A Virtual Support Pilot Program for Weight Loss Surgery Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Baystate Medical Center
Sponsor:
Information provided by (Responsible Party):
Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT01770366
First received: January 15, 2013
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Weight
Physical Activity
Device: Weight and Exercise Lifestyle Support (WELS)
Device: Usual Care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Virtual Support Pilot Program for Weight Loss Surgery Patients Leveraging Wireless Goal-tracking Technologies

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • BMI [ Time Frame: 3 months post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • FitLinxx Pebble
  • FitLinxx ActiScale
  • FitLinxx ActiHealth website

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Baystate Medical Center Weight Loss Surgery Program patient scheduled to have weight loss surgery during the recruitment period
  • ≥18 years old (weight loss surgery patients younger than 18 years of age represent a unique population, such that an intervention geared towards adult patients would not be appropriate for this younger population)
  • English-speaking (research staff are English-speaking only, and we do not have funding available to hire interpreters or bilingual staff)

Exclusion Criteria:

  • Anyone judged not medically fit to participate in the study (e.g., severe medical or psychiatric problems), as per the physician's clinical judgment (by direct physician query)
  • Patients planning to relocate from the area within the next six months (i.e., during study timeframe)
  • Patients currently participating in another research study (due to patient burden and the potential for reduced protocol adherence associated with participation in multiple studies)
  • Patients weighing over 420 pounds at baseline (due to the weight range on the wireless weight scale, and to allow for some weight gain between the baseline research visit and the date of surgery)
  • Patients who do not have a computer with an internet connection in their home (due to the web-based nature of this virtual support program and the need to have the USB antenna set up in the patient's home to collect weight data)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770366

Contacts
Contact: Sofija E Zagarins, PhD 413-794-2876 sofija.zagarins@baystatehealth.org

Locations
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Sofija E Zagarins, PhD    413-794-2876    sofija.zagarins@baystatehealth.org   
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: Sofija E Zagarins, PhD Baystate Health and Tufts University School of Medicine
  More Information

No publications provided

Responsible Party: Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01770366     History of Changes
Other Study ID Numbers: BH-12-180
Study First Received: January 15, 2013
Last Updated: August 12, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
obesity
weight loss surgery
virtual support
wireless devices
Internet

Additional relevant MeSH terms:
Body Weight
Weight Loss
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014