NCT01378897

Bariatric Surgery Telemedicine Study

A Telehealth Innovation to Support Weight Loss

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baystate Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-06-23
• Last updated: 2016-08-11

Locations

1 site across 1 country: United States