Clinical trial NCT00962325: Increasing Physical Activity Among Inactive Bariatric Surgery Patients (Bari-Active)
Official title: Increasing Physical Activity Among Inactive Bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Weight Loss
Health-related Quality of Life
Keywords: Physical activity
Obesity
Bariatric surgery
Weight Loss
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total
timeFrame: 6-week Post-intervention follow-up
Secondary outcomes:
measure: Change in MVPA, bout-related and total
timeFrame: 3- and 6-month postoperative follow-up
measure: Changes in health-related quality of life
timeFrame: 6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up
measure: Changes in physical activity self-efficacy and outcome expectations
timeFrame: Post-intervention follow-up, 3- and 6-month postoperative follow-up
measure: Changes in physical activity enjoyment
timeFrame: Post-intervention, 3- and 6-month postoperative follow-up
measure: Weight
timeFrame: post-intervention follow-up, 3- and 6-months postoperative
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital/Brown Alpert Medical School
name: Dale s Bond, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bond 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.