Bariatric Surgery Telemedicine Study

NCT01378897 | Withdrawn Phase 1

• 1 other identifier: BH-11-059
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

bariatric surgery; gastric bypass surgery

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

MedSignals®pillbox,Omron pedometer,VitalSignals®weight scale DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01105, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Garry W Welch, PhD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 23, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

US (1)