Type II Diabetes MellitusNCT02761018
Using Technology to Share Fitness Goals and Results to Improve Diabetes Outcomes
A study testing Behavioral: Fitness Tracker and Fitness Tracker in people with Type II Diabetes Mellitus, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- Behavioral: Fitness Tracker and Fitness Tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2017to 2 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
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.
Read the 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)
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Behavioral: Fitness Tracker, Fitness Tracker
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Fitness TrackerBehavioural
will use a fitness tracker but will not be able to see other participant's data
Fitness TrackerBehavioural
will use a fitness tracker and will be able to see other member's daily and weekly results
| Study group | Role | What they receive |
|---|---|---|
| Fitness Tracker | Experimental | will use a fitness tracker but will not be able to see other participant's data Receives: Behavioral: Fitness Tracker |
| Fitness Tracker with Group Participation | Experimental | will use a fitness tracker and will be able to see other member's daily and weekly results Receives: Behavioral: Behavioral: Fitness Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in hemoglobin a1c
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start8 Aug 2017
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David Carlsen, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761018
- Sponsor's protocol ID
- FWH20160062H
- Status last verified
- Sep 2024
- First submitted
- 2 May 2016
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we do not plan on sharing data
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technology to Share Fitness Goals and Results to Improve Diabetes Outcomes
- ClinicalTrials.gov ID
- NCT02761018
- Acronym / sponsor ID
- FWH20160062H
- Conditions
- Type II Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitness Tracker | Experimental | Behavioral: Fitness Trackerwill use a fitness tracker but will not be able to see other participant's data |
| Fitness Tracker with Group Participation | Experimental | Behavioral: Behavioral: Fitness Trackerwill use a fitness tracker and will be able to see other member's daily and weekly results |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Fitness Trackerwill use a fitness tracker but will not be able to see other participant's data | Behavioural | Fitness Tracker with Group Participation |
| Fitness Trackerwill use a fitness tracker and will be able to see other member's daily and weekly results | Behavioural | Fitness Tracker |
Primary outcome
Reduction in hemoglobin a1c
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. we do not plan on sharing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Carlsen, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Fitness Tracker and Fitness Tracker in people with Type II Diabetes Mellitus, run by Mike O'Callaghan Military Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in hemoglobin a1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.