Clinical trial NCT04517591: Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study
Official title: Reducing Sedentary Time in Post-bariatric Patients: The Take a STAND for Health Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Morbid
Bariatric Surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria: 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: 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).

-

Primary outcomes:
measure: Change from baseline to follow-up on sedentary behaviour
timeFrame: 4 months
Secondary outcomes:
measure: Change from baseline to follow-up on physical activity levels
timeFrame: 4 months
measure: Change from baseline to follow-up on body composition
timeFrame: 4 months
measure: Change from baseline to follow-up on aerobic capacity
timeFrame: 4 months
measure: Change from baseline to follow-up on food intake
timeFrame: 4 months
measure: Change from baseline to follow-up on office and ambulatory blood pressure
timeFrame: 4 months (RCT) and 5 hours (crossover)
measure: Change from baseline to follow-up on quality of life
timeFrame: 4 months
measure: Change from baseline to follow-up on functional capacity and fatigue
timeFrame: 4 months
measure: Change from baseline to follow-up on cardiovascular risk score
timeFrame: 4 months
measure: Change from baseline to follow-up on sleep apnea
timeFrame: 4 months
measure: Change from baseline to follow-up on autonomic function
timeFrame: 4 months
measure: Change from baseline to follow-up on cardiovascular and respiratory chemoreflex control
timeFrame: 4 months
Other outcomes:
measure: Change from baseline to follow-up on vascular function
timeFrame: 4 months (RCT) and 5 hours (crossover)
measure: Change from baseline to follow-up on blood markers
timeFrame: 4 months (RCT) and 5 hours (crossover)
measure: Change from baseline to follow-up on inflammatory markers
timeFrame: 4 months
measure: Change from baseline to follow-up on oral glucose tolerance test
timeFrame: 4 months
measure: Protein expression
timeFrame: 4 months (RCT) and 5 hours (crossover)
measure: Gene expression
timeFrame: 4 months (RCT) and 5 hours (crossover)
Locations:
Study officials:
References: