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Fitbit / Healthy Weight Management Study

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ClinicalTrials.gov Identifier: NCT02381262
Recruitment Status : Active, not recruiting
First Posted : March 6, 2015
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
Louise von Hess Medical Research Institute
Information provided by (Responsible Party):
Lancaster General Hospital

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?

Condition or disease Intervention/treatment Phase
Obesity Bariatric Surgery Behavioral: Fitbit Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Fitbit / Healthy Weight Management Study
Study Start Date : October 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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.

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.

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.



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.


  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381262


Locations
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Sponsors and Collaborators
Lancaster General Hospital
Louise von Hess Medical Research Institute
Investigators
Principal Investigator: James Ku, MD Lancaster General Bariatric Surgery and Healthy Weight Management Programs

Publications:

Responsible Party: Lancaster General Hospital
ClinicalTrials.gov Identifier: NCT02381262     History of Changes
Other Study ID Numbers: 2015-201
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lancaster General Hospital:
Fitbit