Improving Diabetes in Emerging Adulthood

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Wayne State University
Study ID
NCT04066959
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Motivational Enhancement System (MES) — BEHAVIORAL
    MES is a brief eHealth intervention delivered via an internet-based software application. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. The goal of MES is to increase motivation to complete daily diabetes care tasks. MES consists of two 20-minute sessions that integrate psychoeducation with motivation-enhancing therapeutic exercises and behavioral goal setting.
  • Question Prompt List (QPL) — BEHAVIORAL
    A QPL is a list of questions related to the physical and psychosocial aspects of diabetes and treatment that youth may want to ask their physicians during a clinic visit. The theoretical foundation for the QPL resides in social-cognitive theory which posits that behavioral performance is a function of self-efficacy and behavioral expectations. Thus, the goal of a QPL is to increase self-efficacy and active participation in clinical care. QPL is completed within 14-days of a diabetes clinic visit and results in a personalized set of questions for youth to bring to their clinic visit.
  • Text Message Reminders (TXT) — BEHAVIORAL
    TXT is a behavioral support strategy composed of one-way text message reminders to promote daily diabetes care task completion. TXT is supported by social cognitive theory which suggests that consistent task completion leads to perceptions of control and supports goal attainment. TXT may also foster a stronger relationship with diabetes care providers through greater communication and satisfaction. Youth will receive daily reminders to complete key diabetes care tasks.

Study Details

This project will test the efficacy of a multi-component behavioral intervention to improve metabolic control among older adolescents and emerging adults (16-21) with T1D, a group with chronic poor metabolic control. This intervention is grounded in self-determination theory which states that a youth who believes their diabetes management is self-directed, competent, and supported by others is more likely to consistently complete their diabetes self-care. This theory-driven intervention will be scalable to a variety of chronic illness contexts and the knowledge gained from this research will inform self-determination theory and different interventions targeting this population (currently there are no interventions that directly target emerging adults).

Key Dates

Start date
Nov 16, 2020
Status verified
Apr 2026
Primary completion
Jan 13, 2025
Completion
Jan 13, 2025

Study Design

Enrollment
113 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Question Prompt List (QPL)
    A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.
  • Experimental: Motivation Enhancement System (MES)
    MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.
  • Experimental: Text Message Reminders (TXT)
    Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.
  • Experimental: QPL & MES
    Participants will receive the QPL and MES interventions as described above.
  • Experimental: QPL & TXT
    Participants will receive the QPL and TXT interventions as described above.
  • Experimental: MES & TXT
    Participants will receive the MES and TXT interventions as described above.
  • Experimental: MES, QPL & TXT
    Participants will receive the MES, QPL, and TXT interventions as described above.
  • No Intervention: Standard Medical Care
    Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.

Primary Outcome Measure

Hemoglobin A1c [ Time Frame: Baseline/0 month, Treatment End/3 months, and Follow Up/6 months ]

Locations (1)

FacilityCityStateZIP
Detroit Medical CenterDetroitMichigan48201

Find similar trials in Detroit, MI

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Detroit Medical Center· Detroit, MI

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