have observed that rats with low fitness possess dysregulated control of appetite and reduced hepatic fat oxidation compared to rats with high fitness. Based on these findings in adults and rodents, in addition to supportive work by others, the investigators hypothesize that low levels of MVPA create a metabolic phenotype, leading to dysregulated appetite control which predisposes individuals to weight gain. To test this hypothesis the investigators will perform a study focused on the links between physical activity and appetite. The investigators will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight (normal vs overweight/obese) and physical activity (sedentary vs. active) using a 2 x 2 cross-sectional study design (N=44). The specific aim of the proposed study is: 1) To examine the association between physical activity and appetite control in adolescents, with metabolic function serving as a mediator. At the completion of the study, it is our expectation that the investigators will have described the independent effects of physical activity and body weight on energy metabolism and appetite in adolescents. This study will have a significant positive impact on the understanding of energy balance in adolescents, and will inform public health interventions that specifically target mechanisms associated with weight gain in youth.
- Conditions
- Obesity, Metabolic Disease, Insulin Sensitivity
- Being tested
- No intervention
- Medical subject headings
- Obesity, Metabolic Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a cross-sectional study; no intervention
| Study group | Role | What they receive |
|---|---|---|
| Normal weight, active | Male and female adolescents (age 14-17 years), BMI percentile >=5th to <75th for age/sex, >=60 min/day of moderate/vigorous physical activity. Receives: Other: No intervention | |
| Normal weight, sedentary | Male and female adolescents (age 14-17 years), BMI percentile >=5th to <75th for age/sex, <60 min/day of moderate/vigorous physical activity. Receives: Other: No intervention | |
| Overweight/obese, active | Male and female adolescents (age 14-17 years), BMI percentile >=85th to <99th for age/sex, >=60 min/day of moderate/vigorous physical activity. Receives: Other: No intervention | |
| Overweight/obese, sedentary | Male and female adolescents (age 14-17 years), BMI percentile >=85th to <99th for age/sex, <60 min/day of moderate/vigorous physical activity. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite- Subjective
The investigators will measure subjective appetite ratings using visual analog scales related to hunger following a fixed-calorie meal: Hunger, Area Under the Curve (AUC)
Hunger and palatability were assessed using self-rated visual analogue scales (Rogers, P. J., \& Blundell, J. E. (1993). Intense sweeteners and appetite. The American Journal of Clinical Nutrition, 58(1), 120-122.) Scale is 0-100, with 0 equaling 'I am not hungry at all' and 100 equaling 'I have never been more hungry'.
Area under the curve (AUC) was calculated for appetite variables by calculating the area of the response as you would a trapezoid.
Measured: Baseline
Appetite- Objective
The investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal.
Measured: Baseline
Appetite- Adjusted
The investigators will measure objective and subjective appetite responses as described above adjusted by insulin sensitivity (glucose infusion rate, mg/kg/min) as assessed in the euglycemic hyperinsulinemic clamp technique.
Hunger score on a scale*min adjusted for glucose infusion rate (mL/kgFFM/min) and sex
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start3 Jan 2022
- Primary completion1 Nov 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Shook, Children's Mercy Hospital Kansas City
- Investigators
- Robin P Shook, PhD, Principal investigator, Children's Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028921
- Sponsor's protocol ID
- STUDY00001808
- Other IDs
- K01DK119545
- Acronym
- AAAA2
- Status last verified
- Mar 2025
- First submitted
- 19 Jul 2019
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity, Adiposity, and Appetite in Adolescents 2
- ClinicalTrials.gov ID
- NCT04028921
- Acronym / sponsor ID
- AAAA2 / STUDY00001808
- Conditions
- Obesity, Metabolic Disease, Insulin Sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. The investigators will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight and physical activity using across-sectional study design.
Detailed description
Childhood obesity is the most serious public health problem of the 21st century, given the prevalence, global reach, and widespread health, economic, and social consequences. While weight gain at the most basic level is due to a chronic energy surplus, there are a host of influences that act on the energy balance system that remain largely unknown. Thus, there is a critical need to identify previously unexamined factors that may influence the energy balance system in order to develop effective interventions for prevention and treatment. Our long-term goal is to quantify the dynamic relationships between various physiological and psychological components of the energy balance system. Our short-term goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. The status quo as it relates to appetite control is that body weight status and related peripheral signals are a key regulator of energy intake. In contrast to body weight playing a primary role in energy regulation, our working hypothesis is that high levels of regular moderate-to-vigorous physical activity (MVPA) result in a metabolic phenotype consisting of enhanced metabolic function and proper regulation of appetite, which prevents the development of obesity. The investigators have reported that adults with low levels of MVPA have dysregulated appetite control, evidenced by higher levels of energy intake and elevated levels of dietary disinhibition. Additionally, the investigators have observed that rats with low fitness possess dysregulated control of appetite and reduced hepatic fat oxidation compared to rats with high fitness. Based on these findings in adults and rodents, in addition to supportive work by others, the investigators hypothesize that low levels of MVPA create a metabolic phenotype, leading to dysregulated appetite control which predisposes individuals to weight gain. To test this hypothesis the investigators will perform a study focused on the links between physical activity and appetite. The investigators will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight (normal vs overweight/obese) and physical activity (sedentary vs. active) using a 2 x 2 cross-sectional study design (N=44). The specific aim of the proposed study is: 1) To examine the association between physical activity and appetite control in adolescents, with metabolic function serving as a mediator. At the completion of the study, it is our expectation that the investigators will have described the independent effects of physical activity and body weight on energy metabolism and appetite in adolescents. This study will have a significant positive impact on the understanding of energy balance in adolescents, and will inform public health interventions that specifically target mechanisms associated with weight gain in youth.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal weight, active | – | Other: No interventionMale and female adolescents (age 14-17 years), BMI percentile >=5th to <75th for age/sex, >=60 min/day of moderate/vigorous physical activity. |
| Normal weight, sedentary | – | Other: No interventionMale and female adolescents (age 14-17 years), BMI percentile >=5th to <75th for age/sex, <60 min/day of moderate/vigorous physical activity. |
| Overweight/obese, active | – | Other: No interventionMale and female adolescents (age 14-17 years), BMI percentile >=85th to <99th for age/sex, >=60 min/day of moderate/vigorous physical activity. |
| Overweight/obese, sedentary | – | Other: No interventionMale and female adolescents (age 14-17 years), BMI percentile >=85th to <99th for age/sex, <60 min/day of moderate/vigorous physical activity. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Healthy males and females.
Key inclusion criteria (3 listed)
- Tanner Stage III-V
- Non-smoking
- Not currently involved in any other research study
Key exclusion criteria (4 listed)
- Restrained eater (>13) on the restraint section of the three-factor eating questionnaire; Current/past diagnosis of an eating disorder
- Gave birth in the past 12 months or <6 months post-lactation.
- Self-reported medical conditions (diabetes, Crohn's disease, etc.) that may affect adherence to the protocol or exercising safely or alter metabolism
- Medications known to affect exercise performance or metabolism (e.g. thyroid medication, beta-blockers, or stimulants)
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 |
|---|---|---|
| No interventionThis is a cross-sectional study; no intervention | Other | Normal weight, active, Normal weight, sedentary, Overweight/obese, active, Overweight/obese, sedentary |
Primary outcome
Appetite- Subjective
Time frame: Baseline
The investigators will measure subjective appetite ratings using visual analog scales related to hunger following a fixed-calorie meal: Hunger, Area Under the Curve (AUC) Hunger and palatability were assessed using self-rated visual analogue scales (Rogers, P. J., \& Blundell, J. E. (1993). Intense sweeteners and appetite. The American Journal of Clinical Nutrition, 58(1), 120-122.) Scale is 0-100, with 0 equaling 'I am not hungry at all' and 100 equaling 'I have never been more hungry'. Area under the curve (AUC) was calculated for appetite variables by calculating the area of the response as you would a trapezoid.
Appetite- Objective
Time frame: Baseline
The investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal.
Appetite- Adjusted
Time frame: Baseline
The investigators will measure objective and subjective appetite responses as described above adjusted by insulin sensitivity (glucose infusion rate, mg/kg/min) as assessed in the euglycemic hyperinsulinemic clamp technique. Hunger score on a scale*min adjusted for glucose infusion rate (mL/kgFFM/min) and sex
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Aggregated 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 P Shook, PhD principal investigator
Children's Mercy
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 Obesity and Metabolic Disease, 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 3 inclusion and 4 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 2 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Appetite- Subjective (time frame: Baseline). The study lists 3 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 2 Apr 2025.