Central Obesity, Obesity
Conditions
Keywords
Exercise training, Non-exercise physical activity, pedometers
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAerobic 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
BEHAVIORALAerobic 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
Sponsors
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference | Baseline and 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Fat | Baseline to 24 weeks | Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass. |
| Change in Body Weight | Baseline and 24 weeks | Weight will be measured using a standardized scale |
| Change in Cardiorespiratory Fitness (L/Min) | Baseline and 24 weeks | 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). |
| Change in Insulin Sensitivity | Baseline and 24 Weeks | 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. |
| Change in Low Density Lipoprotein (LDL) | Baseline and 24 weeks | LDL level will be measured from a blood sample at baseline and follow-up. |
| Change in High Density Lipoprotein (HDL) | Baseline and 24 Weeks | HDL cholesterol level will be measured from a blood sample at baseline and follow-up |
| Change in Total Cholesterol (mg/dL) | Baseline and 24 weeks | Total cholesterol will be measured by a blood sample at baseline and 24 weeks |
| Change in Glucose | Baseline and 24 weeks | Glucose concentration from a fasting blood sample will be measured at baseline and follow-up |
| Change in C-reactive Protein | Baseline and 24 weeks | High sensitivity c-reactive protein (inflammatory marker) will be measured at baseline and follow-up |
| Changes in Steps | Baseline and 24 Weeks | Participants will wear an accelerometer for seven consecutive days, 24-hrs/day. The amount of steps will be calculated |
| Change in Caloric Intake (Kilocalories) | Baseline and 24 weeks | 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. |
| Change in Insulin | Baseline and 24 Weeks | Insulin level will be measured from a fasting blood sample at baseline and at 24 weeks |
| Change in Triglyceride Level | Baseline and 24 Weeks | Change in triglycerides will be measured from a blood sample at baseline and 24 weeks |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the local Greenville, NC area. Participants were recruited through flyers, the local newspaper, and email list in the Greenville area.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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 | 15 |
| 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 | 15 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Injury | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 2 |
Baseline characteristics
| Characteristic | Control | Aerobic Exercise Training | Aerobic Exercise+ Physical Activity | Total |
|---|---|---|---|---|
| Absolute fitness | 2.0 L/min STANDARD_DEVIATION 0.5 | 2.1 L/min STANDARD_DEVIATION 0.6 | 2.0 L/min STANDARD_DEVIATION 5 | 2.0 L/min STANDARD_DEVIATION 5 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 15 Participants | 45 Participants |
| Age, Continuous | 54.1 years STANDARD_DEVIATION 7.5 | 49.7 years STANDARD_DEVIATION 6.5 | 54.1 years STANDARD_DEVIATION 8.3 | 52.6 years STANDARD_DEVIATION 7.6 |
| baseline steps | 4479.3 steps/day STANDARD_DEVIATION 1285.9 | 4899.3 steps/day STANDARD_DEVIATION 1186.3 | 4528.3 steps/day STANDARD_DEVIATION 1296 | 4635.6 steps/day STANDARD_DEVIATION 1242.7 |
| Body fat percentage | 44.7 Percent STANDARD_DEVIATION 4.7 | 46.1 Percent STANDARD_DEVIATION 5.2 | 46.2 Percent STANDARD_DEVIATION 6 | 45.7 Percent STANDARD_DEVIATION 5.2 |
| Body mass index | 35.3 kg/m^2 STANDARD_DEVIATION 3.8 | 36.6 kg/m^2 STANDARD_DEVIATION 5.7 | 36.2 kg/m^2 STANDARD_DEVIATION 5 | 36.0 kg/m^2 STANDARD_DEVIATION 4.8 |
| C-reactive protein | 1.8 mg/L STANDARD_DEVIATION 1 | 4.3 mg/L STANDARD_DEVIATION 3.5 | 4.0 mg/L STANDARD_DEVIATION 3.1 | 3.4 mg/L STANDARD_DEVIATION 3 |
| Glucose | 96.4 mg/dL STANDARD_DEVIATION 4.5 | 97.0 mg/dL STANDARD_DEVIATION 6.8 | 96.3 mg/dL STANDARD_DEVIATION 7.3 | 96.6 mg/dL STANDARD_DEVIATION 6.2 |
| High density lipoprotein | 47.3 mg/dL STANDARD_DEVIATION 11.2 | 45.1 mg/dL STANDARD_DEVIATION 8.8 | 58.1 mg/dL STANDARD_DEVIATION 14.9 | 50.2 mg/dL STANDARD_DEVIATION 12.9 |
| Insulin | 17.1 μU·mL-1 STANDARD_DEVIATION 7.7 | 14.4 μU·mL-1 STANDARD_DEVIATION 5.8 | 17.1 μU·mL-1 STANDARD_DEVIATION 5.8 | 16.2 μU·mL-1 STANDARD_DEVIATION 6.5 |
| Insulin Sensitivity | 2.9 index STANDARD_DEVIATION 1.4 | 4.9 index STANDARD_DEVIATION 3.7 | 3.5 index STANDARD_DEVIATION 1.5 | 3.7 index STANDARD_DEVIATION 2.5 |
| Low density lipoprotein | 112.3 mg/dL STANDARD_DEVIATION 23.9 | 204.0 mg/dL STANDARD_DEVIATION 25.5 | 208.1 mg/dL STANDARD_DEVIATION 30.4 | 200.4 mg/dL STANDARD_DEVIATION 28.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 8 Participants | 11 Participants | 31 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 15 participants | 45 participants |
| Relative Fitness | 20.0 mL/kg/min STANDARD_DEVIATION 4.6 | 20.3 mL/kg/min STANDARD_DEVIATION 3.5 | 20.4 mL/kg/min STANDARD_DEVIATION 3 | 20.2 mL/kg/min STANDARD_DEVIATION 3.7 |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 13 Participants | 37 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 2 Participants | 8 Participants |
| Total Cholesterol | 189.0 mg/dL STANDARD_DEVIATION 25.8 | 204.0 mg/dL STANDARD_DEVIATION 25.5 | 208.1 mg/dL STANDARD_DEVIATION 30.7 | 200.4 mg/dL STANDARD_DEVIATION 28.1 |
| Triglycerides | 147.7 mg/dL STANDARD_DEVIATION 63.3 | 118.3 mg/dL STANDARD_DEVIATION 59.1 | 112.9 mg/dL STANDARD_DEVIATION 49.4 | 126.3 mg/dL STANDARD_DEVIATION 58.4 |
| Very low density lipoprotein | 29.5 mg/dL STANDARD_DEVIATION 12.8 | 23.6 mg/dL STANDARD_DEVIATION 11.8 | 22.5 mg/dL STANDARD_DEVIATION 9.7 | 25.2 mg/dL STANDARD_DEVIATION 11.7 |
| Waist circumference | 106.8 cm STANDARD_DEVIATION 8.5 | 105.2 cm STANDARD_DEVIATION 10.5 | 103.6 cm STANDARD_DEVIATION 6.7 | 105.2 cm STANDARD_DEVIATION 8.6 |
| Weight | 98.6 kg STANDARD_DEVIATION 12.8 | 102.9 kg STANDARD_DEVIATION 19.8 | 97.6 kg STANDARD_DEVIATION 8.6 | 99.7 kg STANDARD_DEVIATION 14.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in Waist Circumference | -1.3 cm |
| Aerobic Exercise Training | Change in Waist Circumference | -1.9 cm |
| Aerobic Exercise+ Physical Activity | Change in Waist Circumference | -4.1 cm |
p-value: 0.074ANCOVA
Comparison: Change in waist circumference between AERO and CONp-value: 0.684ANCOVA
Comparison: Comparison between the AERO group and the AERO-PA groupp-value: 0.18ANCOVA
Secondary
Change in Body Fat
Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass.
Time frame: Baseline to 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in Body Fat | 0.071 percent of body fat |
| Aerobic Exercise Training | Change in Body Fat | -0.71 percent of body fat |
| Aerobic Exercise+ Physical Activity | Change in Body Fat | -1.35 percent of body fat |
Comparison: Change in body fat between the AERO-PA group and the CON groupp-value: 0.011ANCOVA
p-value: 0.16ANCOVA
Comparison: Change in body fat between the AERO and AERO-PA groupp-value: 0.258ANCOVA
Secondary
Change in Body Weight
Weight will be measured using a standardized scale
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in Body Weight | -0.44 kg |
| Aerobic Exercise Training | Change in Body Weight | -1.11 kg |
| Aerobic Exercise+ Physical Activity | Change in Body Weight | -2.38 kg |
Comparison: Comparison of body weight between the CON and AERO-PA groupsp-value: 0.104ANCOVA
Comparison: Change in body weight between the CON and AERO groupsp-value: 0.578ANCOVA
Comparison: Change in body weight between the AERO and AERO-PA groupsp-value: 0.3ANCOVA
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.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in Caloric Intake (Kilocalories) | -553.2 kcals |
| Aerobic Exercise Training | Change in Caloric Intake (Kilocalories) | -264.3 kcals |
| Aerobic Exercise+ Physical Activity | Change in Caloric Intake (Kilocalories) | -276.9 kcals |
Comparison: Change in kilocalories (dietary intake) between CON and AERO-PA groupp-value: 0.226ANCOVA
Comparison: Change in caloric intake between the CON and the AERO groupsp-value: 0.215ANCOVA
Comparison: Change in caloric intake (kilocalories) between the AERO and AERO-PA groupsp-value: 0.957ANCOVA
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).
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Change in Cardiorespiratory Fitness (L/Min) | 0.01 Liters/minute |
| Aerobic Exercise Training | Change in Cardiorespiratory Fitness (L/Min) | 0.094 Liters/minute |
| Aerobic Exercise+ Physical Activity | Change in Cardiorespiratory Fitness (L/Min) | 0.28 Liters/minute |
Comparison: Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groupsp-value: 0.002ANCOVA
Comparison: Change in cardiorespiratory fitness (L/min) AERO and CON groupsp-value: 0.314ANCOVA
Comparison: Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groupsp-value: 0.041ANCOVA
Secondary
Change in C-reactive Protein
High sensitivity c-reactive protein (inflammatory marker) will be measured at baseline and follow-up
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in C-reactive Protein | 0.83 mg/L |
| Aerobic Exercise Training | Change in C-reactive Protein | 0.51 mg/L |
| Aerobic Exercise+ Physical Activity | Change in C-reactive Protein | 0.34 mg/L |
Comparison: Change in systemic inflammation between CON and AERO-PA groupsp-value: 0.489ANCOVA
Comparison: Change in systemic inflammation between the CON and AERO groupsp-value: 0.652ANCOVA
Comparison: Change in systemic inflammation between the AERO and AERO-PA groupsp-value: 0.822ANCOVA
Secondary
Change in Glucose
Glucose concentration from a fasting blood sample will be measured at baseline and follow-up
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in Glucose | 1.0 mg/dL |
| Aerobic Exercise Training | Change in Glucose | -1.6 mg/dL |
| Aerobic Exercise+ Physical Activity | Change in Glucose | -0.62 mg/dL |
Comparison: Change in glucose level between the CON and AERO-PA groupsp-value: 0.483ANCOVA
Comparison: Change in glucose between the CON and AERO groupsp-value: 0.274ANCOVA
Comparison: Change in glucose level between the AERO and AERO-PA groupsp-value: 0.685ANCOVA
Secondary
Change in High Density Lipoprotein (HDL)
HDL cholesterol level will be measured from a blood sample at baseline and follow-up
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in High Density Lipoprotein (HDL) | -1.9 mg/dL |
| Aerobic Exercise Training | Change in High Density Lipoprotein (HDL) | -2.2 mg/dL |
| Aerobic Exercise+ Physical Activity | Change in High Density Lipoprotein (HDL) | -1.4 mg/dL |
Comparison: Change in high density lipoprotein (HDL) between the CON and AERO-PA groupp-value: 0.837ANCOVA
Comparison: Change in high density lipoprotein (HDL) between the CON and AERO groupsp-value: 0.895ANCOVA
p-value: 0.744ANCOVA
Secondary
Change in Insulin
Insulin level will be measured from a fasting blood sample at baseline and at 24 weeks
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in Insulin | -3.7 μU·mL-1 |
| Aerobic Exercise Training | Change in Insulin | -3.2 μU·mL-1 |
| Aerobic Exercise+ Physical Activity | Change in Insulin | -1.9 μU·mL-1 |
Comparison: Change in insulin concentration between the CON and AERO-PA groupp-value: 0.337ANCOVA
Comparison: Change in insulin level between the AERO and CON groupsp-value: 0.77ANCOVA
Comparison: Change in insulin concentration between AERO and AERO-PA groupsp-value: 0.515ANCOVA
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.
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in Insulin Sensitivity | 0.84 Index |
| Aerobic Exercise Training | Change in Insulin Sensitivity | 0.25 Index |
| Aerobic Exercise+ Physical Activity | Change in Insulin Sensitivity | 0.75 Index |
Comparison: Change in insulin sensitivity between the CON and AERO-PA groupsp-value: 0.891ANCOVA
Comparison: Change in insulin sensitivity between the CON and AERO groupsp-value: 0.417ANCOVA
Comparison: Change in insulin sensitivity between the AERO and AERO-PA groupsp-value: 0.484ANCOVA
Secondary
Change in Low Density Lipoprotein (LDL)
LDL level will be measured from a blood sample at baseline and follow-up.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in Low Density Lipoprotein (LDL) | 2.2 mg/dL |
| Aerobic Exercise Training | Change in Low Density Lipoprotein (LDL) | -5.2 mg/dL |
| Aerobic Exercise+ Physical Activity | Change in Low Density Lipoprotein (LDL) | -8.7 mg/dL |
Comparison: Change in Low density lipoprotein (LDL) between the CON and the AERO groupsp-value: 0.274ANCOVA
Comparison: Change in Low density lipoprotein (LDL) between the CON and AERO groupsp-value: 0.461ANCOVA
Comparison: Change in Low density lipoprotein (LDL) between AERO and AERO-PA groupsp-value: 0.739ANCOVA
Secondary
Change in Total Cholesterol (mg/dL)
Total cholesterol will be measured by a blood sample at baseline and 24 weeks
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in Total Cholesterol (mg/dL) | 6.1 mg/dL |
| Aerobic Exercise Training | Change in Total Cholesterol (mg/dL) | -5.4 mg/dL |
| Aerobic Exercise+ Physical Activity | Change in Total Cholesterol (mg/dL) | -12.3 mg/dL |
Comparison: Change in total cholesterol (mg/dL)p-value: 0.067ANCOVA
Comparison: Change in total cholesterol (mg/dL) between the CON and AERO groupsp-value: 0.254ANCOVA
Comparison: Change in total cholesterol (mg/dL) between AERO and AERO-PA groupsp-value: 0.501ANCOVA
Secondary
Change in Triglyceride Level
Change in triglycerides will be measured from a blood sample at baseline and 24 weeks
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Change in Triglyceride Level | -1.6 mg/dL |
| Aerobic Exercise Training | Change in Triglyceride Level | 9.6 mg/dL |
| Aerobic Exercise+ Physical Activity | Change in Triglyceride Level | -11.7 mg/dL |
Comparison: Change in triglyceride level between the AERO-PA and CON groupsp-value: 0.456ANCOVA
Comparison: Change in triglyceride level between the CON and AERO groupsp-value: 0.422ANCOVA
Comparison: Change in triglyceride level between the AERO and AERO-PA groupsp-value: 0.136ANCOVA
Secondary
Changes in Steps
Participants will wear an accelerometer for seven consecutive days, 24-hrs/day. The amount of steps will be calculated
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control | Changes in Steps | -58.4 steps per day |
| Aerobic Exercise Training | Changes in Steps | 191.3 steps per day |
| Aerobic Exercise+ Physical Activity | Changes in Steps | 2324.5 steps per day |
Comparison: Changes in steps between the CON and the AERO groupp-value: 0.648ANCOVA
Comparison: Changes in steps between the CON group and the AERO-PA groupp-value: <0.001ANCOVA
Comparison: Changes in steps between the AERO and AERO-PA groupsp-value: <0.001ANCOVA