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Promoting Physical Activity Among Bariatric Surgery Patients

NCT01722357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2020-06-11

No results posted yet for this study

Summary

The purpose of the study is to address 3 main sets of questions in the bariatric surgery population. 1) Does bariatric surgery, without any other intervention, lead to increased physical activity and improved physical fitness? 2) Does wearing a pedometer lead to increased physical activity in obese individuals prior to and/or after bariatric surgery? Does the increased activity result in improvements in physical fitness? 3) Does physical activity counseling increase physical activity prior to and or/after bariatric surgery? Does the increased activity result in improvements in physical fitness? The overall goal of the study is to determine the impact of bariatric surgery on physical activity and assess the utility of additional interventions to help postoperative patients adopt a more active lifestyle. Participants are randomized to usual care, pedometer use, or pedometer use plus exercise counseling before and for the first 6 months after bariatric surgery. In an extension of the primary study, from 1 to 5 years after surgery, all patients receive exercise counseling. Physiological measures will be assessed to determine whether bariatric surgery and/or improved physical activity levels result in improved physical fitness.

Conditions

Interventions

BEHAVIORAL

Pedometer

Participants are provided with Omron Model HJ-151 pedometers and given instruction on how to use the pedometer to set goals for increasing physical activity. They are given diaries to track their daily step counts.

BEHAVIORAL

Exercise Counseling

Manualized cognitive behavioral treatment program including goal setting, adding exercise throughout the day, physical limitations/injuries, maintaining motivation, benefits of exercise, FITT principles, exercise as recreation, and restructuring thoughts related to activity.

Sponsors & Collaborators

  • St. Vincent Foundation

    collaborator OTHER

  • Ascension St. Vincent Carmel Hospital

    lead OTHER

Principal Investigators

  • David B Creel, PhD · St. Vincent Carmel Hospital Bariatric Center of Excellence

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-07-31
Completion
2019-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01722357 on ClinicalTrials.gov