Obesity, MorbidNCT04517591
Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study
A study testing The Take a STAND for health in people with Obesity, Morbid and Bariatric Surgery, run by University of Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery
- What is being tested?
- The Take a STAND for health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2020to 8 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
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).
-
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Obesity, Morbid, Bariatric Surgery
- Being tested
- The Take a STAND for health
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Take a STAND for healthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Take a STAND for health | Experimental | A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to follow-up on sedentary behaviour
Sedentary behaviour will be assessed by ActivPAL™
Measured: 4 months
Secondary outcomes (11)
Change from baseline to follow-up on physical activity levels
Physical activity levels will be assessed by ActiGraph GT3X®
Measured: 4 months
Change from baseline to follow-up on body composition
Lean mass, fat mass and bone mass will be assessed by densitometry (DEXA)
Measured: 4 months
Change from baseline to follow-up on aerobic capacity
Aerobic capacity will be assessed by a maximal cardiopulmonary exercise test
Measured: 4 months
Change from baseline to follow-up on food intake
Food intake will be assessed by means of three 24-hours food recalls
Measured: 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
Measured: 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
Measured: 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.
Measured: 4 months
Change from baseline to follow-up on cardiovascular risk score
Cardiovascular risk score will be assessed by Framingham score
Measured: 4 months
Change from baseline to follow-up on sleep apnea
Sleep apnea will be assessed by polysomnography
Measured: 4 months
Change from baseline to follow-up on autonomic function
Autonomic function will be assessed by heart rate variability
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start7 Sep 2020 (estimated)
- Primary completion8 Oct 2022 (estimated)
- Study completion8 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517591
- Sponsor's protocol ID
- 26581219.6.0000.0068
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Time in Post-bariatric Patients: The Take a STAND for Health Study
- ClinicalTrials.gov ID
- NCT04517591
- Acronym / sponsor ID
- 26581219.6.0000.0068
- Conditions
- Obesity, Morbid, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 7 Sep 2020 (estimated)
- Primary completion
- 8 Oct 2022 (estimated)
- Study completion
- 8 Oct 2022 (estimated)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Take a STAND for health | Experimental | Behavioral: The Take a STAND for healthA newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity |
| 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Take a STAND for healthA 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. | Behavioural | Take a STAND for health |
Primary outcome
Change from baseline to follow-up on sedentary behaviour
Time frame: 4 months
Sedentary behaviour will be assessed by ActivPAL™
11 secondary outcomes
Change from baseline to follow-up on physical activity levels
Time frame: 4 months
Change from baseline to follow-up on body composition
Time frame: 4 months
Change from baseline to follow-up on aerobic capacity
Time frame: 4 months
Change from baseline to follow-up on food intake
Time frame: 4 months
Change from baseline to follow-up on office and ambulatory blood pressure
Time frame: 4 months (RCT) and 5 hours (crossover)
Change from baseline to follow-up on quality of life
Time frame: 4 months
Change from baseline to follow-up on functional capacity and fatigue
Time frame: 4 months
Change from baseline to follow-up on cardiovascular risk score
Time frame: 4 months
Change from baseline to follow-up on sleep apnea
Time frame: 4 months
Change from baseline to follow-up on autonomic function
Time frame: 4 months
Change from baseline to follow-up on cardiovascular and respiratory chemoreflex control
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Obesity, Morbid
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing The Take a STAND for health in people with Obesity, Morbid and Bariatric Surgery, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Gualano, Phd (55112661 ext. 8021, gualano@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to follow-up on sedentary behaviour (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.