Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Observational
SUMMARY

The goal of this observational study is to evaluate the feasibility and acceptability of a 12-week intervention utilizing a Fitbit and artificial intelligence (AI)-delivered diabetes self-management education and support (DSMES) with tailored text messages. The main question it aims to answer is: Does providing a wearable fitness and activity tracker plus AI-tailored and DSMES improve clinical outcomes for patients with type 2 diabetes? Participants will complete a baseline visit, wear a Fitbit and answer text messages for 12-weeks, and complete by a final visit.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Diagnosed with type 2 diabetes per investigator discretion

• No more than 20% of the sample will have A1c \< 7.5% (confirmed by medical record review or an A1c completed within 3 months of the screening visit)

• Age ≥18 years and ≤ 80 years

• Does not meet ADA guidelines for physical activity (\< 150 minutes of aerobic exercise per week defined as any activity where the participant can talk but not sing)

• Has a smartphone compatible with a Fitbit

Locations
United States
Colorado
University of Colorado, Anschutz
RECRUITING
Aurora
Contact Information
Primary
Jessica Parascando, MPH
jessica.parascando@cuanschutz.edu
303-724-9525
Backup
Elizabeth Westfeldt, BSN, RN
elizabeth.westfeldt@cuanschutz.edu
Time Frame
Start Date: 2025-09-03
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 36
Treatments
Experimental: Fitbit and AI Chatbot
Participants will wear their Fitbit devices daily and receive personalized messages from the AI Chatbot weekly with setting a new exercise goal based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support, education, and goal setting. Participants will interact throughout the week on completing their goal or where they might improve.
Active Comparator: Controls
The control group will be established through a rigorous retrospective chart review of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention.
Related Therapeutic Areas
Sponsors
Collaborators: American Academy of Family Physicians
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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