Physical ActivityNCT00962325
Increasing Physical Activity Among Inactive Bariatric Surgery Patients (Bari-Active)
A study testing Intervention to increase physical activity in people with Physical Activity and Weight Loss, run by The Miriam Hospital at 1 site in United States.
Trial summary
For the growing number of severely obese individuals, there are currently few effective long-term weight control options with the exception of bariatric surgery. However, behavioral factors including low physical activity can undermine successful surgical outcomes. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Weight Loss, Health-related Quality of Life
- What is being tested?
- Intervention to increase physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2015
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI equal to or greater than 40 or greater than or equal to 35 (in presence of significant comorbidities)
- Have elected to undergo Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding
- Able to engage in activities of daily living
- Currently inactive, defined as less than 150 weekly minutes of moderate-to-vigorous physical activity in bouts of 10 minutes or more
- Obtainment of written consent from surgeon to participate
Who cannot join
- Unable to engage in activities of daily living
- Report conditions that would render the participant unlikely to follow the study protocol (e.g., relocation, substance abuse, severe psychiatric condition)
- Inability to understand program instructions due to language barrier or a mental disability
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Increasing Physical Activity Among Inactive Bariatric Surgery Patients
For the growing number of severely obese individuals, there are currently few effective long-term weight control options with the exception of bariatric surgery. However, behavioral factors including low physical activity can undermine successful surgical outcomes. This study will compare the effects of a behavioral physical activity intervention with a standard care control condition on changes in physical activity among inactive adult bariatric surgery patients.
Read the detailed description
The proportion of Americans who are severly obese or more than 100 pounds overweight is rapidly increasing. This presents a significant public health challenge as severely obese individuals have a higher rate of comorbidities and exact a greater toll on the health care system than less obese persons. For these individuals, bariatric surgery is currently the treatment of choice for producing substantial and long-term weight loss, although outcomes vary. Low physical activity is one behavioral factor that undermines surgical success. However, structured behavioral interventions to increase physical activity in bariatric surgery patients have not been conducted.
This study involves a randomized controlled trial that compares the effects of a behavioral intervention to increase physical activity with a standard care control group on changes in physical activity among adult bariatric surgery patients with low physical activity. Eighty bariatric surgery patients will be assigned to 6 weeks of either preoperative: (1) intervention to increase physical activity or (2) standard care control. Participants in the intervention group will receive individual, face-to-face sessions involving tailored instruction in use of standard behavior change strategies such as self-monitoring, goal setting and stimulus control. The PA intervention will focus on increasing home-based walking exercise. Physical activity will be objectively measured for 7 consecutive days via accelerometry at baseline/pre-intervention, post-intervention, and 3- and 6-months postoperative follow-up. At each time point, the groups will be compared on total moderate-to-vigorous physical activity (MVPA) minutes and MVPA minutes occurring in bouts of 10 minutes or longer. This study will test whether the behavioral physical activity intervention produces greater increases in pre- and post-operative physical activity than standard care. The long-term goal of this research is to improve bariatric surgery outcomes through innovative behavioral strategies to increase physical activity.
- Being tested
- Intervention to increase physical activity
- Keywords
- Physical activity, Obesity, Bariatric surgery, Weight Loss
- Medical subject headings
- Motor Activity, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention to increase physical activityBehavioural
This will be a 6-week preoperative intervention to increase structured walking activity. This will be accomplished through weekly individual face-to-face sessions involving tailored instruction in use of standard behavior change strategies such as self-monitoring, goal-setting, stimulus control, etc.
| Study group | Role | What they receive |
|---|---|---|
| Activity behaviors counseling | Experimental | Not described Receives: Behavioral: Intervention to increase physical activity |
| Standard care control | No intervention | 6 weeks of standard preoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total
Measured: 6-week Post-intervention follow-up
Secondary outcomes (5)
Change in MVPA, bout-related and total
Measured: 3- and 6-month postoperative follow-up
Changes in health-related quality of life
Measured: 6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up
Changes in physical activity self-efficacy and outcome expectations
Measured: Post-intervention follow-up, 3- and 6-month postoperative follow-up
Changes in physical activity enjoyment
Measured: Post-intervention, 3- and 6-month postoperative follow-up
Weight
Measured: post-intervention follow-up, 3- and 6-months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dale Bond, The Miriam Hospital
- Investigators
- Dale s Bond, Ph.D., Principal investigator, The Miriam Hospital/Brown Alpert Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962325
- Sponsor's protocol ID
- DK83438
- Other IDs
- K01DK083438, DK083438-01
- Status last verified
- Mar 2016
- First submitted
- 19 Aug 2009
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bond DS, Raynor HA, Thomas JG, Unick J, Webster J, Ryder B, Vithiananthan S. Greater Adherence to Recommended Morning Physical Activity is Associated With Greater Total Intervention-Related Physical Activity Changes in Bariatric Surgery Patients. J Phys Act Health. 2017 Jun;14(6):492-498. doi: 10.1123/jpah.2016-0529. Epub 2017 Mar 2.
PubMed 28253045Bond DS, Vithiananthan S, Thomas JG, Trautvetter J, Unick JL, Jakicic JM, Pohl D, Ryder BA, Roye GD, Sax HC, Wing RR. Bari-Active: a randomized controlled trial of a preoperative intervention to increase physical activity in bariatric surgery patients. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):169-77. doi: 10.1016/j.soard.2014.07.010. Epub 2014 Jul 30.
PubMed 25304832
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity Among Inactive Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT00962325
- Acronym / sponsor ID
- DK83438
- Keywords
- Physical activity, Obesity, Bariatric surgery, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Aug 2009 (estimated)
- 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.
For the growing number of severely obese individuals, there are currently few effective long-term weight control options with the exception of bariatric surgery. However, behavioral factors including low physical activity can undermine successful surgical outcomes. This study will compare the effects of a behavioral physical activity intervention with a standard care control condition on changes in physical activity among inactive adult bariatric surgery patients.
Detailed description
The proportion of Americans who are severly obese or more than 100 pounds overweight is rapidly increasing. This presents a significant public health challenge as severely obese individuals have a higher rate of comorbidities and exact a greater toll on the health care system than less obese persons. For these individuals, bariatric surgery is currently the treatment of choice for producing substantial and long-term weight loss, although outcomes vary. Low physical activity is one behavioral factor that undermines surgical success. However, structured behavioral interventions to increase physical activity in bariatric surgery patients have not been conducted.
This study involves a randomized controlled trial that compares the effects of a behavioral intervention to increase physical activity with a standard care control group on changes in physical activity among adult bariatric surgery patients with low physical activity. Eighty bariatric surgery patients will be assigned to 6 weeks of either preoperative: (1) intervention to increase physical activity or (2) standard care control. Participants in the intervention group will receive individual, face-to-face sessions involving tailored instruction in use of standard behavior change strategies such as self-monitoring, goal setting and stimulus control. The PA intervention will focus on increasing home-based walking exercise. Physical activity will be objectively measured for 7 consecutive days via accelerometry at baseline/pre-intervention, post-intervention, and 3- and 6-months postoperative follow-up. At each time point, the groups will be compared on total moderate-to-vigorous physical activity (MVPA) minutes and MVPA minutes occurring in bouts of 10 minutes or longer. This study will test whether the behavioral physical activity intervention produces greater increases in pre- and post-operative physical activity than standard care. The long-term goal of this research is to improve bariatric surgery outcomes through innovative behavioral strategies to increase physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity behaviors counseling | Experimental | Behavioral: Intervention to increase physical activity |
| Standard care control | No intervention | –6 weeks of standard preoperative care |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI equal to or greater than 40 or greater than or equal to 35 (in presence of significant comorbidities)
- Have elected to undergo Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding
- Able to engage in activities of daily living
- Currently inactive, defined as less than 150 weekly minutes of moderate-to-vigorous physical activity in bouts of 10 minutes or more
- Obtainment of written consent from surgeon to participate
Key exclusion criteria (3 listed)
- Unable to engage in activities of daily living
- Report conditions that would render the participant unlikely to follow the study protocol (e.g., relocation, substance abuse, severe psychiatric condition)
- Inability to understand program instructions due to language barrier or a mental disability
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 |
|---|---|---|
| Intervention to increase physical activityThis will be a 6-week preoperative intervention to increase structured walking activity. This will be accomplished through weekly individual face-to-face sessions involving tailored instruction in use of standard behavior change strategies such as self-monitoring, goal-setting, stimulus control, etc. | Behavioural | Activity behaviors counseling |
Primary outcome
Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total
Time frame: 6-week Post-intervention follow-up
5 secondary outcomes
Change in MVPA, bout-related and total
Time frame: 3- and 6-month postoperative follow-up
Changes in health-related quality of life
Time frame: 6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up
Changes in physical activity self-efficacy and outcome expectations
Time frame: Post-intervention follow-up, 3- and 6-month postoperative follow-up
Changes in physical activity enjoyment
Time frame: Post-intervention, 3- and 6-month postoperative follow-up
Weight
Time frame: post-intervention follow-up, 3- and 6-months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Derived from this study: PubMed 28253045Bond DS, Raynor HA, Thomas JG, Unick J, Webster J, Ryder B, Vithiananthan S. Greater Adherence to Recommended Morning Physical Activity is Associated With Greater Total Intervention-Related Physical Activity Changes in Bariatric Surgery Patients. J Phys Act Health. 2017 Jun;14(6):492-498. doi: 10.1123/jpah.2016-0529. Epub 2017 Mar 2.
- Derived from this study: PubMed 25304832Bond DS, Vithiananthan S, Thomas JG, Trautvetter J, Unick JL, Jakicic JM, Pohl D, Ryder BA, Roye GD, Sax HC, Wing RR. Bari-Active: a randomized controlled trial of a preoperative intervention to increase physical activity in bariatric surgery patients. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):169-77. doi: 10.1016/j.soard.2014.07.010. Epub 2014 Jul 30.
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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.
Dale s Bond, Ph.D. principal investigator
The Miriam Hospital/Brown Alpert Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention to increase physical activity in people with Physical Activity and Weight Loss, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total (time frame: 6-week Post-intervention follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00962325, which also lists 2 linked publications.
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 16 Mar 2016.