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Using Technology to Share Fitness Goals and Results to Improve Diabetes Outcomes

Primary Purpose

Type II Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral: Fitness Tracker
Fitness Tracker
Sponsored by
Mike O'Callaghan Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type II Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

YOU MUST BE ABLE TO GET CARE AT NELLIS AFB (A MILITARY INSTALLATION) IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

  • Male and female DoD beneficiaries, age 18 years or older, who have been diagnosed with Type II Diabetes
  • Ability to set up fitness tracking software on personal computer or cell phone
  • Ability to learn and use personal activity monitor

Exclusion:

  • Male and female DoD beneficiaries, under the age of 18 years
  • Unwilling to share personal fitness results anonymously
  • Inability to do 4 metabolic equivalents of exercise (walk 100feet, walk up flight of stairs etc).
  • Inability to walk without the use of assistive devices (cane is OK)
  • Medical problem which would make walking unsafe (recent surgery, uncontrolled heart condition, fall risk etc).
  • No special populations (e.g., pregnant women, children, prisoners, detainees) will be recruited.

Sites / Locations

  • Mike O'Callaghan Federal Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fitness Tracker

Fitness Tracker with Group Participation

Arm Description

will use a fitness tracker but will not be able to see other participant's data

will use a fitness tracker and will be able to see other member's daily and weekly results

Outcomes

Primary Outcome Measures

Reduction in hemoglobin a1c

Secondary Outcome Measures

Full Information

First Posted
May 2, 2016
Last Updated
November 26, 2018
Sponsor
Mike O'Callaghan Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02761018
Brief Title
Using Technology to Share Fitness Goals and Results to Improve Diabetes Outcomes
Official Title
Using Technology to Share Fitness Goals and Results to Improve Diabetes Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
October 2, 2018 (Actual)
Study Completion Date
October 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mike O'Callaghan Military Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will recruit DoD beneficiaries, aged 18 years or older and diagnosed as being Type II diabetic. Patients will be randomized into one of two groups. Group 1 will use a fitness tracker but will not be able to see other participants data and group 2 will use a fitness tracker and will be able to see other members daily and weekly results. Outcome measures will be assessed at baseline, 3 months and 6 months to include hemoglobin A1c, weight, body mass index, blood pressure, and number of hours and days fitness tracker is used. The goal is to see if the group randomized into an online community will have improved activity and outcome measurements compared with those who use the pedometer alone.
Detailed Description
Male and female DoD beneficiaries ages 18 years or older who have been diagnosed with Type II diabetes, will be recruited at the Mike O'Callaghan Federal Medical Center (MOFMC). Screening Visit: Obtain signed Informed Consent Document and HIPAA Authorization (research-driven). Record: Date of birth, phone number, age, gender, race, ethnicity, social security number, current email address, height (in inches), weight (in pounds), blood pressure, medications list including any over-the-counter and prescription weight loss medication (name, strength, dose) or supplements. Subjects will have the following standard of care blood test drawn which include: Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn) Visit 1 (Day 1 within 1 week of Screening Visit): Record: Weight (in pounds), blood pressure, and any changes to their medications list. Subjects will complete the RAND 36 Item Health Survey. Subjects will complete the Intake Questionnaire. Subjects will be assigned their Fitness Tracker username and their username and password will be recorded by the Research Coordinator. Subjects will be given User Instructions based off of their randomization group. Subjects will be instructed to follow all research procedures and that failure to do so may result in the removal from the study and the return of the Fitness Tracker. Subjects will be randomized by the research coordinator using a random-number generator into one of two groups (research-driven): Group 1: will use a fitness tracker but will not be able to see other participant's data. Group 2: will use a fitness tracker and will be able to see other member's daily and weekly results. Both groups will receive the scripted feedback at set time intervals by the Research Coordinators. Subjects will be provided a fitness tracker and instructed on how to use it. If subject is a DoD beneficiary, and finishes all study-related procedures at month 6, they will keep the fitness tracker. If a subject does not complete all study-related procedures, they will be asked to return the fitness tracker so the investigators can erase their data and re-issue to another study subject. If subject is active duty or a DoD employee, regardless of their study completion, they will be asked to complete Temporary Issue Receipt and bring back the fitness tracker at the end of the study. Visit 2 (Month 3/90 days post Visit 1): Record: Weight (in pounds), blood pressure and any changes to their medications list. Subjects will complete the RAND 36 Item Health Survey. Subjects will complete the Follow up Questionnaire. Obtain information from their fitness tracker. Subjects will have the following standard of care blood test drawn which include: Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn) Final Visit 3 (Month 6/90 days post Visit 2): Record: Weight (in pounds), blood pressure and any changes to their medications list. Subjects will complete the RAND 36 Item Health Survey and be asked some additional questions. Subjects will complete the Follow up Questionnaire. Obtain information from their fitness tracker. Subjects will have the following standard of care blood test drawn which include: Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fitness Tracker
Arm Type
Experimental
Arm Description
will use a fitness tracker but will not be able to see other participant's data
Arm Title
Fitness Tracker with Group Participation
Arm Type
Experimental
Arm Description
will use a fitness tracker and will be able to see other member's daily and weekly results
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Fitness Tracker
Intervention Description
will use a fitness tracker but will not be able to see other participant's data
Intervention Type
Behavioral
Intervention Name(s)
Fitness Tracker
Intervention Description
will use a fitness tracker and will be able to see other member's daily and weekly results
Primary Outcome Measure Information:
Title
Reduction in hemoglobin a1c
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
YOU MUST BE ABLE TO GET CARE AT NELLIS AFB (A MILITARY INSTALLATION) IN ORDER TO PARTICIPATE IN THIS STUDY. Inclusion: Male and female DoD beneficiaries, age 18 years or older, who have been diagnosed with Type II Diabetes Ability to set up fitness tracking software on personal computer or cell phone Ability to learn and use personal activity monitor Exclusion: Male and female DoD beneficiaries, under the age of 18 years Unwilling to share personal fitness results anonymously Inability to do 4 metabolic equivalents of exercise (walk 100feet, walk up flight of stairs etc). Inability to walk without the use of assistive devices (cane is OK) Medical problem which would make walking unsafe (recent surgery, uncontrolled heart condition, fall risk etc). No special populations (e.g., pregnant women, children, prisoners, detainees) will be recruited.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Carlsen, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mike O'Callaghan Federal Medical Center
City
Nellis Air Force Base
State/Province
Nevada
ZIP/Postal Code
89191
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
we do not plan on sharing data

Learn more about this trial

Using Technology to Share Fitness Goals and Results to Improve Diabetes Outcomes

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