Physical Activity Clinical Trial
Official title:
A Virtual Support Pilot Program for Weight Loss Surgery Patients Leveraging Wireless Goal-tracking Technologies
Obesity affects over one-third of the US population, and is associated with serious medical problems like diabetes and heart disease. Weight loss surgery is the most effective treatment for obesity, but some weight loss surgery patients lose less weight than others, and some patients regain the weight they lost. Researchers have found that support groups help post-surgical patients lose more weight, but long-term support programs often aren't available or are difficult for patients to get to. Physical activity is also important for weight loss surgery patients, but most post-surgical support programs don't focus on helping patients exercise. Our pilot study will test an Internet-based weight loss surgery support program that patients can use from home, and will include new devices such as wireless weight scales and wireless pedometers to help patients track their weight loss and physical activity and share their progress with their clinicians over the Internet. If successful, our support intervention will help more patients successfully lose weight after surgery, and therefore will improve their long-term health.
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).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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