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NCT number NCT03227575
Study type Interventional
Source Plymouth State University
Contact Michael Brian, PhD
Phone 603-535-3108
Email msbrian@plymouth.edu
Status Recruiting
Phase N/A
Start date September 7, 2017
Completion date July 1, 2018

Clinical Trial Summary

Physical activity is shown to positively reduce the risk of developing both cardiovascular disease and type 2 diabetes. Current guidelines recommend 30-60 minutes of moderate intensity cardiorespiratory exercise five days per week. However, studies report that <40% of young adults 18-24 years achieve the recommended weekly physical activity guidelines, and close to 40% of young adults are overweight or obese. Traditional aerobic exercise and high intensity exercise have been shown to improve glycemic control in young and middle-aged sedentary adults, however, long term implementation of such exercise regimens are difficult. Recent evidence suggests that short bouts (15 minutes) of moderate intensity walking following a meal, significantly improves glycemic control in older adults with impaired glucose control. Due to the low burden of walking on participants, moderate intensity post-meal walking might be a better alternative exercise intervention to improve overall health in a sedentary population. Therefore, the purpose of this proposal is to determine if 15 minutes of post-meal walking is an effective intervention to improve glycemic control in sedentary young adults at risk for developing MetS.


Clinical Trial Description

Sedentary young adults (18-25 years) will be recruited from the community and surrounding areas of Plymouth, NH. In order to be included in the study sample, participants must meet the following criteria: a BMI > 26 and who do not participate in regular physical activity. Participants will be free of any known signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.

Questionnaires The investigators will utilize two questionnaires for the study. Investigators will use a Health History Questionnaire to assess baseline health information. Investigators will also use the International Physical Activity Questionnaire to assess current physical activity status.

Waist Circumference, Height, Body Composition, and Weight Investigators will measure waist circumference using a Gulick measuring tape. Investigators will collect height using Stadiometer scale. Weight and body composition will be collected using a Tanita Scale, which assesses weight and body composition

Blood Pressure Blood pressure will be measured utilizing manometry (blood pressure cuff), which is traditionally used by clinicians to measure blood pressure.

Garmin VivoFit Activity Monitor A Garmin VivoFit activity monitor will be used to collect daily exercise, track steps per day, and heart rate. The monitor is worn on the wrist and allows for the accurate measurement of daily physical activity, steps per day, and daily heart rate. These variables and other measurement variables from daily activity, heart rate, and daily steps will be tracked with the watch.

IV Catheter Placement An intravenous (IV) catheter will be placed into a superficial vein either at the elbow (normally where blood is drawn) or vein near the wrist (secondary option for venous blood sampling). Catheter placement will be performed by Dr. Michael Brian, who has been previously trained in phlebotomy and proper IV catheter insertion at the University of Delaware. The IV catheter is vital for completing successive blood draws during the testing visit. Professor Sandra Gamble, of the Nursing Department, will assist during data collections to ensure safe blood collections.

75g Glucose Drink A standardized 75g glucose drink will be utilized to as part of the oral glucose tolerance tests, which is a test to assess the body's response to glucose.

Blood Sample Processing A OneTouch portable blood glucose monitor will be used to assess blood glucose from whole blood samples during the study visit. The remaining whole blood will be centrifuged and the extracted serum will be stored for future insulin analysis. All serum samples will be stored in a -80 freezer until analysis.

Protocol All participants will complete an informed consent and then screened prior to being enrolled into the study (See Figure 1). As part of the initial screening visit, participants will complete a health history questionnaire, International Physical Activity Questionnaire & Sedentary Behavior Questionnaire (to assess current sedentary status), waist circumference measurement, height & weight measures, body composition, and resting blood pressure. Participants will then be randomized into two study groups (Post-Meal Walking Group, Traditional Exercise Group). A control group will be recruited separately into the study to avoid participant drop out if they are not selected into the exercise training.

Protocol All participants will complete an informed consent and then screened prior to being enrolled into the study (See Figure 1). As part of the initial screening visit, participants will complete a health history questionnaire, International Physical Activity Questionnaire & Sedentary Behavior Questionnaire (to assess current sedentary status), waist circumference measurement, height & weight measures, body composition, and resting blood pressure. Participants will then be randomized into two study groups (Post-Meal Walking Group, Traditional Exercise Group). A control group will be recruited separately into the study to avoid participant drop out if they are not selected into the exercise training.

Initial Study Visit Participants will arrive 8 hours fasted to the Health and Human Performance Laboratory (D&M 401) in the morning of the study visit. Participants will be asked to provide their three-day diet record upon arrival. Baseline measurements of height, weight, waist circumference, blood pressure, heart rate, and body composition will be made. Following the baseline measurements, Michael Brian (PhD) or a trained Phlebotomist will insert a catheter into the arm of the participant, leaving a small flexible tubing in the arm to collect blood samples throughout the protocol. A baseline blood collection will be performed to assess fasting glucose and insulin levels in the body.

Participants will then complete an oral glucose tolerance test. Participants will consume a 75g of glucose drink to measure the participant's glycemic response. Blood samples will be collected at 30, 60, and 120-minute time points following glucose consumption. Following the completion of the oral glucose tolerance test, the catheter will be removed and vitals will be check (blood pressure & heart rate). Sandra Gamble (MSN) will assist in providing additional oversight during the study visit.

4-Week Exercise Intervention Following the "Initial Study Visit," participants will be provided with detailed instructions for their intervention. Participants will be randomly divided into two groups: Post-Meal Walking Group and Traditional Exercise Group. The Control group will be recruited separately, but all data will still be collected in this group.

Throughout the 4-weeks, participants will be asked to continue their regular diet and levels of physical activity (separate from physical activity from the study).

Post-Meal Walking Group Following a 30-minute digestion period, the Post-Meal Walking Group will be instructed to walk following breakfast, lunch, and dinner at least 4 times per week (180 minutes of moderate intensity exercise/week). Participants will walk at a brisk pace for 15 minutes, as demonstrated in a previous study (5). A Garmin VivoFit activity monitor will measure their physical activity across the four-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".

Traditional Exercise Group The Traditional Exercise Group will perform aerobic and light resistance training exercise over the 4-week intervention. A group of trained Exercise and Sports Physiology students will conduct the aerobic exercise and light resistance training program three times per week (180 minutes of moderate to high intensity exercise/week). Garmin VivoFit activity monitors will measure their physical activity across the four-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit". A general exercise prescription will be used to standardized all Traditional Exercise sessions.

Control Group The participant will be instructed to maintain their current diet and levels of physical activity for four weeks. Any change in diet and physical activity level might significantly affect the study results. The Control Group will maintain their current lifestyle for four weeks. Garmin VivoFit activity monitors will measure their physical activity throughout the 4-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".

Follow-up Study Visit Participants will complete all of the measurements performed during the "Initial Study Visit" and all activity monitors will be collected.


Study Design


Related Conditions & MeSH terms


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