N/A
Completed N=45
Aerobic Training and Non-Exercise Physical Activity
Central Obesity · Obesity
Source: ClinicalTrials.gov NCT02010060 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Change in Waist Circumference — -1.3; -1.9; -4.1 cm — p=0.074
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Waist Circumference |
-1.3; -1.9; -4.1 | 0.074 |
| SECONDARY Change in Body Fat |
0.071; -0.71; -1.35 | 0.011 sig |
| SECONDARY Change in Body Weight |
-0.44; -1.11; -2.38 | 0.104 |
| SECONDARY Change in Cardiorespiratory Fitness (L/Min) |
0.01; 0.094; 0.28 | 0.002 sig |
| SECONDARY Change in Insulin Sensitivity |
0.84; 0.25; 0.75 | 0.891 |
| SECONDARY Change in Low Density Lipoprotein (LDL) |
2.2; -5.2; -8.7 | 0.274 |
| SECONDARY Change in High Density Lipoprotein (HDL) |
-1.9; -2.2; -1.4 | 0.837 |
| SECONDARY Change in Total Cholesterol (mg/dL) |
6.1; -5.4; -12.3 | 0.067 |
| SECONDARY Change in Triglyceride Level |
-1.6; 9.6; -11.7 | 0.456 |
| SECONDARY Change in Glucose |
1.0; -1.6; -0.62 | 0.483 |
| SECONDARY Change in C-reactive Protein |
0.83; 0.51; 0.34 | 0.489 |
| SECONDARY Changes in Steps |
-58.4; 191.3; 2324.5 | <0.001 sig |
| SECONDARY Change in Caloric Intake (Kilocalories) |
-553.2; -264.3; -276.9 | 0.226 |
| SECONDARY Change in Insulin |
-3.7; -3.2; -1.9 | 0.337 |
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
Data sourced from ClinicalTrials.gov (NCT02010060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.