Increasing Physical Activity Among Inactive Bariatric Surgery Patients (Bari-Active)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Physical Activity; Weight Loss; Health-related Quality of Life	Behavioral: Intervention to increase physical activity	Not Applicable

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

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
No Intervention: Standard care control; 6 weeks of standard preoperative care

Outcome Measures

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Primary Outcome Measures :

1. Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total [ Time Frame: 6-week Post-intervention follow-up ]

Secondary Outcome Measures :

1. Change in MVPA, bout-related and total [ Time Frame: 3- and 6-month postoperative follow-up ]
2. Changes in health-related quality of life [ Time Frame: 6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up ]
3. Changes in physical activity self-efficacy and outcome expectations [ Time Frame: Post-intervention follow-up, 3- and 6-month postoperative follow-up ]
4. Changes in physical activity enjoyment [ Time Frame: Post-intervention, 3- and 6-month postoperative follow-up ]
5. Weight [ Time Frame: post-intervention follow-up, 3- and 6-months postoperative ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Locations

United States, Rhode Island
Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

The Miriam Hospital

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:	Dale s Bond, Ph.D.	The Miriam Hospital/Brown Alpert Medical School

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
Last Update Posted:	March 16, 2016
Last Verified:	March 2016

Keywords provided by Dale Bond, The Miriam Hospital:

Physical activity; Obesity; Bariatric surgery; Weight Loss

Additional relevant MeSH terms:

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms