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

University of Sao Paulo60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity, Morbid Bariatric Surgery

Interventions

The Take a STAND for healthBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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). \-

Outcomes

Primary Outcomes

Change from baseline to follow-up on sedentary behaviour

Sedentary behaviour will be assessed by ActivPAL™

Time frame: 4 months

Secondary Outcomes

Change from baseline to follow-up on physical activity levels

Physical activity levels will be assessed by ActiGraph GT3X®

Time frame: 4 months

Change from baseline to follow-up on body composition

Lean mass, fat mass and bone mass will be assessed by densitometry (DEXA)

Time frame: 4 months

Change from baseline to follow-up on aerobic capacity

Aerobic capacity will be assessed by a maximal cardiopulmonary exercise test

Time frame: 4 months

Change from baseline to follow-up on food intake

Food intake will be assessed by means of three 24-hours food recalls

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 4 months

Change from baseline to follow-up on cardiovascular risk score

Cardiovascular risk score will be assessed by Framingham score

Time frame: 4 months

Change from baseline to follow-up on sleep apnea

Sleep apnea will be assessed by polysomnography

Time frame: 4 months

Change from baseline to follow-up on autonomic function

Autonomic function will be assessed by heart rate variability

Time frame: 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

Time frame: 4 months

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts