Aerobic Training and Non-Exercise Physical Activity
Condition: Central Obesity; Obesity
MeSH terms: Obesity; Obesity, Abdominal
Study type: Interventional

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.
    

Intervention name(s): Aerobic Exercise Training; Aerobic Exercise+ Physical Activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise training; Non-exercise physical activity; pedometers