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

Physical Activity Clinical Trial

Official title:

Increasing Physical Activity Among Inactive Bariatric Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962325
• Other study ID #: DK83438
• Secondary ID: K01DK083438DK083
• Status: Completed
• Phase: N/A
• First received: August 19, 2009
• Last updated: March 14, 2016
• Start date: March 2009
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00820066

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total		6-week Post-intervention follow-up	No
Secondary	Change in MVPA, bout-related and total		3- and 6-month postoperative follow-up	No
Secondary	Changes in health-related quality of life		6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up	No
Secondary	Changes in physical activity self-efficacy and outcome expectations		Post-intervention follow-up, 3- and 6-month postoperative follow-up	No
Secondary	Changes in physical activity enjoyment		Post-intervention, 3- and 6-month postoperative follow-up	No
Secondary	Weight		post-intervention follow-up, 3- and 6-months postoperative	No