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Comparison of Supervised and Unsupervised Physical Activity Programs During a Weight Loss Intervention for Adults

Comparison of Supervised and Unsupervised Physical Activity Programs During a Standard Behavioral Weight Loss Intervention for Adults Who Are Overweight or Obese

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02693132
Acronym
REACH
Enrollment
52
Registered
2016-02-26
Start date
2016-02-29
Completion date
2016-08-31
Last updated
2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Exercise

Brief 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.

Detailed description

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.

Interventions

BEHAVIORALSupervised (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.

BEHAVIORALUnsupervised (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.

BEHAVIORALStep-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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or Female * Aged 18-55 years old * BMI of 25.0 to \<40.0 kg/m2 * Ability to provide informed consent * Ability to provide physician's clearance to participate in a weight loss intervention

Exclusion criteria

* Engaging in \>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.)

Design outcomes

Primary

MeasureTime frameDescription
Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 WeeksMeasured using a wearable device and by questionnaire

Secondary

MeasureTime frameDescription
Change in Cardiorespiratory FitnessBaseline (0 weeks),12 WeeksMeasured 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.
Change in Body WeightBaseline (0 weeks),12 WeeksMeasured in kilograms using a digital scale
Change in Fat MassBaseline (0 weeks),12 WeeksMeasured as fat mass (kg) using dual-energy x-ray absorptiometry (DXA)
Change in Energy IntakeBaseline (0 weeks),12 WeeksMeasured as kcal/day using a questionnaire

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
17
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.
17
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.
18
Total52

Baseline characteristics

CharacteristicSupervised (SUP-PA)TotalStep-based (STEP)Unsupervised (UNSUP-PA)
Age, Continuous45.2 years
STANDARD_DEVIATION 8.5
43.5 years
STANDARD_DEVIATION 10.1
39.3 years
STANDARD_DEVIATION 10.7
46.2 years
STANDARD_DEVIATION 10.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants5 Participants3 Participants1 Participants
Race (NIH/OMB)
Black or African American
4 Participants12 Participants3 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
12 Participants35 Participants12 Participants11 Participants
Region of Enrollment
United States
17 Participants52 Participants18 Participants17 Participants
Sex: Female, Male
Female
13 Participants38 Participants13 Participants12 Participants
Sex: Female, Male
Male
4 Participants14 Participants5 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 170 / 170 / 18
other
Total, other adverse events
0 / 170 / 170 / 18
serious
Total, serious adverse events
0 / 170 / 170 / 18

Outcome results

Primary

Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)

Measured using a wearable device and by questionnaire

Time frame: Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Supervised (SUP-PA)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)Baseline28.0 minutes/dayStandard Deviation 23.5
Supervised (SUP-PA)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)4 Weeks44.4 minutes/dayStandard Deviation 24
Supervised (SUP-PA)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)8 Weeks54.3 minutes/dayStandard Deviation 37.2
Supervised (SUP-PA)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)12 Weeks49.6 minutes/dayStandard Deviation 38.7
Unsupervised (UNSUP-PA)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)12 Weeks41.7 minutes/dayStandard Deviation 44.5
Unsupervised (UNSUP-PA)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)Baseline25.6 minutes/dayStandard Deviation 36
Unsupervised (UNSUP-PA)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)8 Weeks46.1 minutes/dayStandard Deviation 45.5
Unsupervised (UNSUP-PA)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)4 Weeks38.3 minutes/dayStandard Deviation 42.6
Step-based (STEP)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)12 Weeks47.0 minutes/dayStandard Deviation 28.2
Step-based (STEP)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)4 Weeks42.8 minutes/dayStandard Deviation 23.6
Step-based (STEP)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)8 Weeks51.2 minutes/dayStandard Deviation 33.5
Step-based (STEP)Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)Baseline35.4 minutes/dayStandard Deviation 33.5
p-value: <0.05ANOVA
Secondary

Change in Body Weight

Measured in kilograms using a digital scale

Time frame: Baseline (0 weeks),12 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Supervised (SUP-PA)Change in Body WeightBaseline84.0 kilogramsStandard Deviation 13.7
Supervised (SUP-PA)Change in Body Weight12 Weeks80.1 kilogramsStandard Deviation 13.2
Unsupervised (UNSUP-PA)Change in Body WeightBaseline86.8 kilogramsStandard Deviation 13.1
Unsupervised (UNSUP-PA)Change in Body Weight12 Weeks81.6 kilogramsStandard Deviation 11.8
Step-based (STEP)Change in Body WeightBaseline87.7 kilogramsStandard Deviation 14.7
Step-based (STEP)Change in Body Weight12 Weeks82.3 kilogramsStandard Deviation 14.1
p-value: <0.05ANOVA
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.

Time frame: Baseline (0 weeks),12 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Supervised (SUP-PA)Change in Cardiorespiratory Fitness12 Weeks28.2 ml/kg/minStandard Deviation 4.9
Supervised (SUP-PA)Change in Cardiorespiratory FitnessBaseline24.4 ml/kg/minStandard Deviation 4.2
Unsupervised (UNSUP-PA)Change in Cardiorespiratory Fitness12 Weeks27.7 ml/kg/minStandard Deviation 5.7
Unsupervised (UNSUP-PA)Change in Cardiorespiratory FitnessBaseline23.9 ml/kg/minStandard Deviation 4.5
Step-based (STEP)Change in Cardiorespiratory Fitness12 Weeks29.2 ml/kg/minStandard Deviation 6
Step-based (STEP)Change in Cardiorespiratory FitnessBaseline27.9 ml/kg/minStandard Deviation 5.5
p-value: <0.05ANOVA
Secondary

Change in Energy Intake

Measured as kcal/day using a questionnaire

Time frame: Baseline (0 weeks),12 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Supervised (SUP-PA)Change in Energy IntakeBaseline1774 kcal/dayStandard Deviation 679
Supervised (SUP-PA)Change in Energy Intake12 Weeks1214 kcal/dayStandard Deviation 370
Unsupervised (UNSUP-PA)Change in Energy IntakeBaseline1773 kcal/dayStandard Deviation 922
Unsupervised (UNSUP-PA)Change in Energy Intake12 Weeks1342 kcal/dayStandard Deviation 438
Step-based (STEP)Change in Energy IntakeBaseline1885 kcal/dayStandard Deviation 905
Step-based (STEP)Change in Energy Intake12 Weeks1497 kcal/dayStandard Deviation 522
p-value: <0.05ANOVA
Secondary

Change in Fat Mass

Measured as fat mass (kg) using dual-energy x-ray absorptiometry (DXA)

Time frame: Baseline (0 weeks),12 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Supervised (SUP-PA)Change in Fat MassBaseline34.6 kilogramsStandard Deviation 6.7
Supervised (SUP-PA)Change in Fat Mass12 Weeks30.8 kilogramsStandard Deviation 6.4
Unsupervised (UNSUP-PA)Change in Fat MassBaseline35.4 kilogramsStandard Deviation 7.6
Unsupervised (UNSUP-PA)Change in Fat Mass12 Weeks31.3 kilogramsStandard Deviation 8.2
Step-based (STEP)Change in Fat MassBaseline33.7 kilogramsStandard Deviation 6.3
Step-based (STEP)Change in Fat Mass12 Weeks29.6 kilogramsStandard Deviation 6.2
p-value: <0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026