Fitbit / Healthy Weight Management Study

NCT02381262 | Completed

• 1 other identifier: 2015-201
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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?

Conditions

Obesity; Bariatric Surgery

Keywords

Fitbit

Outcome Measures

Primary Outcomes (1)

• Percentage of excess weight loss

  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

  1 year

Secondary Outcomes (2)

• Changes and physical activity patterns

  1 year

• Resolution of comorbidity

  1 year

Study Arms (3)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Historical Control

NO INTERVENTION

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.

Interventions

Fitbit BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lancaster General Hospital: lead
• Louise von Hess Medical Research Institute: collaborator

Study Sites (1)

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Ku, MD

  Lancaster General Bariatric Surgery and Healthy Weight Management Programs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 6, 2015
• Study Start: October 1, 2015
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)