- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02158130
Effects of Aerobic Exercise Detraining (E-Mechanic_Fol)
March 21, 2016 updated by: John Apolzan, Pennington Biomedical Research Center
Effects of Aerobic Exercise Detraining on Energy Balance in Overweight Persons
The proposed study seeks to better understand the role of body weight, energy expenditure, and energy intake as mechanisms of body weight gain during detraining following aerobic exercise.
It is hypothesized that participants in the higher dose exercise group will have greater body weight gain compared to the lower exercise dose and control group from wk 24 to wk 76 follow-up.
Study Overview
Status
Completed
Conditions
Detailed Description
Eligibility criteria include having successfully completed the main E-Mechanic study, be willing to archive blood samples and not being currently enrolled in another study that may effect body, energy intake or energy expenditure.
The investigators will measure body weight, waist/hip circumference, blood pressure, body composition, physical activity, questionnaire about appetite/food intake and physical fitness.
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants that successfully enrolled and completed the E-Mechanic study and are not past 88 weeks study randomization.
Description
Inclusion Criteria:
- Completed the E-Mechanic study
- Be willing to archive blood samples
- Not participating in a study that would alter body weight, energy intake, or energy expenditure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Healthy Living
non exercise healthy living control group
|
|
General Health
Exercise Group (8 KKW) One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per week, which will result in each session lasting approximately 30 minutes.
We will recruit 1 year post study intervention.
|
|
Weight Loss
Exercise Group (20 KKW) Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session.
We will recruit 1 year post study intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Weight
Time Frame: Week 64 - 88 post study randomization
|
Fasting body weight
|
Week 64 - 88 post study randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy Expenditure
Time Frame: Week 64 - 90 since study randomization
|
Energy expenditure is calculated with the Sensewear Armband.
|
Week 64 - 90 since study randomization
|
|
Energy Intake
Time Frame: Week 64 - 90 post study randomization
|
Energy expenditure is calculated with the Sensewear Armband and furthermore, energy intake is calculated by adjusting TDEE for change in body weight following the methods used in doubly labeled water adjustment.
|
Week 64 - 90 post study randomization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Circumferences
Time Frame: Week 64-88 post study randomization
|
Waist and hip circumferences
|
Week 64-88 post study randomization
|
|
Blood Pressure
Time Frame: Week 64-88 post study randomization
|
Week 64-88 post study randomization
|
|
|
Body Composition
Time Frame: Week 64 - 88 post study randomization
|
Whole Body Scan GE iDXA (Dual energy x-ray absorptiometry)
|
Week 64 - 88 post study randomization
|
|
Triglycerides
Time Frame: Week 64 - 88 post study randomization
|
Week 64 - 88 post study randomization
|
|
|
Cholesterol
Time Frame: Week 64 - 88 post study randomization
|
Total, HDL, and LDL cholesterol
|
Week 64 - 88 post study randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John W Apolzan, PhD, PBRC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
June 4, 2014
First Submitted That Met QC Criteria
June 5, 2014
First Posted (Estimate)
June 6, 2014
Study Record Updates
Last Update Posted (Estimate)
March 22, 2016
Last Update Submitted That Met QC Criteria
March 21, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2014-028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States