WeightPhase 1/2NCT01770366
A Virtual Support Pilot Program for Weight Loss Surgery Patients
A Phase 1/2 study testing Weight and Exercise Lifestyle Support (WELS) in people with Weight and Physical Activity, run by Baystate Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight, Physical Activity
- What is being tested?
- Weight and Exercise Lifestyle Support (WELS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
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.
Read the 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).
- Conditions
- Weight, Physical Activity
- Being tested
- Weight and Exercise Lifestyle Support (WELS), Usual Care
- Keywords
- obesity, weight loss surgery, virtual support, wireless devices, Internet
- Medical subject headings
- Body Weight, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight and Exercise Lifestyle Support (WELS)Device
Also called FitLinxx Pebble, FitLinxx ActiScale, FitLinxx ActiHealth website
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.
Usual CareDevice
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Patients will receive usual care from the post-surgical clinic team. Receives: Device: Usual Care |
| Intervention Condition | Experimental | 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. Receives: Device: Weight and Exercise Lifestyle Support (WELS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofija E Zagarins, PhD, Principal investigator, Baystate Health and Tufts University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770366
- Sponsor's protocol ID
- BH-12-180
- Status last verified
- Mar 2015
- First submitted
- 15 Jan 2013
- Last updated
- 13 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Support Pilot Program for Weight Loss Surgery Patients Leveraging Wireless Goal-tracking Technologies
- ClinicalTrials.gov ID
- NCT01770366
- Acronym / sponsor ID
- BH-12-180
- Conditions
- Weight, Physical Activity
- Keywords
- obesity, weight loss surgery, virtual support, wireless devices, Internet
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Posted 13 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Device: Usual CarePatients will receive usual care from the post-surgical clinic team. |
| Intervention Condition | Experimental | Device: Weight and Exercise Lifestyle Support (WELS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight and Exercise Lifestyle Support (WELS)Also: FitLinxx Pebble, FitLinxx ActiScale, FitLinxx ActiHealth websiteIntervention 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. | Device | Intervention Condition |
| Usual Care | Device | Usual Care |
Primary outcome
BMI
Time frame: 3 months post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofija E Zagarins, PhD principal investigator
Baystate Health and Tufts University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Weight and Exercise Lifestyle Support (WELS) in people with Weight and Physical Activity, run by Baystate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 3 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.