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Improving Diabetes in Emerging Adulthood

Improving Diabetes Health in Emerging Adulthood Through an Autonomy Supportive Intervention

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04066959
Acronym
IDEA
Enrollment
113
Registered
2019-08-26
Start date
2020-11-16
Completion date
2025-01-13
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

emerging adults, ehealth intervention, diabetes, diabetes management, adolescents, self-determination theory

Brief summary

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).

Detailed description

This project will use the multiphase optimization strategy (MOST) approach to test the efficacy of an autonomy supportive behavioral intervention to improve metabolic control among older adolescents and emerging adults (16-25) with T1D. Youth this age demonstrate chronic poor metabolic control that persists into adulthood leading to the premature emergence of short- and long-term diabetes complications. Developmentally, adolescence and emerging adulthood is a time when the need for independence and autonomy are particularly salient. This new intervention will leverage youths' desire for autonomy by designing an intervention to support diabetes self-management autonomy. This intervention is guided by self-determination theory (SDT) which suggests that autonomous (i.e., self-initiated, driven by intrinsic versus extrinsic motivation) diabetes management depends upon three conditions: 1) the perception that one's behavior is self-directed, 2) feelings of competence, or self-efficacy, and 3) the existence of caring relationships supportive of the behavior. The investigators have identified three intervention components that target the SDT constructs. A question prompt list (QPL) is a simple, inexpensive tool comprised of a list of questions that patients might consider asking their health care provider during a clinic visit. QPLs empower patients to assume a more active role (asking questions and stating concerns) during clinic visits. The Motivation Enhancing System (MES) is an eHealth intervention to increase intrinsic motivation for health behavior change. MES content is based on the Motivational Interviewing (MI) framework and the Information-Motivation-Behavioral Skills (IMB) model of health behavior change which posits that behavior change results from the joint function of three critical components: accurate information about risk behaviors or their replacement health behaviors, motivation to change behavior, and behavioral skills necessary to perform the behavior (self-efficacy). Text message reminders (TXT) are a strategy to encourage youth to complete their diabetes self-care that also lead to gains in self-efficacy and a stronger relationship with diabetes care providers through greater communication and satisfaction. The investigators will test the efficacy of these intervention components toward improving metabolic control in a component selection experiment (N=320). The experiment will use a full factorial research design with random assignment to determine which intervention components contribute to a clinically significant improvement (≥0.5%) in HbA1c. The result of this research will be an optimized, multi-component intervention with effect size estimates that will be used to inform a large scale, fully powered effectiveness trial. 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 behavioral interventions targeting this population (for which there currently are none).

Interventions

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.

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.

BEHAVIORALText Message Reminders (TXT)

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.

Sponsors

Wayne State University
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcomes assessor/data collector will be kept blind to treatment assignments to the extent possible in a behavioral trial.

Intervention model description

The study will use an 8-arm full factorial design. In arms 1-3 participants will receive 1 of the 3 intervention components, arms 4-6 receive a combination of 2 components, arm 7 receives all 3 components, and arm 8 is the standard care control. The study will use the mixed effects linear model for the ANOVA of a factorial design powered on the main effects to identify the intervention components that significantly contribute to a clinically significant improvement in HbA1c. Each model will include a random intercept and slope and fixed effects for treatment combinations and time, as well as the stratification variable. The component selection experiment will result in empirical evidence supporting the efficacy of an autonomy support intervention composed of one or more components to improve metabolic control.

Eligibility

Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

Inclusion: 1. Age 16 years, 0 months - 25 years, 11 months 2. Type 1 diabetes (T1D) 3. HbA1c ≥7.5% currently and averaged over the previous 6 months 4. Duration of diabetes ≥6 months 5. English fluency, both verbal and written 6. Cell phone access with texting capability Exclusion: 7. Psychosis (e.g., schizophrenia or bipolar disorder) 8. Suicidal 9. Developmental delay (moderate or severe mental retardation, or autism) or reading level below sixth grade 10. The presence of another physical health condition that results in atypical diabetes management (e.g., cystic fibrosis)

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1cBaseline/0 month, Treatment End/3 months, and Follow Up/6 monthsHb1Ac will be obtained by using the Accubase A1c test kit.

Secondary

MeasureTime frameDescription
Diabetes Management ScaleBaseline/0 month, Treatment End/3 months, and Follow Up/6 monthsThe Diabetes Management Scale (DMS) is a self-report measure of diabetes illness management assessing a broad range of diabetes management behaviors, including insulin management, dietary management, blood glucose monitoring, and symptom response with good internal consistency (α=.74 to .84). Ten items ask "What percent of the time do you (diabetes care task)?" with a response scale of 0-100% where higher scores indicate greater (better) diabetes management. A total score, ranging form 0-100%, is obtained by calculating the average response across ten items to reflect overall management behavior.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORApril Carcone, PhD

Wayne State University

Participant flow

Recruitment details

Recruitment into the clinical trial began on 11/16/2020 and ended 07/31/2024. The primary recruitment locations were local endocrinology clinics and advertising with national (e.g., T1D Exchange) and local (e.g., universities) community-based organizations and social media.

Pre-assignment details

The participant enrollment process consisted of informed consent/assent procedures, baseline data collection, and randomization to one of eight study arms. Of the 113 enrolled participants, 109 were randomized and 4 were not: 1 found to be ineligible (age) post-enrollment and 3 were never randomized due to research staff error.

Baseline characteristics

Characteristic
Age, Continuous21.9 years
STANDARD_DEVIATION 2.6
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
60 Participants
Sex/Gender, Customized
Participant-described Gender Identity
Female
7 Participants
Sex/Gender, Customized
Participant-described Gender Identity
Male
7 Participants
Sex/Gender, Customized
Participant-described Gender Identity
Nonbinary
0 Participants
Sex/Gender, Customized
Participant-described Gender Identity
Transgender
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 100 / 160 / 120 / 140 / 170 / 110 / 14
other
Total, other adverse events
3 / 153 / 107 / 162 / 123 / 147 / 176 / 115 / 14
serious
Total, serious adverse events
3 / 155 / 105 / 163 / 122 / 146 / 174 / 114 / 14

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026