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

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

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 Overview

• Status: Unknown
• Conditions: Obesity, Morbid; Bariatric Surgery
• Intervention / Treatment: Behavioral: The Take a STAND for health

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno Gualano, PhD; Phone Number: 8021 55112661; Email: gualano@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Take a STAND for health; 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; 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.
No Intervention: Control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to follow-up on vascular function	Vascular function will be assessed by flow-mediated dilatation	4 months (RCT) and 5 hours (crossover)
Change from baseline to follow-up on blood markers	Insulin sensitivity: fasting glucose and insulin; Lipid profile: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides	4 months (RCT) and 5 hours (crossover)
Change from baseline to follow-up on inflammatory markers	Pro- and anti-inflammatory cytokines: IL-1, IL-1ra, IL-6, IL-10 e TNF-alpha;	4 months
Change from baseline to follow-up on oral glucose tolerance test	Assessed in fasting, 30, 60, 90, and 120 minutes	4 months
Protein expression	Muscle sample assessed by means of western blotting	4 months (RCT) and 5 hours (crossover)
Gene expression	Muscle sample assessed by means of real-time PCR	4 months (RCT) and 5 hours (crossover)

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Anticipated): September 7, 2020
• Primary Completion (Anticipated): October 8, 2022
• Study Completion (Anticipated): October 8, 2022

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 26581219.6.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No