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

Primary Purpose

Obesity, Morbid, Bariatric Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Take a STAND for health
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

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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).

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Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Take a STAND for health

    Control

    Arm Description

    A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity

    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.

    Outcomes

    Primary Outcome Measures

    Change from baseline to follow-up on sedentary behaviour
    Sedentary behaviour will be assessed by ActivPAL™

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 12, 2020
    Last Updated
    August 13, 2020
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04517591
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 7, 2020 (Anticipated)
    Primary Completion Date
    October 8, 2022 (Anticipated)
    Study Completion Date
    October 8, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Morbid, Bariatric Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Take a STAND for health
    Arm Type
    Experimental
    Arm Description
    A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    The Take a STAND for health
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from baseline to follow-up on sedentary behaviour
    Description
    Sedentary behaviour will be assessed by ActivPAL™
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Change from baseline to follow-up on physical activity levels
    Description
    Physical activity levels will be assessed by ActiGraph GT3X®
    Time Frame
    4 months
    Title
    Change from baseline to follow-up on body composition
    Description
    Lean mass, fat mass and bone mass will be assessed by densitometry (DEXA)
    Time Frame
    4 months
    Title
    Change from baseline to follow-up on aerobic capacity
    Description
    Aerobic capacity will be assessed by a maximal cardiopulmonary exercise test
    Time Frame
    4 months
    Title
    Change from baseline to follow-up on food intake
    Description
    Food intake will be assessed by means of three 24-hours food recalls
    Time Frame
    4 months
    Title
    Change from baseline to follow-up on office and ambulatory blood pressure
    Description
    Office and ambulatory blood pressure will be assessed by automated devices
    Time Frame
    4 months (RCT) and 5 hours (crossover)
    Title
    Change from baseline to follow-up on quality of life
    Description
    Quality of life will be assessed by Bariatric Analysis and Reporting Outcome questionnaire
    Time Frame
    4 months
    Title
    Change from baseline to follow-up on functional capacity and fatigue
    Description
    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
    Title
    Change from baseline to follow-up on cardiovascular risk score
    Description
    Cardiovascular risk score will be assessed by Framingham score
    Time Frame
    4 months
    Title
    Change from baseline to follow-up on sleep apnea
    Description
    Sleep apnea will be assessed by polysomnography
    Time Frame
    4 months
    Title
    Change from baseline to follow-up on autonomic function
    Description
    Autonomic function will be assessed by heart rate variability
    Time Frame
    4 months
    Title
    Change from baseline to follow-up on cardiovascular and respiratory chemoreflex control
    Description
    Cardiovascular and respiratory chemoreflex control will be assessed by hyperoxia and hypoxia protocol
    Time Frame
    4 months
    Other Pre-specified Outcome Measures:
    Title
    Change from baseline to follow-up on vascular function
    Description
    Vascular function will be assessed by flow-mediated dilatation
    Time Frame
    4 months (RCT) and 5 hours (crossover)
    Title
    Change from baseline to follow-up on blood markers
    Description
    Insulin sensitivity: fasting glucose and insulin; Lipid profile: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
    Time Frame
    4 months (RCT) and 5 hours (crossover)
    Title
    Change from baseline to follow-up on inflammatory markers
    Description
    Pro- and anti-inflammatory cytokines: IL-1, IL-1ra, IL-6, IL-10 e TNF-alpha;
    Time Frame
    4 months
    Title
    Change from baseline to follow-up on oral glucose tolerance test
    Description
    Assessed in fasting, 30, 60, 90, and 120 minutes
    Time Frame
    4 months
    Title
    Protein expression
    Description
    Muscle sample assessed by means of western blotting
    Time Frame
    4 months (RCT) and 5 hours (crossover)
    Title
    Gene expression
    Description
    Muscle sample assessed by means of real-time PCR
    Time Frame
    4 months (RCT) and 5 hours (crossover)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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). -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bruno Gualano, Phd
    Phone
    55112661
    Ext
    8021
    Email
    gualano@usp.br

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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