A Virtual Support Pilot Program for Weight Loss Surgery Patients
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|ClinicalTrials.gov Identifier: NCT01770366|
Recruitment Status : Completed
First Posted : January 17, 2013
Results First Posted : March 13, 2015
Last Update Posted : March 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Weight Physical Activity||Device: Weight and Exercise Lifestyle Support (WELS) Device: Usual Care||Phase 1 Phase 2|
For the proposed pilot study, a primary objective will be to determine the usability of and satisfaction with a virtual weight loss support program incorporating home-based goal-tracking technology (e.g., home weighing, activity monitoring). FitLinxx, Inc. has been selected to partner in the proposed research as they offer a weight scale (ActiScaleTM) and activity monitor (PebbleTM) that can transmit collected data to a secure patient portal website (ActiHealth.com) via state-of-the-art wireless data transmission technology. In addition to viewing their device data on this patient portal website, program participants will be able to communicate as desired with other weight loss surgery patients though a chat room feature on the patient portal website, and will also be invited to participate in activity and weight loss challenges on the website (e.g., weekly step count challenges, weekly percent excess weight loss challenges). E-mail will be used as a means of virtual social exchange between patients and providers, as opposed to the synchronous, face-to-face support groups at the hospital. The virtual patient support program and goal-tracking technology described above provide a novel, scalable and cost effective model of patient support that is associated with minimal patient burden.
This will be a four-month pilot study of the virtual patient support program described above and will enroll a total of 24 pre-surgical patients recruited from the Weight Loss Surgery (WLS) program at Baystate Medical Center (BMC) who are scheduled to have weight loss surgery within four to six weeks of enrollment. The final target sample size is 18, which reflects a goal of six patients of each surgical type (e.g., roux-en-Y gastric bypass [RNY], laparoscopic gastric banding [LGB], laparoscopic sleeve gastrectomy [LSG]), with three in each group randomized to receive the intervention and three randomized to the control group. Eligible patients must have a computer with Internet access in their home (to transmit device data and view the patient portal website), and must weigh less than 420 pounds at baseline (due to the 440-pound limit of our weight scale and to allow for some weight gain between the baseline research visit and the date of surgery). The sample size and recruitment period are feasible given the approximately 400 patients having weight loss surgery at Baystate every year (estimate based on figures from 2006-2010).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Virtual Support Pilot Program for Weight Loss Surgery Patients Leveraging Wireless Goal-tracking Technologies|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Placebo Comparator: Usual Care
Patients will receive usual care from the post-surgical clinic team.
|Device: Usual Care|
Experimental: Intervention Condition
Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.
Device: Weight and Exercise Lifestyle Support (WELS)
Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired.
- BMI [ Time Frame: 3 months post surgery ]
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): NCT01770366
|United States, Massachusetts|
|Baystate Medical Center|
|Springfield, Massachusetts, United States, 01199|
|Principal Investigator:||Sofija E Zagarins, PhD||Baystate Health and Tufts University School of Medicine|