Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Sedentary Time in Post-bariatric Patients: The Take a STAND for Health Study

Conditions
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Obesity, Morbid, Bariatric Surgery

Intervention / Treatment
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* Behavioral: The Take a STAND for health


Participation Criteria
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Eligibility Criteria
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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). -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Take a STAND for health<br>A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity | Behavioral: The Take a STAND for health<br>* A 4-month parallel-group randomised controlled trial will be performed, in which patients post-bariatric surgery will be assessed at baseline pre-surgery (PRE-BAR), 3 months after surgery and pre-intervention (PRE-INT) and 4 months after intervention (POST). Moreover, a sub-sample of patients will perform a randomised crossover trial at baseline (PRE). Patients will complete three experimental sessions in a random manner, as follows: Prolonged sitting (SIT), in which participants engaged in prolonged sitting throughout an 5-h period and were instructed to minimize excessive movement; Exercise followed by prolonged sitting (EX), in which participants performed a 30-min moderate-to-vigorous exercise bout on a treadmill, subsequently, participants engaged in prolonged sitting as described for SIT; Light-intensity breaks (BR), in which participants completed a 3-min bout of light-intensity walking every 30 min of sitting throughout the experimental period.<br>|
| No Intervention: Control<br>The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels and health nutrition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to follow-up on sedentary behaviour | Sedentary behaviour will be assessed by ActivPAL™ | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to follow-up on physical activity levels | Physical activity levels will be assessed by ActiGraph GT3X® | 4 months | 
| Change from baseline to follow-up on body composition | Lean mass, fat mass and bone mass will be assessed by densitometry (DEXA) | 4 months | 
| Change from baseline to follow-up on aerobic capacity | Aerobic capacity will be assessed by a maximal cardiopulmonary exercise test | 4 months | 
| Change from baseline to follow-up on food intake | Food intake will be assessed by means of three 24-hours food recalls | 4 months | 
| Change from baseline to follow-up on office and ambulatory blood pressure | Office and ambulatory blood pressure will be assessed by automated devices | 4 months (RCT) and 5 hours (crossover) | 
| Change from baseline to follow-up on quality of life | Quality of life will be assessed by Bariatric Analysis and Reporting Outcome questionnaire | 4 months | 
| Change from baseline to follow-up on functional capacity and fatigue | 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. | 4 months | 
| Change from baseline to follow-up on cardiovascular risk score | Cardiovascular risk score will be assessed by Framingham score | 4 months | 
| Change from baseline to follow-up on sleep apnea | Sleep apnea will be assessed by polysomnography | 4 months | 
| Change from baseline to follow-up on autonomic function | Autonomic function will be assessed by heart rate variability | 4 months | 
| Change from baseline to follow-up on cardiovascular and respiratory chemoreflex control | Cardiovascular and respiratory chemoreflex control will be assessed by hyperoxia and hypoxia protocol | 4 months |