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      Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy


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          Poor diabetes self-management in emerging adulthood (age 18-25 years) is associated with poorer diabetes health and diabetes complications. Emerging adults’ focus on individuation and independence underlies their poor diabetes outcomes, offering a lever for behavior change. Self-determination theory (SDT) 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 to test the efficacy of three autonomy-supportive intervention components to elicit a clinically significant improvement in metabolic control, assessed by a 0.5% improvement in hemoglobin A 1c (HbA 1c), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA 1c≥9.0%).


          A question prompt list (QPL) is a tool to empower patients to assume a more active role during medical visits by asking questions and stating concerns. The motivation enhancement system (MES) is a brief counseling intervention that uses motivational interviewing communication strategies to build intrinsic motivation and self-efficacy for self-management. Text message reminders to complete diabetes care tasks 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)×2 (MES yes or no)×2 (Text yes or no). Participants will complete 3 study visits: baseline, treatment end at 2 months, and a follow-up at 6 months. The primary outcome is metabolic control, which will be measured via HbA 1c. Secondary outcomes include diabetes management and diabetes clinic attendance. SDT constructs of intrinsic motivation, self-efficacy, and the quality of the patient-provider relationship (ie, relatedness) are hypothesized mediators. Depression symptoms and emerging adults’ gender are hypothesized moderators. We will use the mixed-effects linear model for the analysis of variance of a factorial design to analyze continuous longitudinal experimental data; the generalized linear model will be used with categorical outcomes (eg, treatment attendance). The experiment was powered to detect the main effects of the intervention on the primary outcome.


          A total of 20 participants have enrolled and completed a qualitative interview after reviewing one or more intervention components. Analysis of interview data are underway, with a report of these results anticipated in the fall of 2020. The clinical trial will be launched in the fall 2020, with participants enrolled through May 2023 and data collection continuing through November 2023.


          At the end of this experiment, we will have empirical evidence to support a large-scale, multisite effectiveness trial of an intervention package that has been optimized for older adolescents and emerging adults with poorly controlled T1D.

          Trial Registration

          ClinicalTrials.gov NCT04066959; https://clinicaltrials.gov/ct2/show/NCT04066959

          International Registered Report Identifier (IRRID)


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          Most cited references106

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          The CES-D Scale: A Self-Report Depression Scale for Research in the General Population

          L Radloff (1977)
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            Using the framework method for the analysis of qualitative data in multi-disciplinary health research

            Background The Framework Method is becoming an increasingly popular approach to the management and analysis of qualitative data in health research. However, there is confusion about its potential application and limitations. Discussion The article discusses when it is appropriate to adopt the Framework Method and explains the procedure for using it in multi-disciplinary health research teams, or those that involve clinicians, patients and lay people. The stages of the method are illustrated using examples from a published study. Summary Used effectively, with the leadership of an experienced qualitative researcher, the Framework Method is a systematic and flexible approach to analysing qualitative data and is appropriate for use in research teams even where not all members have previous experience of conducting qualitative research.
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              Intrinsic Motivation and Self-Determination in Human Behavior


                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                October 2020
                20 October 2020
                : 9
                : 10
                : e20191
                [1 ] Department of Family Medicine and Public Health Sciences School of Medicine Wayne State University Detroit, MI United States
                [2 ] Population Studies and Disparities Research Program Karmanos Cancer Institute Wayne State University Detroit, MI United States
                [3 ] Department of Pediatrics School of Medicine Wayne State University Detroit, MI United States
                [4 ] Division of Public Health Department of Obstetrics, Gynecology, and Reproductive Biology Michigan State University East Lansing, MI United States
                Author notes
                Corresponding Author: April Idalski Carcone acarcone@ 123456med.wayne.edu
                Author information
                ©April Idalski Carcone, Deborah A Ellis, Susan Eggly, Karen E MacDonell, Samiran Ghosh, Colleen Buggs-Saxton, Steven J Ondersma. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 20.10.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 8 June 2020
                : 27 June 2020
                : 21 August 2020
                : 25 August 2020

                emerging adults,type 1 diabetes,self-determination theory,motivational interviewing


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