Increasing Physical Activity Among Inactive Bariatric Surgery Patients - Full Text View

Sponsored by:	The Miriam Hospital
Information provided by:	The Miriam Hospital
ClinicalTrials.gov Identifier:	NCT00820066

Purpose

The purpose of this study is to compare the effects of a behavioral intervention targeting increases in physical activity, a behavioral intervention targeting decreases in sedentary behaviors, and a standard care control group on changes in preoperative and postoperative physical activity among bariatric surgery patients with low levels of physical activity.

Condition	Intervention
Physical Activity	Behavioral: Treatment to increase physical activity Behavioral: Treatment to decrease sedentary behaviors

MedlinePlus related topics: Weight Loss Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Increasing Physical Activity Among Inactive Bariatric Surgery Patients

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:

Changes in objective moderate-to-vigorous (MVPA) physical activity and MVPA minutes occurring in bouts of 10 minutes or longer [ Time Frame: Postintervention (8 weeks) and 6-month postoperative follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in body weight, body mass index, percentage of postoperative excess weight loss [ Time Frame: Postintervention, 6-month follow-up ] [ Designated as safety issue: No ]
Changes in health-related quality of life [ Time Frame: Postintervention, 6-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Treatment to increase physical activity: Experimental	Behavioral: Treatment to increase physical activity This will be an 8-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.
2: Treatment to decrease sedentary behaviors: Experimental	Behavioral: Treatment to decrease sedentary behaviors This will be an 8-week preoperative intervention to decrease sedentary behaviors performed during leisure time. 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.
3: Standard Care Control: No Intervention 8 weeks of standard preoperative surgical care.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
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:

Currently active, defined as current participation in structured physical activity program or reporting 150 or more weekly minutes of moderate-to-vigorous physical activity in bouts of least 10 minutes
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820066

Locations

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

Sponsors and Collaborators

The Miriam Hospital

Investigators

Principal Investigator:

Dale S Bond, PhD

The Miriam Hospital

More Information

Responsible Party:	The Miriam Hospital ( Dale S. Bond, Ph.D. )
Study ID Numbers:	2054-08
Study First Received:	January 8, 2009
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00820066
Health Authority:	United States: Institutional Review Board

Keywords provided by The Miriam Hospital:

obesity
bariatric surgery
physical activity
sedentary behaviors

Study placed in the following topic categories:

Obesity

ClinicalTrials.gov processed this record on January 16, 2009