Increasing Physical Activity Among Inactive Bariatric Surgery Patients (Bari-Active)
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| ClinicalTrials.gov Identifier: NCT00962325 |
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Recruitment Status :
Completed
First Posted : August 20, 2009
Last Update Posted : March 16, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Physical Activity Weight Loss Health-related Quality of Life | Behavioral: Intervention to increase physical activity | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Increasing Physical Activity Among Inactive Bariatric Surgery Patients |
| Study Start Date : | March 2009 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | June 2015 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Activity behaviors counseling |
Behavioral: Intervention to increase physical activity
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. |
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No Intervention: Standard care control
6 weeks of standard preoperative care
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- Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total [ Time Frame: 6-week Post-intervention follow-up ]
- 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 ]
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| Ages Eligible for Study: | 21 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962325
| United States, Rhode Island | |
| Weight Control and Diabetes Research Center | |
| Providence, Rhode Island, United States, 02903 | |
| Principal Investigator: | Dale s Bond, Ph.D. | The Miriam Hospital/Brown Alpert Medical School |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dale Bond, Assistant Professor (Research), The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT00962325 History of Changes |
| Obsolete Identifiers: | NCT00820066 |
| Other Study ID Numbers: |
DK83438 K01DK083438 ( U.S. NIH Grant/Contract ) DK083438-01 |
| First Posted: | August 20, 2009 Key Record Dates |
| Last Update Posted: | March 16, 2016 |
| Last Verified: | March 2016 |
Keywords provided by Dale Bond, The Miriam Hospital:
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Physical activity Obesity Bariatric surgery Weight Loss |
Additional relevant MeSH terms:
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Weight Loss Body Weight Changes Body Weight Signs and Symptoms |