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

November 26, 2018 updated by: Mike O'Callaghan Military Hospital
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.

Study Overview

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)

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nevada
      • Nellis Air Force Base, Nevada, United States, 89191
        • Mike O'Callaghan Federal Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fitness Tracker
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
Experimental: Fitness Tracker with Group Participation
will use a fitness tracker and will be able to see other member's daily and weekly results
will use a fitness tracker but will not be able to see other participant's data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in hemoglobin a1c
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David Carlsen, MD, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2017

Primary Completion (Actual)

October 2, 2018

Study Completion (Actual)

October 2, 2018

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

we do not plan on sharing data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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