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

NCT02761018 | Completed

• 1 other identifier: FWH20160062H
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Reduction in hemoglobin a1c

  6 months

Study Arms (2)

Fitness Tracker

EXPERIMENTAL

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

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

Behavioral: Behavioral: Fitness Tracker

Interventions

Behavioral: Fitness Tracker BEHAVIORAL

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

Fitness Tracker with Group Participation

Fitness Tracker BEHAVIORAL

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

Fitness Tracker

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• David Carlsen, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 4, 2016
• Study Start: August 8, 2017
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)