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

March 14, 2016 updated by: Dale Bond, The Miriam Hospital

Increasing Physical Activity Among Inactive Bariatric Surgery Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in MVPA, bout-related and total
Time Frame: 3- and 6-month postoperative follow-up
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
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
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
Post-intervention, 3- and 6-month postoperative follow-up
Weight
Time Frame: post-intervention follow-up, 3- and 6-months postoperative
post-intervention follow-up, 3- and 6-months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 19, 2009

First Submitted That Met QC Criteria

August 19, 2009

First Posted (Estimate)

August 20, 2009

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK83438
  • K01DK083438 (U.S. NIH Grant/Contract)
  • DK083438-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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