Obesity Clinical Trial
Official title:
Brain, Activity, Teens, and Exercise (BATE)
The long-term goal is to develop effective, evidence-based lifestyle interventions to prevent and treat childhood obesity and related co-morbidities. The short-term goal, and the purpose of this application, is to quantify appetite and neural mechanisms of food reward in overweight/obese (OW/OB) sedentary youth and to quantify changes following the implementation of a physical activity intervention. The central hypothesis is that appetite becomes dysregulated at low levels of physical activity via neural reward pathways, and appetite control will improve following a long-term exercise intervention. The investigators consider this project a pilot study designed to generate data to be used for future external funding opportunities, demonstrate collaboration between researchers, and test the feasibility of the protocols.
Specific Aim 1: To identify associations between neural, psychological, and hormonal appetite
control pathways using subjective and objective measures of appetite and neurocognitive
assessments of reward pre-intervention.
Hypothesis 1: There will be significant cross-modulation of appetite across neural (brain
activation), psychological (subjective hunger), and hormonal pathways (satiety biomarkers),
though the temporal relationship between each in response to feeding is unknown.
Specific Aim 2: To assess the effectiveness of a physical activity intervention on eating
behavior in adolescents; OW/OB inactive adolescents will be randomly assigned to a 3-month
exercise intervention (Exercise +Newsletter), or a control condition (Newsletter).
Hypothesis 2a: Those exposed to the exercise intervention will have greater improvements
(compared to control group) in appetite (subjective self-reported hunger and palatability
responses, and, objectively, satiety and appetite hormones glucose, insulin, ghrelin, and
leptin, and calories consumed during ad libitum meal).
Hypothesis 2B. Compared to pre-intervention, OB/OW youth in the exercise group will show
decreased reward activation in regions of the brain when making decisions about appetizing
foods compared to post-intervention when hungry and when fed. In self-control regions,
compared to pre-intervention, the investigators will observe increased activity in both
hungry and fed conditions.
At the end of the proposed study, it is the expectation that the investigators will have
collected important preliminary data regarding how long-term structured exercise acts upon
appetite and neural mechanisms related to food reward in adolescents. Findings are key not
only to interventions targeting OW/OB youth, but also to public policy and health
recommendations for the importance of physical activity in children.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |