N/A
N=52
Comparison of Supervised and Unsupervised Physical Activity Programs During a Weight Loss Intervention for Adults
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02693132 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes) — 28.0; 25.6; 35.4; 44.4 minutes/day — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supervised (SUP-PA) (Behavioral); Unsupervised (UNSUP-PA) (Behavioral); Step-based (STEP) (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes) |
28.0; 25.6; 35.4; 44.4; 38.3; 42.8 | <0.05 sig |
| SECONDARY Change in Cardiorespiratory Fitness |
24.4; 23.9; 27.9; 28.2; 27.7; 29.2 | <0.05 sig |
| SECONDARY Change in Body Weight |
84.0; 86.8; 87.7; 80.1; 81.6; 82.3 | <0.05 sig |
| SECONDARY Change in Fat Mass |
34.6; 35.4; 33.7; 30.8; 31.3; 29.6 | <0.05 sig |
| SECONDARY Change in Energy Intake |
1774; 1773; 1885; 1214; 1342; 1497 | <0.05 sig |
Summary
Adults who are overweight or obese are typically prescribed a calorie-restricted diet and physical activity to promote weight loss and improve health. The manner in which physical activity is prescribed and monitored may influence physical activity engagement. Within the context of clinical research, physical activity has been prescribed in either a supervised or unsupervised manner. Supervised physical activity is typically done in a health-fitness facility under the direct supervision of trained staff. The alternative, unsupervised physical activity, promotes physical activity participation in a setting that is convenient to the individual. Unsupervised activity can be done in any environment or at any time that best suits the individual. Knowing the effects of unsupervised physical activity is important because of the translation of this type of physical activity to non-research settings. Therefore, knowing the magnitude of the physiological effects of unsupervised physical activity compared to supervised physical activity at the same prescribed intensity and dose is of clinical and public health importance. This study is designed to provide insight on these important research questions that can inform future research and the application to clinical, public health, and health-fitness settings.
Eligibility Criteria
Inclusion Criteria
- Male or Female
- Aged 18-55 years old
- BMI of 25.0 to 60 min/wk (accumulated in bouts of ≥10 minutes) of moderate-to-vigorous physical activity over the past month
- Presence of contraindications to physical activity as identified on a physical activity readiness questionnaire (PAR-Q)
- History of metabolic, cardiac, or pulmonary disease that classifies the individual as high risk by the American College of Sports Medicine (e.g., coronary heart disease, diabetes mellitus, uncontrolled hypertension, etc.)
- History of myocardial infarction, coronary bypass surgery, angioplasty, or other cardiovascular- related surgeries.
- Taking medication that may affect heart rate or blood pressure responses to physical activity
- Resting systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg.
- Medication that may affect body weight/metabolism (e.g., synthroid).
- Current or previous participation in a physical activity or weight management research project in the past 6 months
- Weight loss of ≥5% or 15 pounds total of current body weight in the previous 6 months.
- Currently being treated for an eating disorder (e.g., anorexia, bulimia, etc.)
- Previously undergone bariatric surgery (e.g., lap-band, gastric bypass, etc.)
- For women, those currently pregnant, pregnant during the previous 6 months, or plan on becoming pregnant in the next 6 months
- Currently being treated for any psychological issues or problems, taking any psychotropic medications, or receiving treatment with psychotropic medications within the previous 6 months.
- Being out of town during for an extended amount of time during the weight loss intervention which may affect participation in the study
- Currently using a physical activity monitor to track activity (e.g., Jawbone UP, Fitbit, etc.)
Data sourced from ClinicalTrials.gov (NCT02693132). 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.