search
Back to results

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

Primary Purpose

Physical Activity, Weight Loss, Health-related Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention to increase physical activity
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Activity focused on measuring Physical activity, Obesity, Bariatric surgery, Weight Loss

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Weight Control and Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Activity behaviors counseling

Standard care control

Arm Description

6 weeks of standard preoperative care

Outcomes

Primary Outcome Measures

Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total

Secondary Outcome Measures

Change in MVPA, bout-related and total
Changes in health-related quality of life
Changes in physical activity self-efficacy and outcome expectations
Changes in physical activity enjoyment
Weight

Full Information

First Posted
August 19, 2009
Last Updated
March 14, 2016
Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT00962325
Brief Title
Increasing Physical Activity Among Inactive Bariatric Surgery Patients (Bari-Active)
Official Title
Increasing Physical Activity Among Inactive Bariatric Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Weight Loss, Health-related Quality of Life
Keywords
Physical activity, Obesity, Bariatric surgery, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Activity behaviors counseling
Arm Type
Experimental
Arm Title
Standard care control
Arm Type
No Intervention
Arm Description
6 weeks of standard preoperative care
Intervention Type
Behavioral
Intervention Name(s)
Intervention to increase physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in MVPA, bout-related and total
Time Frame
3- and 6-month postoperative follow-up
Title
Changes in health-related quality of life
Time Frame
6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up
Title
Changes in physical activity self-efficacy and outcome expectations
Time Frame
Post-intervention follow-up, 3- and 6-month postoperative follow-up
Title
Changes in physical activity enjoyment
Time Frame
Post-intervention, 3- and 6-month postoperative follow-up
Title
Weight
Time Frame
post-intervention follow-up, 3- and 6-months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale s Bond, Ph.D.
Organizational Affiliation
The Miriam Hospital/Brown Alpert Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28253045
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.
Results Reference
derived
PubMed Identifier
25304832
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs