Central ObesityI-CANNCT02010060
Aerobic Training and Non-Exercise Physical Activity
A study testing Aerobic Exercise Training and Aerobic Exercise+ Physical Activity in people with Central Obesity and Obesity, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Central Obesity, Obesity
- What is being tested?
- Aerobic Exercise Training and Aerobic Exercise+ Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40 to 65 years
- Body mass index: 30-40
- Sedentary status
- One additional risk factor for cardiovascular disease
- High waist circumference
Who cannot join
- 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
Show all 9Show fewer
- Not full-filling requirements during the screening process
- Currently using weight loss medications
- Gastric banding surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27858
About this study
Official title: The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN)
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.
Read the 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.
- Conditions
- Central Obesity, Obesity
- Being tested
- Aerobic Exercise Training, Aerobic Exercise+ Physical Activity
- Keywords
- Exercise training, Non-exercise physical activity, pedometers
- Medical subject headings
- Obesity, Abdominal, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingBehavioural
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 ActivityBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 | Experimental | 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 Receives: Behavioral: Aerobic Exercise Training |
| Aerobic Exercise+ Physical Activity | Experimental | 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 Receives: Behavioral: Aerobic Exercise+ Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 weeks
Secondary outcomes (13)
Change in Body Fat
Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass.
Measured: Baseline to 24 weeks
Change in Body Weight
Weight will be measured using a standardized scale
Measured: Baseline and 24 weeks
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).
Measured: Baseline and 24 weeks
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.
Measured: Baseline and 24 Weeks
Change in Low Density Lipoprotein (LDL)
LDL level will be measured from a blood sample at baseline and follow-up.
Measured: Baseline and 24 weeks
Change in High Density Lipoprotein (HDL)
HDL cholesterol level will be measured from a blood sample at baseline and follow-up
Measured: Baseline and 24 Weeks
Change in Total Cholesterol (mg/dL)
Total cholesterol will be measured by a blood sample at baseline and 24 weeks
Measured: Baseline and 24 weeks
Change in Triglyceride Level
Change in triglycerides will be measured from a blood sample at baseline and 24 weeks
Measured: Baseline and 24 Weeks
Change in Glucose
Glucose concentration from a fasting blood sample will be measured at baseline and follow-up
Measured: Baseline and 24 weeks
Change in C-reactive Protein
High sensitivity c-reactive protein (inflammatory marker) will be measured at baseline and follow-up
Measured: Baseline and 24 weeks
Changes in Steps
Participants will wear an accelerometer for seven consecutive days, 24-hrs/day. The amount of steps will be calculated
Measured: Baseline and 24 Weeks
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.
Measured: Baseline and 24 weeks
Change in Insulin
Insulin level will be measured from a fasting blood sample at baseline and at 24 weeks
Measured: Baseline and 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damon Swift, East Carolina University
- Investigators
- Damon L Swift, Ph.D., Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010060
- Sponsor's protocol ID
- 13SDG17140091
- Acronym
- I-CAN
- Status last verified
- Aug 2024
- First submitted
- 5 Dec 2013
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26542389Swift 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.
PubMed 33867498
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN)
- ClinicalTrials.gov ID
- NCT02010060
- Acronym / sponsor ID
- I-CAN / 13SDG17140091
- Conditions
- Central Obesity, Obesity
- Keywords
- Exercise training, Non-exercise physical activity, pedometers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 | Experimental | Behavioral: Aerobic Exercise TrainingThe 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+ Physical Activity | Experimental | Behavioral: Aerobic Exercise+ Physical ActivityThe 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 40 to 65 years
- Body mass index: 30-40
- Sedentary status
- One additional risk factor for cardiovascular disease
- High waist circumference
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise TrainingIndividuals 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 | Behavioural | Aerobic Exercise Training |
| Aerobic Exercise+ Physical ActivityThe 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 | Behavioural | Aerobic Exercise+ Physical Activity |
Primary outcome
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.
13 secondary outcomes
Change in Body Fat
Time frame: Baseline to 24 weeks
Change in Body Weight
Time frame: Baseline and 24 weeks
Change in Cardiorespiratory Fitness (L/Min)
Time frame: Baseline and 24 weeks
Change in Insulin Sensitivity
Time frame: Baseline and 24 Weeks
Change in Low Density Lipoprotein (LDL)
Time frame: Baseline and 24 weeks
Change in High Density Lipoprotein (HDL)
Time frame: Baseline and 24 Weeks
Change in Total Cholesterol (mg/dL)
Time frame: Baseline and 24 weeks
Change in Triglyceride Level
Time frame: Baseline and 24 Weeks
Change in Glucose
Time frame: Baseline and 24 weeks
Change in C-reactive Protein
Time frame: Baseline and 24 weeks
Changes in Steps
Time frame: Baseline and 24 Weeks
Change in Caloric Intake (Kilocalories)
Time frame: Baseline and 24 weeks
Change in Insulin
Time frame: Baseline and 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26542389Swift 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.
- Derived from this study: PubMed 33867498Swift 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damon L Swift, Ph.D. principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training and Aerobic Exercise+ Physical Activity in people with Central Obesity and Obesity, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Waist Circumference (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02010060, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.