Obesity Clinical Trial
Official title:
REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Randomized Trial of Assisted Exercise in Obese Endometrial Cancer Patients
This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive, supervised assisted exercise program on a stationary bike improves quality of life, increases motivation to continue to exercise, improves dietary behavior and leads to sustained weight loss in women who have had early-stage endometrial cancer. Questionnaires will be used to assess exercise motivation and dietary behavior. Brain's responses to different visual images will also be assessed.
Primary Objective:
To evaluate changes in body weight, fitness, bi-manual dexterity, exercise motivation and
self-reported eating behavior (via questionnaires) before and after a 16-week exercise
intervention (EOT) and 12 and 24 weeks post-EOT, in obese EC patients who will be randomized
to perform 'assisted' or voluntary exercise.
Secondary Objectives:
Objective 1: To objectively examine food behavior as determined by neuronal response to high-
versus low-calorie visual stimuli under fasted (hunger) and fed (satiated) states and stop/go
signaling (SST) in fed states in brain regions of interest (reward and motivation circuitry)
using blood oxygenation level dependent (BOLD) functional MRI before and after a 16-week
exercise intervention (EOT) and 12 and 24 weeks post-intervention in obese EC patients
performing 'assisted' and voluntary exercise.
Objective 2: To examine the modification of the neuronal response to high vs. low calorie
food images in regions of interest by polymorphisms in key genes (e.g., dopamine receptor and
dopamine transporter) and serum biomarkers (e.g., leptin, BDNF) involved in regulating
homeostatic and non-homeostatic energy systems.
Patients will be randomized to receive either the assisted exercise (n=60) or voluntary
exercise (n=60) group. Subjects in the voluntary group will exercise on a stationary
recumbent exercise cycle and pedal at their preferred rate. Subjects in the assisted exercise
group will cycle on the same stationary exercise bike; however, a motor will provide
assistance to the patient in order to maintain a pedaling rate 35% greater than their
voluntary rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions,
three times per week for eight weeks. The control group will be asked to complete all
exercise, body composition and fMRI testing similar to the exercise groups.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
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 | |
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 | |
Completed |
NCT05040971 -
Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes
|
Phase 3 |