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

NCT04517591 | Unknown

• 1 other identifier: 26581219.6.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity, Morbid; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Change from baseline to follow-up on sedentary behaviour

  Sedentary behaviour will be assessed by ActivPAL™

  4 months

Secondary Outcomes (11)

• Change from baseline to follow-up on physical activity levels

  4 months

• Change from baseline to follow-up on body composition

  4 months

• Change from baseline to follow-up on aerobic capacity

  4 months

• Change from baseline to follow-up on food intake

  4 months

• Change from baseline to follow-up on office and ambulatory blood pressure

  4 months (RCT) and 5 hours (crossover)

Other Outcomes (6)

• Change from baseline to follow-up on vascular function

  4 months (RCT) and 5 hours (crossover)

• Change from baseline to follow-up on blood markers

  4 months (RCT) and 5 hours (crossover)

• Change from baseline to follow-up on inflammatory markers

  4 months

Study Arms (2)

Take a STAND for health

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

The Take a STAND for health BEHAVIORAL

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.

Take a STAND for health

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Health

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Central Study Contacts

Bruno Gualano, Phd

CONTACT

55112661; gualano@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 18, 2020
• Study Start: September 7, 2020
• Primary Completion: October 8, 2022
• Study Completion: October 8, 2022
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share