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Fitbit / Healthy Weight Management Study

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ClinicalTrials.gov Identifier: NCT02381262
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
Louise von Hess Medical Research Institute
Information provided by (Responsible Party):
Lancaster General Hospital

Tracking Information
First Submitted Date  ICMJE February 24, 2015
First Posted Date  ICMJE March 6, 2015
Last Update Posted Date August 30, 2019
Study Start Date  ICMJE October 2015
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
Percentage of excess weight loss [ Time Frame: 1 year ]
Does the use of a Fitbit positively affect the percentage of excess body weight loss in VSG patients? Subjects enrolled in the study will have ideal body weight (IBW) calculated upon entry into the bariatric program and entered into the electronic health record. IBW calculations are based on the Met Life IBW charts. EWL at the end of one year will be calculated as follows: EWL% = (ABW - CW)/EBW *100 EWL%: Percentage of excess weight loss CW: Current weight (to be collected at regular intervals during the study, but for purposes of this objective, the measure collected at the 1 year visit) ABW: Actual body weight at baseline - date approved for surgery and entering pre-surgical period EBW: Excess body weight = ABW - IBW IBW: Ideal body weight based on Met Life IBW charts
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
  • Changes and physical activity patterns [ Time Frame: 1 year ]
    Does the use of a Fitbit foster positive physical activity pattern changes in post-operative VSG patients? Subjects will complete the International Physical Activity Questionnaire (IPAQ-LF) long form which consists of questions to assess physical activity over the past 7 days. The IPAQ will be administered at regular office visits to both the control and intervention groups at 2 weeks, 1 month, 4 months, 8 months, 1 year follow-up visits.
  • Resolution of comorbidity [ Time Frame: 1 year ]
    Does the use of a Fitbit positively affect patient health via reduction of co-morbid conditions associated with morbid obesity following VSG surgery? Subjects in all three groups will have standard comorbidity assessments for the following diseases:
    • Diabetes, based on number of diabetes medications and HA1C of 6.5
    • Hypertension, based on number of antihypertensives
    • Hyperlipidemia, based on number of lipid lowering medications and total cholesterol or triglyceride level of 200
    • Obstructive sleep apnea, based on use of CPAP or BiPAP These assessments will occur at baseline and at the 2 weeks, 1 month, 4 months, 8 months, 1 year follow-up visits.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fitbit / Healthy Weight Management Study
Official Title  ICMJE Fitbit / Healthy Weight Management Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Obesity
  • Bariatric Surgery
Intervention  ICMJE Behavioral: Fitbit
The Fitbit is a wrist based wearable technology device designed to monitor physical activity by tracking steps, distance and calories burned as well as sleep patterns and heart rate. It has wireless capabilities to sync with smart devices and summarize data for the user or export for synchronize with electronic health records.
Study Arms  ICMJE
  • Experimental: Intervention

    At the 2 week post-surgical visit, subjects will receive and be trained in the use of the Fitbit and data interface and meet with the exercise physiologist or research coordinator to initiate MyLGHealth, lifestyle/activity data collection.

    Subsequent data collection time-points correspond with follow-up post-surgical appointments either at each visit or the 2 week, 1 month, 4 month, 8 month or 12 month visit.

    Intervention: Behavioral: Fitbit
  • No Intervention: Control

    At the 2 week post-surgical visit, all subjects will then meet with the exercise physiologist or research coordinator to initiate MyLGHealth, lifestyle/activity data collection.

    Subsequent data collection time-points correspond with follow-up post-surgical appointments either at each visit or the 2 week, 1 month, 4 month, 8 month or 12 month visit.

    The control group will receive a current version of the Fitbit device at the end of their completion of the 12 month visit.

  • No Intervention: Historical Control
    The investigators will extract historical control data from the electronic health record using electronic queries and manual data extraction. Historical controls will have surgery and 12-month follow-up completed prior to the start of the RCT.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 5, 2015)
213
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02381262
Other Study ID Numbers  ICMJE 2015-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lancaster General Hospital
Study Sponsor  ICMJE Lancaster General Hospital
Collaborators  ICMJE Louise von Hess Medical Research Institute
Investigators  ICMJE
Principal Investigator: James Ku, MD Lancaster General Bariatric Surgery and Healthy Weight Management Programs
PRS Account Lancaster General Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP