Obesity Clinical Trial
— I-CANOfficial title:
The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN)
Verified date | August 2017 |
Source | East Carolina University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will determine the health benefits of combining exercise training and increasing the amount of physical activity in daily life on the fat around the abdomen, weight, fitness and sensitivity to insulin. Volunteers will participate in one of three groups for 6 months: 1) a control group, 2) exercise training only, or 3) exercise training and increasing physical activity outside of training. The exercise training will follow the public health recommendations for exercise (150 minutes/week of moderate exercise). The group increasing physical activity along with exercise training will be asked to increase physical activity in their daily life (up to 3,000 step/day above their current levels through the use of step counters), and meetings focused on behavior modification. The investigators hypothesize that combining aerobic training and additional physical activity after training will have the most profound reduction on waist circumference and body composition.
Status | Completed |
Enrollment | 45 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age: 40 to 65 years - Body mass index: 30-40 - Sedentary status - One additional risk factor for cardiovascular disease - High waist circumference Exclusion Criteria: - Previous heart attack or stroke - Type 1 or type 2 diabetes - Resting systolic blood pressure >180 mmHg - Resting diastolic blood pressure>100 mmHg - Plans to be away from the Pitt County area more than 4 weeks in the next 6 months - Currently pregnant or plans to become pregnant - Not full-filling requirements during the screening process - Currently using weight loss medications - Gastric banding surgery |
Country | Name | City | State |
---|---|---|---|
United States | East Carolina University | Greenville | North Carolina |
Lead Sponsor | Collaborator |
---|---|
East Carolina University |
United States,
Swift DL, Dover SE, Nevels TR, Solar CA, Brophy PM, Hall TR, Houmard JA, Lutes LD. The intervention composed of aerobic training and non-exercise physical activity (I-CAN) study: Rationale, design and methods. Contemp Clin Trials. 2015 Nov;45(Pt B):435-42. doi: 10.1016/j.cct.2015.11.005. Epub 2015 Nov 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in waist circumference | Waist circumference will be measured at the natural waist (midway between the inferior border of the rib cage and the superior aspect of the iliac crest) with a Gulick tape measure. Both landmarks (the inferior border of the ribcage and the superior aspect of the iliac crest) will be marked and the distance will be measured to determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape remains horizontal; 2) the tape touches the entire circumference of the participant; 3) abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the measurement is taken at the end of normal respiration. The measurement will be repeated an additional time, and the reported value will be the average of these measurements. Both measurements must be within 0.5 cm to be considered acceptable for data purposes. | Baseline, 12 weeks, 24 weeks | |
Secondary | Change in body composition | Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass. | Baseline and 24 weeks | |
Secondary | Change in body weight | Weight will be measured using a standardized scale | Baseline, 12 weeks and 24 weeks | |
Secondary | Change in cardiorespiratory fitness | Fitness will be measured using a modified Balke protocol on a treadmill. Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes. The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion. Respiratory gases (VO2, CO2) and ventilation will be measured continuously using a True Max 2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah). | Baseline and 24 weeks | |
Secondary | Change in oral glucose tolerance (OGTT) | Insulin area under the curve (AUC) and glucose AUC will be determined from an oral glucose tolerance test | Baseline and 24 Weeks | |
Secondary | Changes in physical activity levels | Participants will wear a Sensewear accelerometer for seven consecutive days, 24-hrs/day. The amount of time spent in sedentary, light and moderate to vigorous physical activity will be calculated | Baseline, 12 weeks and 24 Weeks | |
Secondary | Change in dietary composition | Food Frequency Questionnaire (FFQ) contains approximately 105 items grouped by categories and is completed for both frequency of consumption as well as portion size selections by the individual. The questionnaire, upon completion, provides estimated daily intake values for selected nutrients (kilocalories, macronutrients, and micronutrients) and provides information on food group servings. | Baseline and 24 weeks | |
Secondary | Changes in blood lipids | Low density lipoproteins, High density lipoproteins, total cholesterol, and triglycerides will be measured | Baseline and 24 weeks | |
Secondary | Change in systemic inflammation | high sensitivity c-reactive protein will be measured at baseline and follow-up | Baseline and 24 weeks | |
Secondary | Change in oral glucose tolerance: Glucose and insulin AUC | Glucose and insulin AUC will be measured following the injestion of 75 mg glucose solution at baseline and 24 weeks | Baseline and 24 Weeks |
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