Bariatric Surgery Telemedicine Study

Obesity Clinical Trial

Official title:

A Telehealth Innovation to Support Weight Loss

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01378897
• Other study ID #: BH-11-059
• Status: Withdrawn
• Phase: Phase 1
• First received: June 21, 2011
• Last updated: August 10, 2016
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: August 2016
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Baystate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	usability questionnaire	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.	2 month	No