Overview

This trial is active, not recruiting.

Conditions central obesity, obesity
Treatments aerobic exercise training, aerobic exercise+ physical activity
Sponsor East Carolina University
Start date February 2014
End date June 2017
Trial size 45 participants
Trial identifier NCT02010060, 13SDG17140091

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
(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
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
(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
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

Primary Outcomes

Measure
Change in waist circumference
time frame: Baseline, 12 weeks, 24 weeks

Secondary Outcomes

Measure
Change in body composition
time frame: Baseline and 24 weeks
Change in body weight
time frame: Baseline, 12 weeks and 24 weeks
Change in cardiorespiratory fitness
time frame: Baseline and 24 weeks
Change in oral glucose tolerance (OGTT)
time frame: Baseline and 24 Weeks
Changes in physical activity levels
time frame: Baseline, 12 weeks and 24 Weeks
Change in dietary composition
time frame: Baseline and 24 weeks
Changes in blood lipids
time frame: Baseline and 24 weeks
Change in systemic inflammation
time frame: Baseline and 24 weeks
Change in oral glucose tolerance: Glucose and insulin AUC
time frame: Baseline and 24 Weeks

Eligibility Criteria

Male or female participants from 40 years up to 65 years old.

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

Additional Information

Official title The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN)
Principal investigator Damon L Swift, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by East Carolina University.