Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 8, 2020
Date Accepted: Aug 25, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy
ABSTRACT
Poor diabetes self-management in emerging adulthood, the unique developmental period between adolescence and adulthood (age 18-25), is associated with poorer diabetes health and diabetes complications. Emerging adults’ focus on individuation and independence is an underlying reason for their poor diabetes outcomes that offers a lever for behavior change. Self-determination theory suggests that interventions leveraging emerging adults’ innate developmental need for autonomy may offer a route to improving diabetes outcomes by increasing feelings of responsibility for and control over diabetes self-management activities. This research project will use the multiphase optimization strategy (MOST) to test the efficacy of three autonomy supportive intervention components to elicit a clinically significant improvement in metabolic control, as assessed by a 0.5% improvement in hemoglobin A1c, among older adolescents and emerging adults (16-25 years) with poorly controlled (HbA1c ≥9.0%) type 1 diabetes. The first, a question prompt list, is a tool to empower patients to assume a more active role during medical visits by asking questions and stating concerns. The second component, the motivation enhancement system, is a brief counseling intervention that uses Motivational Interviewing communication strategies to build intrinsic motivation and self-efficacy for self-management. Component three is text message reminders to complete diabetes care tasks which may increase self-efficacy for diabetes self-management. After refining these intervention components for emerging adults, we will conduct a component selection experiment using an eight-arm full factorial design: 2 (QPL yes or no) X 2 (MES yes or no) X 2 (TXT yes or no). Participants will complete three study visits, baseline, 3- and 6-month follow up, with intervention components delivered in the period between the baseline and 3-month study visits. The primary outcome is metabolic control, which will be measured via hemoglobin A1c (HbA1c). Secondary outcomes include diabetes management and diabetes clinic attendance. Self-Determination Theory constructs of intrinsic motivation, self-efficacy, and the quality of the patient-provider relationship (i.e., relatedness) are hypothesized mediators. Depression symptoms and emerging adults’ gender are hypothesized moderators. We will use the mixed effects linear model for the ANOVA of a factorial design to analyze continuous longitudinal experimental data; the generalized linear model will be used with categorial outcomes (e.g., treatment attendance). The experiment was powered to detect intervention main effects on the primary outcome. At the end of this experiment, we will have empirical evidence to support a large scale, multi-site effectiveness trial of an intervention package that has been optimized for older adolescents and emerging adults with poorly controlled type 1 diabetes.
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