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Completed

NCT Number: NCT02010060

Aerobic Training and Non-Exercise Physical Activity

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.

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Key information

Conditions

Central Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University

Greenville, North Carolina, 27858, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Change in Waist Circumference

    Time frame: 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 outcomes

  1. Change in Body Fat

    Time frame: Baseline to 24 weeks

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

  2. Change in Body Weight

    Time frame: Baseline and 24 weeks

    Weight will be measured using a standardized scale

  3. Change in Cardiorespiratory Fitness (L/Min)

    Time frame: 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).

  4. Change in Insulin Sensitivity

    Time frame: 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.

  5. Change in Low Density Lipoprotein (LDL)

    Time frame: Baseline and 24 weeks

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

  6. Change in High Density Lipoprotein (HDL)

    Time frame: Baseline and 24 Weeks

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

  7. Change in Total Cholesterol (mg/dL)

    Time frame: Baseline and 24 weeks

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

  8. Change in Triglyceride Level

    Time frame: Baseline and 24 Weeks

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

  9. Change in Glucose

    Time frame: Baseline and 24 weeks

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

  10. Change in C-reactive Protein

    Time frame: Baseline and 24 weeks

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

  11. Changes in Steps

    Time frame: Baseline and 24 Weeks

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

  12. Change in Caloric Intake (Kilocalories)

    Time frame: 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.

  13. Change in Insulin

    Time frame: Baseline and 24 Weeks

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

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Official study title

The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN)

Acronym: I-CAN

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 12, 2013
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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