Clinical Trials Directory

Trials / Completed

CompletedNCT00962325

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

Increasing Physical Activity Among Inactive Bariatric Surgery Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
The Miriam Hospital · Academic / Other
Sex
All
Age
21 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIntervention to increase physical activityThis 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.

Timeline

Start date
2009-03-01
Primary completion
2014-04-01
Completion
2015-06-01
First posted
2009-08-20
Last updated
2016-03-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00962325. Inclusion in this directory is not an endorsement.