AzTrials
AzTrials

ObesityREACHNCT02693132

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

A study testing Supervised (SUP-PA), Unsupervised (UNSUP-PA) and Step-based (STEP) in people with Obesity, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Supervised (SUP-PA), Unsupervised (UNSUP-PA) and Step-based (STEP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
Feb 2016to Aug 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Physical Activity and Weight Management Research Center

    Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Obesity
Being tested
Supervised (SUP-PA), Unsupervised (UNSUP-PA), Step-based (STEP)
Keywords
Obesity, Exercise
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised (SUP-PA)Behavioural

    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.

  • Unsupervised (UNSUP-PA)Behavioural

    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)Behavioural

    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.

Study groups in NCT02693132
Study groupRoleWhat they receive
Supervised (SUP-PA)ExperimentalWeight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.
Receives: Behavioral: Supervised (SUP-PA)
Unsupervised (UNSUP-PA)ExperimentalWeight 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.
Receives: Behavioral: Unsupervised (UNSUP-PA)
Step-based (STEP)ExperimentalWeight 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.
Receives: Behavioral: Step-based (STEP)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured using a wearable device and by questionnaire

    Measured: Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks

Secondary outcomes (4)
  1. 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.

    Measured: Baseline (0 weeks),12 Weeks

  2. Change in Body Weight

    Measured in kilograms using a digital scale

    Measured: Baseline (0 weeks),12 Weeks

  3. Change in Fat Mass

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

    Measured: Baseline (0 weeks),12 Weeks

  4. Change in Energy Intake

    Measured as kcal/day using a questionnaire

    Measured: Baseline (0 weeks),12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02693132
Sponsor's protocol ID
PRO15110570
Acronym
REACH
Status last verified
Nov 2018
First submitted
23 Feb 2016
Last updated
29 Nov 2018
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Supervised (SUP-PA), Unsupervised (UNSUP-PA) and Step-based (STEP) in people with Obesity, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes) (time frame: Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in