Trial Outcomes & Findings for Aerobic Training and Non-Exercise Physical Activity (NCT NCT02010060)

NCT ID: NCT02010060

Last Updated: 2024-10-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

Baseline and 24 weeks

Results posted on

2024-10-31

Participant Flow

Participants were recruited from the local Greenville, NC area. Participants were recruited through flyers, the local newspaper, and email list in the Greenville area.

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.

Participant milestones

Participant milestones
Measure	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.	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	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
Overall Study STARTED	15	15	15
Overall Study COMPLETED	14	12	13
Overall Study NOT COMPLETED	1	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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	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
Overall Study Lost to Follow-up	1	2	2
Overall Study Injury	0	1	0

Baseline Characteristics

Aerobic Training and Non-Exercise Physical Activity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=15 Participants 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 n=15 Participants 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	Aerobic Exercise+ Physical Activity n=15 Participants 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	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	45 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	54.1 years STANDARD_DEVIATION 7.5 • n=5 Participants	49.7 years STANDARD_DEVIATION 6.5 • n=7 Participants	54.1 years STANDARD_DEVIATION 8.3 • n=5 Participants	52.6 years STANDARD_DEVIATION 7.6 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	31 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	15 participants n=5 Participants	45 participants n=4 Participants
Weight	98.6 kg STANDARD_DEVIATION 12.8 • n=5 Participants	102.9 kg STANDARD_DEVIATION 19.8 • n=7 Participants	97.6 kg STANDARD_DEVIATION 8.6 • n=5 Participants	99.7 kg STANDARD_DEVIATION 14.4 • n=4 Participants
Body mass index	35.3 kg/m^2 STANDARD_DEVIATION 3.8 • n=5 Participants	36.6 kg/m^2 STANDARD_DEVIATION 5.7 • n=7 Participants	36.2 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants	36.0 kg/m^2 STANDARD_DEVIATION 4.8 • n=4 Participants
Body fat percentage	44.7 Percent STANDARD_DEVIATION 4.7 • n=5 Participants	46.1 Percent STANDARD_DEVIATION 5.2 • n=7 Participants	46.2 Percent STANDARD_DEVIATION 6.0 • n=5 Participants	45.7 Percent STANDARD_DEVIATION 5.2 • n=4 Participants
Waist circumference	106.8 cm STANDARD_DEVIATION 8.5 • n=5 Participants	105.2 cm STANDARD_DEVIATION 10.5 • n=7 Participants	103.6 cm STANDARD_DEVIATION 6.7 • n=5 Participants	105.2 cm STANDARD_DEVIATION 8.6 • n=4 Participants
Absolute fitness	2.0 L/min STANDARD_DEVIATION 0.5 • n=5 Participants	2.1 L/min STANDARD_DEVIATION 0.6 • n=7 Participants	2.0 L/min STANDARD_DEVIATION 5.0 • n=5 Participants	2.0 L/min STANDARD_DEVIATION 5.0 • n=4 Participants
Relative Fitness	20.0 mL/kg/min STANDARD_DEVIATION 4.6 • n=5 Participants	20.3 mL/kg/min STANDARD_DEVIATION 3.5 • n=7 Participants	20.4 mL/kg/min STANDARD_DEVIATION 3.0 • n=5 Participants	20.2 mL/kg/min STANDARD_DEVIATION 3.7 • n=4 Participants
Glucose	96.4 mg/dL STANDARD_DEVIATION 4.5 • n=5 Participants	97.0 mg/dL STANDARD_DEVIATION 6.8 • n=7 Participants	96.3 mg/dL STANDARD_DEVIATION 7.3 • n=5 Participants	96.6 mg/dL STANDARD_DEVIATION 6.2 • n=4 Participants
Insulin	17.1 μU·mL-1 STANDARD_DEVIATION 7.7 • n=5 Participants	14.4 μU·mL-1 STANDARD_DEVIATION 5.8 • n=7 Participants	17.1 μU·mL-1 STANDARD_DEVIATION 5.8 • n=5 Participants	16.2 μU·mL-1 STANDARD_DEVIATION 6.5 • n=4 Participants
Very low density lipoprotein	29.5 mg/dL STANDARD_DEVIATION 12.8 • n=5 Participants	23.6 mg/dL STANDARD_DEVIATION 11.8 • n=7 Participants	22.5 mg/dL STANDARD_DEVIATION 9.7 • n=5 Participants	25.2 mg/dL STANDARD_DEVIATION 11.7 • n=4 Participants
Total Cholesterol	189.0 mg/dL STANDARD_DEVIATION 25.8 • n=5 Participants	204.0 mg/dL STANDARD_DEVIATION 25.5 • n=7 Participants	208.1 mg/dL STANDARD_DEVIATION 30.7 • n=5 Participants	200.4 mg/dL STANDARD_DEVIATION 28.1 • n=4 Participants
High density lipoprotein	47.3 mg/dL STANDARD_DEVIATION 11.2 • n=5 Participants	45.1 mg/dL STANDARD_DEVIATION 8.8 • n=7 Participants	58.1 mg/dL STANDARD_DEVIATION 14.9 • n=5 Participants	50.2 mg/dL STANDARD_DEVIATION 12.9 • n=4 Participants
Low density lipoprotein	112.3 mg/dL STANDARD_DEVIATION 23.9 • n=5 Participants	204.0 mg/dL STANDARD_DEVIATION 25.5 • n=7 Participants	208.1 mg/dL STANDARD_DEVIATION 30.4 • n=5 Participants	200.4 mg/dL STANDARD_DEVIATION 28.1 • n=4 Participants
Insulin Sensitivity	2.9 index STANDARD_DEVIATION 1.4 • n=5 Participants	4.9 index STANDARD_DEVIATION 3.7 • n=7 Participants	3.5 index STANDARD_DEVIATION 1.5 • n=5 Participants	3.7 index STANDARD_DEVIATION 2.5 • n=4 Participants
Triglycerides	147.7 mg/dL STANDARD_DEVIATION 63.3 • n=5 Participants	118.3 mg/dL STANDARD_DEVIATION 59.1 • n=7 Participants	112.9 mg/dL STANDARD_DEVIATION 49.4 • n=5 Participants	126.3 mg/dL STANDARD_DEVIATION 58.4 • n=4 Participants
C-reactive protein	1.8 mg/L STANDARD_DEVIATION 1.0 • n=5 Participants	4.3 mg/L STANDARD_DEVIATION 3.5 • n=7 Participants	4.0 mg/L STANDARD_DEVIATION 3.1 • n=5 Participants	3.4 mg/L STANDARD_DEVIATION 3.0 • n=4 Participants
baseline steps	4479.3 steps/day STANDARD_DEVIATION 1285.9 • n=5 Participants	4899.3 steps/day STANDARD_DEVIATION 1186.3 • n=7 Participants	4528.3 steps/day STANDARD_DEVIATION 1296.0 • n=5 Participants	4635.6 steps/day STANDARD_DEVIATION 1242.7 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Waist Circumference	-1.3 cm Interval -3.43 to 0.85	-1.9 cm Interval -4.25 to 0.39	-4.1 cm Interval -6.32 to -1.87

SECONDARY outcome

Timeframe: Baseline to 24 weeks

Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Body Fat	0.071 percent of body fat Interval -0.68 to 0.82	-0.71 percent of body fat Interval -1.53 to 0.09	-1.35 percent of body fat Interval -2.13 to -0.57

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Weight will be measured using a standardized scale

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Body Weight	-0.44 kg Interval -2.01 to 1.2	-1.11 kg Interval -2.88 to 0.66	-2.38 kg Interval -4.08 to -0.68

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Cardiorespiratory Fitness (L/Min)	0.01 Liters/minute Interval -0.11 to 0.12	0.094 Liters/minute Interval -0.04 to 0.22	0.28 Liters/minute Interval 0.16 to 0.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Insulin Sensitivity	0.84 Index Interval -0.1 to 1.78	0.25 Index Interval -0.81 to 1.3	0.75 Index Interval -0.2 to 1.7

SECONDARY outcome

Timeframe: Baseline and 24 weeks

LDL level will be measured from a blood sample at baseline and follow-up.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Low Density Lipoprotein (LDL)	2.2 mg/dL Interval -11.6 to 16.0	-5.2 mg/dL Interval -20.1 to 9.6	-8.7 mg/dL Interval -22.9 to 5.6

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

HDL cholesterol level will be measured from a blood sample at baseline and follow-up

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in High Density Lipoprotein (HDL)	-1.9 mg/dL Interval -5.1 to 1.4	-2.2 mg/dL Interval -5.6 to 1.3	-1.4 mg/dL Interval -4.7 to 2.0

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Total cholesterol will be measured by a blood sample at baseline and 24 weeks

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Total Cholesterol (mg/dL)	6.1 mg/dL Interval -7.6 to 19.9	-5.4 mg/dL Interval -20.3 to 9.4	-12.3 mg/dL Interval -26.6 to 1.9

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Change in triglycerides will be measured from a blood sample at baseline and 24 weeks

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Triglyceride Level	-1.6 mg/dL Interval -20.6 to 17.5	9.6 mg/dL Interval -10.9 to 30.2	-11.7 mg/dL Interval -31.5 to 8.0

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Glucose concentration from a fasting blood sample will be measured at baseline and follow-up

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Glucose	1.0 mg/dL Interval -2.2 to 4.2	-1.6 mg/dL Interval -5.1 to 1.9	-0.62 mg/dL Interval -3.9 to 2.7

SECONDARY outcome

Timeframe: Baseline and 24 weeks

High sensitivity c-reactive protein (inflammatory marker) will be measured at baseline and follow-up

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in C-reactive Protein	0.83 mg/L Interval -0.16 to 1.83	0.51 mg/L Interval -0.57 to 1.58	0.34 mg/L Interval -0.69 to 1.37

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Participants will wear an accelerometer for seven consecutive days, 24-hrs/day. The amount of steps will be calculated

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Changes in Steps	-58.4 steps per day Interval -805.8 to 689.1	191.3 steps per day Interval -616.1 to 998.6	2324.5 steps per day Interval 1548.9 to 3100.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Caloric Intake (Kilocalories)	-553.2 kcals Interval -874.7 to -231.6	-264.3 kcals Interval -599.0 to 70.3	-276.9 kcals Interval -589.4 to 44.6

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Insulin level will be measured from a fasting blood sample at baseline and at 24 weeks

Outcome measures

Outcome measures
Measure	Control n=14 Participants 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 n=12 Participants 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	Aerobic Exercise+ Physical Activity n=13 Participants 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
Change in Insulin	-3.7 μU·mL-1 Interval -6.3 to -1.0	-3.2 μU·mL-1 Interval -5.9 to -0.4	-1.9 μU·mL-1 Interval -4.5 to 0.7

Adverse Events

Control (CON)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aerobic Exercise Training (AERO)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aerobic Exercise+ Physical Activity (AERO-PA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Damon Swift

University of Virginia

Phone: (434) 924-1436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place