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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Dale Bond, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00962325
First received: August 19, 2009
Last updated: March 14, 2016
Last verified: March 2016
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total [ Time Frame: 6-week Post-intervention follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in MVPA, bout-related and total [ Time Frame: 3- and 6-month postoperative follow-up ] [ Designated as safety issue: No ]
  • Changes in health-related quality of life [ Time Frame: 6-week Post-intervention follow-up, 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 follow-up, 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 ]
  • Weight [ Time Frame: post-intervention follow-up, 3- and 6-months postoperative ] [ Designated as safety issue: No ]
Enrollment: 80
Study Start Date: March 2009
Study Completion Date: June 2015
Primary Completion Date: April 2014 (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 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962325

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

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

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: March 14, 2016
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 September 28, 2016