Activity, Adiposity, and Appetite in Adolescents 2

NCT ID: NCT04028921

Last Updated: 2025-04-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-03

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Metabolic Disease Insulin Sensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No intervention

Intervention Type OTHER

This is a cross-sectional study; 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.

No intervention

Intervention Type OTHER

This is a cross-sectional study; 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.

No intervention

Intervention Type OTHER

This is a cross-sectional study; 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.

No intervention

Intervention Type OTHER

This is a cross-sectional study; no intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

This is a cross-sectional study; no intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Tanner Stage III-V
* Non-smoking
* Not currently involved in any other research study

Exclusion Criteria

* 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)
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Robin Shook

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robin P Shook, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Mercy Kansas City

Kansas City, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K01DK119545

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001808

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Energy Turnover and Appetite
NCT05365685 COMPLETED NA