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Bariatric Surgery Telemedicine Study

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ClinicalTrials.gov Identifier: NCT01378897
Recruitment Status : Withdrawn (PI decided to not initiate this study.)
First Posted : June 23, 2011
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Baystate Medical Center

Brief Summary:
The purpose of this study is to evaluate a new educational program for people who have recently had gastric bypass surgery. This program involves both the use of newly developed wireless home monitoring technology (medication box, weight scale, and pedometer) and telephone-based, individually tailored health counseling with a bariatric dietician.

Condition or disease Intervention/treatment Phase
Obesity Device: MedSignals®pillbox,Omron pedometer,VitalSignals®weight scale Phase 1

Detailed Description:
Obesity, defined as a body mass index (BMI) >30 in kg/m2, has reached epidemic levels in the United States (US). Morbid obesity, which is classified as a BMI>=40, is the fastest growing obesity category. It has increased 52% between 2000 and 2005, to now affect 15 million US adults. Morbid obesity is associated with serious medical co-morbidities, and these obesity-related diseases have a significant impact on the individual patient, as well as on our healthcare system as a whole. Gastric bypass surgery is the only current effective treatment for MO. Approximately 220,000 operations were carried out in 2008, making it one of the most commonly performed procedures in the U.S. The most common form (80%) of bariatric surgery performed in the U.S. is laparoscopic gastric bypass (LGB). While there has been considerable clinical focus on multidisciplinary pre-surgical screening regarding medical, behavioral, and psychosocial suitability of candidates for bariatric surgery, there is a paucity of post-surgical follow-up examining behavioral adaptation and adherence. The purpose of this study is to examine such post-surgical behavioral components that are relevant to weight loss surgery. Specifically, the investigators will assess the feasibility, reliability, usability, and satisfaction of some newly developed wireless home monitoring technology (i.e., medication box, weight scale, and pedometer) in a group of patients who have recently had gastric bypass surgery. A prospective cohort study design will be conducted. Questionnaire data will be collected and data analysis will be descriptive in nature.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Telehealth Innovation to Support Weight Loss
Study Start Date : June 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: MedSignals®pillbox,Omron pedometer,VitalSignals®weight scale
    Participants will use three home monitoring devices (i.e., weight scale, pedometer, pillbox) for two months. In addition, participants will receive weekly phone calls from the study's bariatric dietician during weeks 1-4 of the study and then receive biweekly calls during the second month. The structured phone calls (approximately 10-15 minutes each call) will focus on discussing the patient's adherence data, discussing any barriers to adherence, and providing tailored patient education.


Primary Outcome Measures :
  1. usability questionnaire [ Time Frame: 2 month ]
    This pilot study involves the collection of descriptive data to assess feasibility, usability, and satisfaction with the devices. ). The method for collecting study data will be questionnaires (i.e., usability questionnaire, treatment satisfaction questionnaire, and feasibility questionnaire) and electronic data from the device downloads.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 weeks-1 year post gastric bypass surgery
  • > 18 years of age
  • English-speaking and able to read and understand consent form and study questionnaires.
  • Land line analog telephone service at home

Exclusion Criteria:

  • Suffered unexpected complications from surgery as judged by the surgeons
  • Anyone judged not fit to participate in the study, as per the surgeon or dietician's clinical judgment
  • Weight >440 lbs. at enrollment (upper limit of our weight scale)
  • Planning to relocate from the area within the next 2-3 months (i.e., during study timeframe)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378897


Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01105
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: Garry W Welch, PhD Baystate Medical Center

Responsible Party: Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01378897     History of Changes
Other Study ID Numbers: BH-11-059
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Keywords provided by Baystate Medical Center:
bariatric surgery
gastric bypass surgery