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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.
Approximately 69% of the U.S. adult population is overweight, defined by a body mass index (BMI) of ≥ 25.0 kg/m2, and 35% are obese (BMI ≥ 30.0 kg/m2), with the prevalence of overweight and obesity rising drastically over the past several decades. Adults who are overweight or obese are typically recommended to change lifestyle factors (e.g. diet, physical activity, etc.) to lose weight and improve health. When evaluating the effects of these lifestyle changes on weight and health in a research setting, physical activity is supervised (i.e. physical activity completed in a health-fitness facility with direct supervision from trained staff). With supervised physical activity, researchers are able to quantify the frequency, intensity, duration, and type of physical activity. Thus, supervised physical activity is considered the gold-standard when evaluating the effects of physical activity on weight and other physiological parameters. However, the results of supervised physical activity trials may not translate to clinical settings. A typical clinical approach prescribes physical activity in an unsupervised manner (i.e. physician tells patient to be more physically active or take more steps/day). Unsupervised physical 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 especially in an overweight and obese population. 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.
Participants will be randomized to one of three groups: supervised physical activity prescribed in min/week (SUP-PA), unsupervised physical activity prescribed in min/week (UNSUP-PA), and unsupervised physical activity prescribed in steps/day (STEP). Participants in all three groups will participate in a behavioral weight loss intervention which includes dietary counseling and weekly group sessions during the 12-week program. SUP-PA will be prescribed 150 minutes/week of moderate-to-vigorous physical activity (MVPA) completed under direct supervision of trained staff at a designated health-fitness facility. UNSUP-PA will be prescribed a physical activity dose matched to SUP-PA. STEP will be prescribed a 10,000 step/day recommendation with 2,500 of those steps completed at a "brisk" pace. The primary aim of this study is to compare the effects of all three groups on moderate-to-vigorous physical activity (MVPA) accumulated in bouts of at least 10 minutes. The primary outcome will be assessed at baseline, week 4, week 8, and week 12. Secondary aims of this trial include comparing light intensity physical activity, sedentary time, cardiorespiratory fitness, weight, body composition, waist circumference measures, physical activity self-efficacy, blood pressure, and dietary intake across all three groups. Secondary aims will be assessed at baseline and week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised (SUP-PA) | Experimental | Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff. |
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| Unsupervised (UNSUP-PA) | Experimental | Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool. |
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| Step-based (STEP) | Experimental | Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised (SUP-PA) | Behavioral | Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes) | Measured using a wearable device and by questionnaire | Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiorespiratory Fitness | Measured using a submaximal graded exercise test on a treadmill, with termination occurring at 85% of age-predicted maximal heart rate (computed at [220-age]*0.85]). The outcome was measures as oxygen consumption (ml/kg/min) at the point of test termination. | Baseline (0 weeks),12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth A Creasy | University of Pittsburgh | Principal Investigator |
| John M Jakicic | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Activity and Weight Management Research Center | Pittsburgh | Pennsylvania | 15261 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supervised (SUP-PA) | Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff. Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity. |
| FG001 | Unsupervised (UNSUP-PA) | Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool. Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity. |
| FG002 | Step-based (STEP) | Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day. Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Supervised (SUP-PA) | Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff. Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes) | Measured using a wearable device and by questionnaire | Posted | Mean | Standard Deviation | minutes/day | Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks |
|
Adverse Event Data were collected during the 3 months of the intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supervised (SUP-PA) | Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff. Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seth Creasy | University of Colorado Denver | 720-848-6477 | seth.creasy@ucdenver.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Unsupervised (UNSUP-PA) | Behavioral | Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity. |
|
| Step-based (STEP) | Behavioral | Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day. |
|
| Change in Body Weight |
Measured in kilograms using a digital scale |
| Baseline (0 weeks),12 Weeks |
| Change in Fat Mass | Measured as fat mass (kg) using dual-energy x-ray absorptiometry (DXA) | Baseline (0 weeks),12 Weeks |
| Change in Energy Intake | Measured as kcal/day using a questionnaire | Baseline (0 weeks),12 Weeks |
| BG001 | Unsupervised (UNSUP-PA) | Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool. Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity. |
| BG002 | Step-based (STEP) | Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day. Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Step-based (STEP) | Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day. Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day. |
|
|
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| Secondary | Change in Cardiorespiratory Fitness | Measured using a submaximal graded exercise test on a treadmill, with termination occurring at 85% of age-predicted maximal heart rate (computed at [220-age]*0.85]). The outcome was measures as oxygen consumption (ml/kg/min) at the point of test termination. | Posted | Mean | Standard Deviation | ml/kg/min | Baseline (0 weeks),12 Weeks |
|
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|
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| Secondary | Change in Body Weight | Measured in kilograms using a digital scale | Posted | Mean | Standard Deviation | kilograms | Baseline (0 weeks),12 Weeks |
|
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|
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| Secondary | Change in Fat Mass | Measured as fat mass (kg) using dual-energy x-ray absorptiometry (DXA) | Posted | Mean | Standard Deviation | kilograms | Baseline (0 weeks),12 Weeks |
|
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|
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| Secondary | Change in Energy Intake | Measured as kcal/day using a questionnaire | Posted | Mean | Standard Deviation | kcal/day | Baseline (0 weeks),12 Weeks |
|
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|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Unsupervised (UNSUP-PA) | Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool. Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Step-based (STEP) | Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day. Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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