Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study
- Conditions
- Obesity, MorbidBariatric Surgery
- Interventions
- Behavioral: The Take a STAND for health
- Registration Number
- NCT04517591
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in post-bariatric patients. To this aim, we will conduct a crossover trial and a randomized controlled trial. The crossover trial aims to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition. The 4-month parallel-group randomized controlled trials aim to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light- (or very light-) intensity physical activity in these patients. A multitude of gold-standard techniques will be applied to evaluate the effects of the intervention on several outcomes, including sedentary time (primary outcome), physical activity levels, clinical parameters specific to each condition, cardiometabolic risk factors, immune function, and health-related quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Women aged 20 to 50 years with BMI ≥ 35 kg / m2 and associated comorbidities, or BMI ≥ 40 kg / m2 who are about to undergo Roux-en-Y gastric bypass surgery at the Metabolic and Bariatric Surgery Unit of the Faculty of Medicine.
Exclusion criteria will involve sedentary time (sitting / reclining) <8 hours per day; anemia; hypothyroidism; current malignancy or history of cancer within the past 5 years; cardiovascular disease; neurological disorders; any physical disabilities that could hamper physical testing; and being physically active (i.e., participation in ≥ 150 minutes per week of moderate-to-vigorous physical activity in bouts of ≥ 10 minutes, or ≥ 75 minutes per week of vigorous-intensity physical activity).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Take a STAND for health The Take a STAND for health A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity
- Primary Outcome Measures
Name Time Method Change from baseline to follow-up on sedentary behaviour 4 months Sedentary behaviour will be assessed by ActivPAL™
- Secondary Outcome Measures
Name Time Method Change from baseline to follow-up on quality of life 4 months Quality of life will be assessed by Bariatric Analysis and Reporting Outcome questionnaire
Change from baseline to follow-up on food intake 4 months Food intake will be assessed by means of three 24-hours food recalls
Change from baseline to follow-up on physical activity levels 4 months Physical activity levels will be assessed by ActiGraph GT3X®
Change from baseline to follow-up on aerobic capacity 4 months Aerobic capacity will be assessed by a maximal cardiopulmonary exercise test
Change from baseline to follow-up on autonomic function 4 months Autonomic function will be assessed by heart rate variability
Change from baseline to follow-up on body composition 4 months Lean mass, fat mass and bone mass will be assessed by densitometry (DEXA)
Change from baseline to follow-up on cardiovascular risk score 4 months Cardiovascular risk score will be assessed by Framingham score
Change from baseline to follow-up on sleep apnea 4 months Sleep apnea will be assessed by polysomnography
Change from baseline to follow-up on office and ambulatory blood pressure 4 months (RCT) and 5 hours (crossover) Office and ambulatory blood pressure will be assessed by automated devices
Change from baseline to follow-up on functional capacity and fatigue 4 months Functional capacity will be assessed by Timed Up-And-Go, Time-Stands and handgrip tests. Fatigue will be assessed by fatigue severity scale and Chalder fatigue scale.
Change from baseline to follow-up on cardiovascular and respiratory chemoreflex control 4 months Cardiovascular and respiratory chemoreflex control will be assessed by hyperoxia and hypoxia protocol