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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.
The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN) study will investigate the effects of aerobic exercise training and increasing the amount of physical activity outside of training (Non-EX PA) on waist circumference, weight, and other cardiovascular disease risk factors in a prospective pilot trial. The investigators will randomize sedentary (<6,500 steps per day) obese adults with at least one additional cardiovascular risk factor (N= 45) to a: (1) structured aerobic exercise program with no intervention on Non-Ex PA (AERO group, N=15); (2) structured aerobic exercise program with the additional goal of increasing Non-EX PA (AERO-PA group, N=15), or (3) a non-exercise control group (CON, N=15) for 6 months. Exercise groups will participate in the same aerobic training program (50 to 75% VO2 max), designed to be consistent with public health recommendations of 150 minutes per week of moderate physical activity. Non-Ex PA in the AERO group will be tracked throughout the entire 6 month intervention with pedometers capable of counting steps, but not displaying them to the participant (blind mode capable). The AERO-PA group will progressively increase Non-Ex PA throughout intervention using pedometers (a progressive increase of 1,000 to 3,000 steps per day above baseline levels). The AERO-PA group will also participate in lifestyle counseling grounded in the principles of the behavioral change theories to determine/reinforce strategies to increase Non-Ex PA. The primary outcome measure will be change in waist circumference following the intervention. The results of this pilot study will be used to determine the efficacy/feasibility of the intervention, and power a larger trial as an R01 application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The goal of this group is to maintain their current lifestyle habits during the intervention. participants are asked to make no conscious changes to their physical activity or dietary habits. | |
| Aerobic Exercise Training | Experimental | The Aerobic training group will participate in 6 months of aerobic training and asked to make no conscious alterations in their physical activity outside of exercise session, or dietary habits |
|
| Aerobic Exercise+ Physical Activity | Experimental | The goal of this group is to perform 6 months of aerobic exercise and increase the amount of physical activity outside of their training sessions. They will be asked to make no conscious changes to their dietary habits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise Training | Behavioral | Individuals randomized to the aerobic exercise training group will participate in 6 months of supervised exercise training. Exercise dose (expressed in kilocalories per kg per week [KKW]) during aerobic training will be 8KKW in week 1, 10KKW in week 2 and 12 KKW in week 3. the exercise dose of 12KKW will be maintained throughout the intervention. Pedometers will be worn by participant in blind-mode throughout the intervention, and removed during exercise training sessions. Participants will enter information about whether they wore their pedometer on the study website. Aerobic exercise group participants will be told to make no conscious alterations to their physical activity or dietary habits |
| Measure | Description | Time Frame |
|---|---|---|
| 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 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Fat | Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass. | Baseline to 24 weeks |
| Change in Body Weight | Weight will be measured using a standardized scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damon L Swift, Ph.D. | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Carolina University | Greenville | North Carolina | 27858 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26542389 | Background | 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):435-442. doi: 10.1016/j.cct.2015.11.005. Epub 2015 Nov 2. | |
| 33867498 | Derived |
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Participant could be excluded from enrollment prior to randomization if they do not meet the criteria for enrollment, failure to comply with the requirements of the study pre-enrollment period (e.g. do not schedule study visit) or medical issues are discovered during the screening process that would make them ineligible for enrollment.
Participants were recruited from the local Greenville, NC area. Participants were recruited through flyers, the local newspaper, and email list in the Greenville area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (CON) | The goal of this group is to maintain their current lifestyle habits during the intervention. participants are asked to make no conscious changes to their physical activity or dietary habits. |
| FG001 | Aerobic Exercise Training (AERO) | The Aerobic training group will participate in 6 months of aerobic training and asked to make no conscious alterations in their physical activity outside of exercise session, or dietary habits Aerobic Exercise Training: Individuals randomized to the aerobic exercise training group will participate in 6 months of supervised exercise training. Exercise dose (expressed in kilocalories per kg per week [KKW]) during aerobic training will be 8KKW in week 1, 10KKW in week 2 and 12 KKW in week 3. the exercise dose of 12KKW will be maintained throughout the intervention. Pedometers will be worn by participant in blind-mode throughout the intervention, and removed during exercise training sessions. Participants will enter information about whether they wore their pedometer on the study website. Aerobic exercise group participants will be told to make no conscious alterations to their physical activity or dietary habits |
| FG002 | Aerobic Exercise+ Physical Activity (AERO-PA) | The goal of this group is to perform 6 months of aerobic exercise and increase the amount of physical activity outside of their training sessions. They will be asked to make no conscious changes to their dietary habits Aerobic Exercise+ Physical Activity: The Aerobic Exercise+ Physical Activity Group will participate in the same supervised exercise training intervention as the Aerobic Exercise Group, but will also increase the amount of non-exercise physical activity in their daily lives. After week 6 of intervention, participants will incrementally increase Non-Ex PA until they reach an average of 3,000 steps/day above baseline. Non-Ex PA will be increased with moderate physical activity consistent with daily living (i.e. leisurely walking in the evening, walking the dog etc.). Participants will also periodically have life-style counseling sessions with instructors with expertise in behavioral change support to their dietary habits |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The goal of this group is to maintain their current lifestyle habits during the intervention. participants are asked to make no conscious changes to their physical activity or dietary habits. |
| BG001 | Aerobic Exercise Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | cm | Baseline and 24 weeks |
|
Data were collected over the course of approximately 6 month period that participants were enrolled. This included the assessment visits and the intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (CON) | The goal of this group is to maintain their current lifestyle habits during the intervention. participants are asked to make no conscious changes to their physical activity or dietary habits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Damon Swift | University of Virginia | (434) 924-1436 | dls3s@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2013 | Mar 6, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 25, 2013 | Mar 6, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Aerobic Exercise+ Physical Activity | Behavioral | The Aerobic Exercise+ Physical Activity Group will participate in the same supervised exercise training intervention as the Aerobic Exercise Group, but will also increase the amount of non-exercise physical activity in their daily lives. After week 6 of intervention, participants will incrementally increase Non-Ex PA until they reach an average of 3,000 steps/day above baseline. Non-Ex PA will be increased with moderate physical activity consistent with daily living (i.e. leisurely walking in the evening, walking the dog etc.). Participants will also periodically have life-style counseling sessions with instructors with expertise in behavioral change support to their dietary habits |
|
| Baseline and 24 weeks |
| Change in Cardiorespiratory Fitness (L/Min) | 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 |
| Change in Insulin Sensitivity | Insulin sensitivity was measured using an oral glucose tolerance test. With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Matsuda index. Insulin sensitivity was calculated with Matsuda index: [10,000 / √glucose minute 0 x insulin minute 0) (mean glucose (OGTT) x mean insulin OGTT)]. A higher result is better. | Baseline and 24 Weeks |
| Change in Low Density Lipoprotein (LDL) | LDL level will be measured from a blood sample at baseline and follow-up. | Baseline and 24 weeks |
| Change in High Density Lipoprotein (HDL) | HDL cholesterol level will be measured from a blood sample at baseline and follow-up | Baseline and 24 Weeks |
| Change in Total Cholesterol (mg/dL) | Total cholesterol will be measured by a blood sample at baseline and 24 weeks | Baseline and 24 weeks |
| Change in Triglyceride Level | Change in triglycerides will be measured from a blood sample at baseline and 24 weeks | Baseline and 24 Weeks |
| Change in Glucose | Glucose concentration from a fasting blood sample will be measured at baseline and follow-up | Baseline and 24 weeks |
| Change in C-reactive Protein | High sensitivity c-reactive protein (inflammatory marker) will be measured at baseline and follow-up | Baseline and 24 weeks |
| Changes in Steps | Participants will wear an accelerometer for seven consecutive days, 24-hrs/day. The amount of steps will be calculated | Baseline and 24 Weeks |
| Change in Caloric Intake (Kilocalories) | 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 |
| Change in Insulin | Insulin level will be measured from a fasting blood sample at baseline and at 24 weeks | Baseline and 24 Weeks |
| Swift DL, Nevels TR, Solar CA, Brophy PM, McGee JE, Brewer SB, Clark A, Houmard JA, Lutes LD. The Effect of Aerobic Training and Increasing Nonexercise Physical Activity on Cardiometabolic Risk Factors. Med Sci Sports Exerc. 2021 Oct 1;53(10):2152-2163. doi: 10.1249/MSS.0000000000002675. |
The Aerobic training group will participate in 6 months of aerobic training and asked to make no conscious alterations in their physical activity outside of exercise session, or dietary habits Aerobic Exercise Training: Individuals randomized to the aerobic exercise training group will participate in 6 months of supervised exercise training. Exercise dose (expressed in kilocalories per kg per week [KKW]) during aerobic training will be 8KKW in week 1, 10KKW in week 2 and 12 KKW in week 3. the exercise dose of 12KKW will be maintained throughout the intervention. Pedometers will be worn by participant in blind-mode throughout the intervention, and removed during exercise training sessions. Participants will enter information about whether they wore their pedometer on the study website. Aerobic exercise group participants will be told to make no conscious alterations to their physical activity or dietary habits |
| BG002 | Aerobic Exercise+ Physical Activity | The goal of this group is to perform 6 months of aerobic exercise and increase the amount of physical activity outside of their training sessions. They will be asked to make no conscious changes to their dietary habits Aerobic Exercise+ Physical Activity: The Aerobic Exercise+ Physical Activity Group will participate in the same supervised exercise training intervention as the Aerobic Exercise Group, but will also increase the amount of non-exercise physical activity in their daily lives. After week 6 of intervention, participants will incrementally increase Non-Ex PA until they reach an average of 3,000 steps/day above baseline. Non-Ex PA will be increased with moderate physical activity consistent with daily living (i.e. leisurely walking in the evening, walking the dog etc.). Participants will also periodically have life-style counseling sessions with instructors with expertise in behavioral change support to their dietary habits |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Weight was measured on a scale at baseline and follow-up | Mean | Standard Deviation | kg |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Body fat percentage | Body fat was measured by dual x ray absorptiometry at baseline and follow-up. Body fat is expressed as percent of body mass that is fat compared to total mass | Mean | Standard Deviation | Percent |
|
| Waist circumference | Waist circumference was measured with a guilick tape measure. The distance around the waist was measured at the level of the umbilicus (belly button). This measurement was taken at baseline and follow-up | Mean | Standard Deviation | cm |
|
| Absolute fitness | Absolute fitness describes the maximal amount of O2 consumed during a maximal exercise test. Fitness is measures by indirect calorimetry | Mean | Standard Deviation | L/min |
|
| Relative Fitness | Relative fitness describes the the maximal amount of oxygen consumed during an maximal exercise test. This value is adjusted for the participants' body weight. This measurement is taken at baseline and follow-up | Mean | Standard Deviation | mL/kg/min |
|
| Glucose | Describes blood glucose concentration from a blood sample. This measurement is taken at baseline and follow-up | Mean | Standard Deviation | mg/dL |
|
| Insulin | Describes the concentration of insulin in the blood sample. This measurement is taken at baseline and follow-up | Mean | Standard Deviation | μU·mL-1 |
|
| Very low density lipoprotein | Describes the concentration of very low density lipoprotein cholesterol in the blood. This is performed at baseline and follow-up | Mean | Standard Deviation | mg/dL |
|
| Total Cholesterol | Describes the concentration of cholesterol in the blood. This is performed at baseline and follow-up | Mean | Standard Deviation | mg/dL |
|
| High density lipoprotein | Describes the concentration of high density lipoprotein cholesterol in the blood. This is performed at baseline and follow-up | Mean | Standard Deviation | mg/dL |
|
| Low density lipoprotein | Describes the concentration of low density lipoprotein cholesterol in the blood. This is performed at baseline and follow-up | Mean | Standard Deviation | mg/dL |
|
| Insulin Sensitivity | Insulin sensitivity was measured using an oral glucose tolerance test. With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Matsuda index. Insulin sensitivity was calculated with Matsuda index: [10,000 / √glucose minute 0 x insulin minute 0) (mean glucose (OGTT) x mean insulin OGTT)]. A higher result is better. | Mean | Standard Deviation | index |
|
| Triglycerides | Describes the concentration of triglycerides in the blood. This is performed at baseline and follow-up | Mean | Standard Deviation | mg/dL |
|
| C-reactive protein | measures the amount of c-reactive protein in the blood, which is a marker of inflammation. This was performed at baseline and follow-up | Mean | Standard Deviation | mg/L |
|
| baseline steps | The average of steps walked determined by accelerometry | Mean | Standard Deviation | steps/day |
|
The goal of this group is to maintain their current lifestyle habits during the intervention. participants are asked to make no conscious changes to their physical activity or dietary habits.
| OG001 | Aerobic Exercise Training | The Aerobic training group will participate in 6 months of aerobic training and asked to make no conscious alterations in their physical activity outside of exercise session, or dietary habits Aerobic Exercise Training: Individuals randomized to the aerobic exercise training group will participate in 6 months of supervised exercise training. Exercise dose (expressed in kilocalories per kg per week [KKW]) during aerobic training will be 8KKW in week 1, 10KKW in week 2 and 12 KKW in week 3. the exercise dose of 12KKW will be maintained throughout the intervention. Pedometers will be worn by participant in blind-mode throughout the intervention, and removed during exercise training sessions. Participants will enter information about whether they wore their pedometer on the study website. Aerobic exercise group participants will be told to make no conscious alterations to their physical activity or dietary habits |
| OG002 | Aerobic Exercise+ Physical Activity | The goal of this group is to perform 6 months of aerobic exercise and increase the amount of physical activity outside of their training sessions. They will be asked to make no conscious changes to their dietary habits Aerobic Exercise+ Physical Activity: The Aerobic Exercise+ Physical Activity Group will participate in the same supervised exercise training intervention as the Aerobic Exercise Group, but will also increase the amount of non-exercise physical activity in their daily lives. After week 6 of intervention, participants will incrementally increase Non-Ex PA until they reach an average of 3,000 steps/day above baseline. Non-Ex PA will be increased with moderate physical activity consistent with daily living (i.e. leisurely walking in the evening, walking the dog etc.). Participants will also periodically have life-style counseling sessions with instructors with expertise in behavioral change support to their dietary habits |
|
|
|
| Secondary | Change in Body Fat | Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass. | Posted | Least Squares Mean | 95% Confidence Interval | percent of body fat | Baseline to 24 weeks |
|
|
|
|
| Secondary | Change in Body Weight | Weight will be measured using a standardized scale | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline and 24 weeks |
|
|
|
|
| Secondary | Change in Cardiorespiratory Fitness (L/Min) | 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). | Posted | Mean | 95% Confidence Interval | Liters/minute | Baseline and 24 weeks |
|
|
|
|
| Secondary | Change in Insulin Sensitivity | Insulin sensitivity was measured using an oral glucose tolerance test. With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Matsuda index. Insulin sensitivity was calculated with Matsuda index: [10,000 / √glucose minute 0 x insulin minute 0) (mean glucose (OGTT) x mean insulin OGTT)]. A higher result is better. | Posted | Least Squares Mean | 95% Confidence Interval | Index | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Change in Low Density Lipoprotein (LDL) | LDL level will be measured from a blood sample at baseline and follow-up. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and 24 weeks |
|
|
|
|
| Secondary | Change in High Density Lipoprotein (HDL) | HDL cholesterol level will be measured from a blood sample at baseline and follow-up | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Change in Total Cholesterol (mg/dL) | Total cholesterol will be measured by a blood sample at baseline and 24 weeks | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and 24 weeks |
|
|
|
|
| Secondary | Change in Triglyceride Level | Change in triglycerides will be measured from a blood sample at baseline and 24 weeks | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Change in Glucose | Glucose concentration from a fasting blood sample will be measured at baseline and follow-up | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and 24 weeks |
|
|
|
|
| Secondary | Change in C-reactive Protein | High sensitivity c-reactive protein (inflammatory marker) will be measured at baseline and follow-up | Posted | Least Squares Mean | 95% Confidence Interval | mg/L | Baseline and 24 weeks |
|
|
|
|
| Secondary | Changes in Steps | Participants will wear an accelerometer for seven consecutive days, 24-hrs/day. The amount of steps will be calculated | Posted | Least Squares Mean | 95% Confidence Interval | steps per day | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Change in Caloric Intake (Kilocalories) | 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. | Posted | Least Squares Mean | 95% Confidence Interval | kcals | Baseline and 24 weeks |
|
|
|
|
| Secondary | Change in Insulin | Insulin level will be measured from a fasting blood sample at baseline and at 24 weeks | Posted | Least Squares Mean | 95% Confidence Interval | μU·mL-1 | Baseline and 24 Weeks |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Aerobic Exercise Training (AERO) | The Aerobic training group will participate in 6 months of aerobic training and asked to make no conscious alterations in their physical activity outside of exercise session, or dietary habits Aerobic Exercise Training: Individuals randomized to the aerobic exercise training group will participate in 6 months of supervised exercise training. Exercise dose (expressed in kilocalories per kg per week [KKW]) during aerobic training will be 8KKW in week 1, 10KKW in week 2 and 12 KKW in week 3. the exercise dose of 12KKW will be maintained throughout the intervention. Pedometers will be worn by participant in blind-mode throughout the intervention, and removed during exercise training sessions. Participants will enter information about whether they wore their pedometer on the study website. Aerobic exercise group participants will be told to make no conscious alterations to their physical activity or dietary habits | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Aerobic Exercise+ Physical Activity (AERO-PA) | The goal of this group is to perform 6 months of aerobic exercise and increase the amount of physical activity outside of their training sessions. They will be asked to make no conscious changes to their dietary habits Aerobic Exercise+ Physical Activity: The Aerobic Exercise+ Physical Activity Group will participate in the same supervised exercise training intervention as the Aerobic Exercise Group, but will also increase the amount of non-exercise physical activity in their daily lives. After week 6 of intervention, participants will incrementally increase Non-Ex PA until they reach an average of 3,000 steps/day above baseline. Non-Ex PA will be increased with moderate physical activity consistent with daily living (i.e. leisurely walking in the evening, walking the dog etc.). Participants will also periodically have life-style counseling sessions with instructors with expertise in behavioral change support to their dietary habits | 0 | 15 | 0 | 15 | 0 | 15 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Superiority |
| Change in body fat between the AERO and AERO-PA group | ANCOVA | 0.258 | Superiority |
| 0.578 |
| Superiority |
| Change in body weight between the AERO and AERO-PA groups | ANCOVA | 0.300 | Superiority |
| 0.314 |
| Superiority |
| Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups | ANCOVA | 0.041 | Superiority |
| 0.417 |
| Superiority |
| Change in insulin sensitivity between the AERO and AERO-PA groups | ANCOVA | 0.484 | Superiority |
| 0.461 |
| Superiority |
| Change in Low density lipoprotein (LDL) between AERO and AERO-PA groups | ANCOVA | 0.739 | Superiority |
| 0.895 |
| Superiority |
| ANCOVA | 0.744 | Superiority |
| 0.254 |
| Superiority |
| Change in total cholesterol (mg/dL) between AERO and AERO-PA groups | ANCOVA | 0.501 | Superiority |
| 0.422 |
| Superiority |
| Change in triglyceride level between the AERO and AERO-PA groups | ANCOVA | 0.136 | Superiority |
| 0.274 |
| Superiority |
| Change in glucose level between the AERO and AERO-PA groups | ANCOVA | 0.685 | Superiority |
| 0.652 |
| Superiority |
| Change in systemic inflammation between the AERO and AERO-PA groups | ANCOVA | 0.822 | Superiority |
| 0.648 |
| Superiority |
| Changes in steps between the AERO and AERO-PA groups | ANCOVA | <0.001 | Superiority |
| 0.215 |
| Superiority |
| Change in caloric intake (kilocalories) between the AERO and AERO-PA groups | ANCOVA | 0.957 | Superiority |
| 0.770 |
| Superiority |
| Change in insulin concentration between AERO and AERO-PA groups | ANCOVA | 0.515 | Superiority |