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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04517591
• Other study ID #: 26581219.6.0000.0068
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: October 8, 2022

Study information

• Verified date: August 2020
• Source: University of Sao Paulo
• Contact: Bruno Gualano, Phd
• Phone: 55112661
• Email: gualano[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 8, 2022
• Est. primary completion date: October 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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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Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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
Other	Change from baseline to follow-up on oral glucose tolerance test	Assessed in fasting, 30, 60, 90, and 120 minutes	4 months
Other	Protein expression	Muscle sample assessed by means of western blotting	4 months (RCT) and 5 hours (crossover)
Other	Gene expression	Muscle sample assessed by means of real-time PCR	4 months (RCT) and 5 hours (crossover)
Primary	Change from baseline to follow-up on sedentary behaviour	Sedentary behaviour will be assessed by ActivPAL™	4 months
Secondary	Change from baseline to follow-up on physical activity levels	Physical activity levels will be assessed by ActiGraph GT3X®	4 months
Secondary	Change from baseline to follow-up on body composition	Lean mass, fat mass and bone mass will be assessed by densitometry (DEXA)	4 months
Secondary	Change from baseline to follow-up on aerobic capacity	Aerobic capacity will be assessed by a maximal cardiopulmonary exercise test	4 months
Secondary	Change from baseline to follow-up on food intake	Food intake will be assessed by means of three 24-hours food recalls	4 months
Secondary	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)
Secondary	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
Secondary	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
Secondary	Change from baseline to follow-up on cardiovascular risk score	Cardiovascular risk score will be assessed by Framingham score	4 months
Secondary	Change from baseline to follow-up on sleep apnea	Sleep apnea will be assessed by polysomnography	4 months
Secondary	Change from baseline to follow-up on autonomic function	Autonomic function will be assessed by heart rate variability	4 months
Secondary	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