Increasing Physical Activity Among Inactive Bariatric Surgery Patients (Bari-Active)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Physical Activity Weight Loss Health-related Quality of Life |
Behavioral: Intervention to increase physical activity |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Increasing Physical Activity Among Inactive Bariatric Surgery Patients |
- Changes in moderate-to-vigorous (MVPA) physical activity minutes and MVPA minutes occurring in bouts of 10 minutes or longer [ Time Frame: Post-intervention and 3- and 6-month postoperative follow-up ] [ Designated as safety issue: No ]
- Weight loss [ Time Frame: Post-intervention, 3- and 6-month postoperative follow-up ] [ Designated as safety issue: No ]
- Changes in health-related quality of life [ Time Frame: Post-intervention, 3- and 6-month postoperative follow-up ] [ Designated as safety issue: No ]
- Changes in physical activity self-efficacy and outcome expectations [ Time Frame: Post-intervention, 3- and 6-month postoperative follow-up ] [ Designated as safety issue: No ]
- Changes in physical activity enjoyment [ Time Frame: Post-intervention, 3- and 6-month postoperative follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
|
No Intervention: Standard care control
6 weeks of standard preoperative care
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
More Information
No publications provided
| 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, DK083438-01 |
| Study First Received: | August 19, 2009 |
| Last Updated: | April 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by The Miriam Hospital:
|
Physical activity Obesity Bariatric surgery Weight Loss |
Additional relevant MeSH terms:
|
Weight Loss Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013