Clinical trial NCT02381262: Fitbit / Healthy Weight Management Study
Official title: Fitbit / Healthy Weight Management Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Bariatric Surgery
Keywords: Fitbit
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
Collaborators: name: Louise von Hess Medical Research Institute
First posted: 2015-03-06
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study Aims Specifically with our Healthy Weight Management patients that are pursuing sleeve gastrectomy surgery, the investigators would like to determine if the Fitbit is associated with health outcomes in this population.

Primary Outcome

• Percentage of excess weight loss - Does the use of a Fitbit positively affect the percentage of excess body weight loss in vertical sleeve gastrectomy patients?

Secondary Outcomes

* Lifestyle changes and Exercise patterns - Does the use of a Fitbit foster positive lifestyle and exercise pattern changes in post-operative VSG patients?
* Resolution of comorbidity - Does the use of a Fitbit positively affect patient health via reduction of co-morbid conditions associated with morbid obesity following VSG surgery?

Detailed description: Study Aims Specifically with our Healthy Weight Management patients that are pursuing sleeve gastrectomy surgery, the investigators would like to determine if the Fitbit is associated with health outcomes in this population.

Primary Outcome

• Percentage of excess weight loss - Does the use of a Fitbit positively affect the percentage of excess body weight loss in vertical sleeve gastrectomy patients?

Secondary Outcomes

* Lifestyle changes and Exercise patterns - Does the use of a Fitbit foster positive lifestyle and exercise pattern changes in post-operative VSG patients?
* Resolution of comorbidity - Does the use of a Fitbit positively affect patient health via reduction of co-morbid conditions associated with morbid obesity following VSG surgery?

Research Methodology This study will be focused on a bariatric post-surgical population and is designed as a randomized controlled trial (RCT) with three arms; a RCT with a control and intervention group and a historical control group. For the RCT, subjects, after providing informed consent, will be randomized into either the control arm or the intervention arm. In the control arm, subjects will be provided normal/standard of care for post-surgical bariatric patients. This includes physician visits, dietary and exercise consults, education and other therapy as appropriate for their care. In the intervention arm, subjects will be provided with a Fitbit bracelet and software to monitor their physical activity in addition to the normal/standard of care provided in the control group. Both groups will receive the recommended aerobic and strength training exercise guidelines. Furthermore, each group will have identical exercise education regarding appropriate intensity using either rate of perceived exertion or target heart rate range. At the end of the 12-month tracking period of the study, the control group will be provided with a Fitbit bracelet so that they can begin tracking their activity levels during the 2nd post-operative year. A third group, the historical controls, at the end of the study will be extracted from the electronic medical records from patients who have meet the same inclusion/exclusion criteria and were surgical patients with completed follow-up prior to the start of the RCT portion of the trial.

RCT subjects randomized to the intervention group will be provided with step by step instructions on how to set-up the Fitbit app on their smartphone and or view the data on the Fitbit secure portal. Additionally, subjects will be shown how to track their weekly structured aerobic and strength training exercise within the app. Users will also be shown how to access Fitbit data on the MyLGHealth portal. Data from the Fitbit will also be accessible to the provider on EPIC flow sheets. Providers will be able to incorporate this data into discussions with patient at visits. RCT subjects randomized to the control group will receive the same training and a Fitbit device after they complete their 12 month visit.

Just prior to the start of the RCT, we will be conducting a pilot study to test the implementation of the Fitbit in this patient population. The pilot phase will initially target 5 patients to enroll as a test of the set-up of the Fitbit monitoring, data transfer, activity logs and other data collection procedures. Subjects in this pilot phase will only participate for a period of 1 month and all individuals will receive a Fitbit device. The investigators will employ all inclusion/exclusion criteria, recruitment procedures and complete all data collection procedures (baseline and follow-up) as planned for the randomized trial. If additional adjustments need to be made relative to the Fitbit set-up or training/reference materials for patients, another 5 pilot patients may be recruited. Data collection and study procedures on all pilot subjects will be completed before the randomized trial begins. This pilot study will be submitted to the IRB for review and approval as a separate study prior to the RCT portion of the study.

For the RCT portion of the study, subjects will be recruited, enrolled and randomized into the study and then baseline data will be collected and entered into the study database. These data elements include subject demographics (age, gender, weight entering program, preoperative weight, comorbidities, lifestyle and physical activity patterns, etc.). Subjects will be followed for one year or until lost to follow-up with data collected at each physician office visit. At each office visit, the investigators will extract from Epic the date of the visit, subject weight and comorbidities. Lifestyle and physical activity patterns will only be assessed at the 2 week, 1 month, 4 month, 8 month and 12 month visits. The historical control group will be extracted at the end of the study when RCT subjects are nearing the completion of their 12 month follow-up.

The historical controls will consist of a group of patients that will have already received surgery and completed 12 month follow-up prior to the start of the pilot and RCT portions of the project. There will be no interaction with them as a part of the study. The investigators are planning to identify them and collect data at the end of the RCT portion of the project.

Eligibility criteria: Inclusion Criteria:

* Naive bariatric surgery procedure patients - approved for surgery
* Laparoscopic VSG patients
* Completion of all pre-surgical requirements
* Age ≥ 18
* Subject must have a My LG Health account activated
* Subject must have a PC and/or Bluetooth enabled device at home

Exclusion Criteria:

* Band procedures
* Revisions
* All other bariatric procedures
* Non-English speaking patient (justification - My LG Health information and support is only available in English)
* Already own and use a Fitbit type device
* Cognitive impairments or lack of support that would limit the abilities to comply with study procedures or use of a diary/Fitbit

Primary outcomes:
measure: Percentage of excess weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Changes and physical activity patterns
timeFrame: 1 year
measure: Resolution of comorbidity
timeFrame: 1 year
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
Study officials:
affiliation: Lancaster General Bariatric Surgery and Healthy Weight Management Programs
name: James Ku, MD
role: PRINCIPAL_INVESTIGATOR
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