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

NCT02693132 | Completed Results

• 1 other identifier: PRO15110570
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Exercise

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in Cardiorespiratory Fitness

  Baseline (0 weeks),12 Weeks

• Change in Body Weight

  Baseline (0 weeks),12 Weeks

• Change in Fat Mass

  Baseline (0 weeks),12 Weeks

• Change in Energy Intake

  Baseline (0 weeks),12 Weeks

Study Arms (3)

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.

Behavioral: Supervised (SUP-PA)

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.

Behavioral: Unsupervised (UNSUP-PA)

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.

Behavioral: Step-based (STEP)

Interventions

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.

Supervised (SUP-PA)

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.

Unsupervised (UNSUP-PA)

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.

Step-based (STEP)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Physical Activity and Weight Management Research Center

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Seth Creasy
• Organization: University of Colorado Denver

seth.creasy@ucdenver.edu

720-848-6477

Study Officials

• Seth A Creasy

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• John M Jakicic

  University of Pittsburgh

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 29, 2018
• Results First Posted: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)