Comparison of Supervised and Unsupervised Physical Activity Programs During a Weight Loss Intervention for Adults
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

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.
    

Intervention name(s): Supervised (SUP-PA); Unsupervised (UNSUP-PA); Step-based (STEP)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Exercise