Clinical trial NCT02010060: Aerobic Training and Non-Exercise Physical Activity
Official title: The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Obesity
Obesity
Keywords: Exercise training
Non-exercise physical activity
pedometers
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Waist Circumference
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change in Body Fat
timeFrame: Baseline to 24 weeks
measure: Change in Body Weight
timeFrame: Baseline and 24 weeks
measure: Change in Cardiorespiratory Fitness (L/Min)
timeFrame: Baseline and 24 weeks
measure: Change in Insulin Sensitivity
timeFrame: Baseline and 24 Weeks
measure: Change in Low Density Lipoprotein (LDL)
timeFrame: Baseline and 24 weeks
measure: Change in High Density Lipoprotein (HDL)
timeFrame: Baseline and 24 Weeks
measure: Change in Total Cholesterol (mg/dL)
timeFrame: Baseline and 24 weeks
measure: Change in Triglyceride Level
timeFrame: Baseline and 24 Weeks
measure: Change in Glucose
timeFrame: Baseline and 24 weeks
measure: Change in C-reactive Protein
timeFrame: Baseline and 24 weeks
measure: Changes in Steps
timeFrame: Baseline and 24 Weeks
measure: Change in Caloric Intake (Kilocalories)
timeFrame: Baseline and 24 weeks
measure: Change in Insulin
timeFrame: Baseline and 24 Weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Damon L Swift, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.