Weight Management (LG) Research Study
You may be eligible to participate in a research study investigating how exercise impacts the structure and metabolic function of body fat.
Who can participate?
- Men & women 18-40 years of age
- Classified as overweight / obese (Body Mass Index 25-40 kg/m2)
- Weight Stable (+/- 6 pounds for past 3 months)
- Non-smoker who is relatively healthy
- Do not currently participate in regular exercise
- Individuals not taking any medications affecting metabolism or inflammation
- Women must not be pregnant, lactating, or menopausal
You will undergo/receive:
- Supervised exercise training (4x/week) if randomized into the Exercise group.
- Body composition analyses and exercise fitness assessments
- 3 clinical visits with blood sampling and metabolic testing
- Nutritional counseling from a Registered Dietitian
STUDY DETAILS:
Preliminary Testing: If a potential subject meets the eligibility criteria after completing the general screening questionnaire, you will be asked to take part in some tests to determine if you are eligible to participate.
Remote Screening Appointment: If eligible to screen after completing the general pre-screening questionnaire, you will be contacted to set up a remote screening appointment (via phone or video) where a study team member will discuss the study in detail and will answer any questions you have relating to the study. This meeting will take about 30 minutes to 1 hour to complete.
After the study team member receives your eSignature on the informed consent document, you will be asked to complete the following:
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Detailed Medical History Questionnaire
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American College of Sports Medicine (ACSM) / American Heart Association (AHA) Health/Fitness Facility Pre-participation Questionnaire
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Godin Physical Activity Assessment
Physical Screening Appointment: This in-person visit will occur at the Kinesiology Building’s Clinical Research Suite (CRS) located on the University of Michigan’s Central Campus and will take about 1 hour to complete. At this appointment, you will complete the following:
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Height, weight, waist circumference, blood pressure, heart rate, and temperature measurements
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Resting electrocardiogram (EKG or ECG) Test
If you are deemed eligible based on the results of the preliminary testing, you will be eligible to enroll in the study.
Baseline Testing: After your eligibility is confirmed, you will undergo an in-person** baseline testing appointment at the Kinesiology Building’s CRS. This appointment will take about 1 hour to complete and will include a body composition analysis and an exercise fitness test*. This baseline testing appointment will be completed before weight loss and after the 10% weight loss is achieved.
*During the COVID-19 pandemic era prior to each Exercise Fitness Test, you will be required to take a COVID-19 test 48-96 hours before this appointment. Only subjects with a negative COVID-19 test will be eligible to continue to participate.
Clinical Visits: A series of 3 in-person** clinical visits composed of comprehensive metabolic testing will be scheduled:
- before weight loss
- after a 10% weight loss is achieved
- after regaining 5% of the weight that was lost
These clinical visit appointments will include comprehensive metabolic testing that will assess your current level of health and fitness. At these appointments we will take several blood samples, obtain a small piece of muscle from your thigh, and small piece of fat from your stomach. We will also measure your:
- blood sugar control
- resting metabolic rate
- artery blood flow
All three Clinical Visit Appointments will be identical and will take place in the Clinical Research Suite in the University of Michigan’s Kinesiology Building.
Exercise Treatment: You will be randomized into one of two different treatment groups:
- Exercise group - exercise 4 days/week (“conventional” form of physical activity like moderate/brisk walking)
- No exercise (Control)
If you are selected to be in one of the exercise groups, will be performing aerobic-type exercise (i.e. cycling, running, elliptical – you choose!) 4 days per week. You will begin a 2-3-week exercise familiarization protocol where all 4 exercise sessions a supervised by an exercise trainer. All supervised exercise sessions will take place at the “Exercise Training Center” in the School of Kinesiology at the University of Michigan. During the 2-3-week exercise familiarization, you will be required to maintain your body weight.
After the exercise familiarization, you will continue your prescribed exercise protocol where 2 of the 4 exercise sessions are supervised (the other 2 exercise sessions can be done at any location where you have access to exercise equipment).
10% Weight Loss: After completing the first clinical visit appointment, participants will work with a Registered Dietitian Nutritionist to reduce their daily caloric intake to attain a weight loss of 1-2 pounds per week until a 10% weight loss is achieved.
5% Weight Regain: After completing the second clinical visit appointment, participants will increase their daily caloric intake until half of the body weight they previously lost is regained. You will also have the option to work with a Registered Dietitian Nutritionist to lose weight you regained after the completion of the entire project.
PARTICIPATION INCENTIVES:
As a thank you for taking part in the study, a pro-rated financial compensation will be provided. A pro-rated financial compensation will be provided. You will receive $100 upon completion of the Clinical Visit #1 Appointment, $150 upon completion of the Clinical Visit #2 Appointment, and $200 upon completion of the Clinical Visit #3 Appointment (total of $450 upon completion of the entire study). No compensation will be given for completion of the Preliminary Testing Procedures (Remote Screening, Physical Screening, or Baseline Testing Appointments). Subjects randomized to the Exercise group who complete the study will get to keep their heart rate monitor that was used for data collection during the study.
** During the COVID-19 pandemic era, the day of each in-person appointment, the subject will be asked the standard University of Michigan’s COVID-19 screening questionnaire (1 – Do you have symptoms of: fever >100.4°F, feeling feverish, new shortness of breath, new cough. 2 – Do you have two of any of these symptoms: chills, muscle aches, new sore throat, new loss of sense of taste or smell, new headache. 3 - Have you had close or household contact in the last 14 days with someone recently diagnosed with COVID-19?). The participant’s temperature may also be taken upon entrance to the building using a touchless thermometer. If the subject answers “yes” to any of the above COVID-19 screening questionnaire, the in-person appointment will be cancelled or postponed.
To sign up to screen for this study, select “Weight Management Study” on our general online screening questionnaire (myumi.ch/51VM2)