protocolSection identificationModule nctId: NCT06348238, orgStudyIdInfo id: 2074997, briefTitle: Strategies to Improve Well-Being and Diabetes Management, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Elizabeth Scharnetzki, class: OTHER, collaborators name: MaineHealth Institute for Research, descriptionModule briefSummary: This project aims to implement an adapted self-affirmation intervention among a population of individuals with diabetes to reduce the negative psychosocial impacts of stigma. In a self-affirmation, participants are guiding through a writing exercise writing designed to reinforce sources of self-worth before they encounter or engage in stressful or stigmatizing events. Participants in this study will be asked to complete self-affirmation exercises before their 3-month wellness appointments with their endocrinologists over the course of a year. The main questions the investigators are asking are:* Will self-affirmation reduce feelings of stigmatization?* Will self-affirmation increase self-efficacy and motivation to engage in condition management behaviors.* Will self-affirmation improve blood glucose control. Participants will be randomly assigned to either the intervention condition or a waitlist control condition. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it.After each appointment and self-affirmation, participants will complete surveys assessing feelings of stigma and motivation to engage in condition management. All participants will already be using continuous glucose monitors. The investigators will compare both survey responses and continuous glucose data between our conditions to assess the efficacy of the self-affirmation intervention., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Self-Affirmation, outcomesModule primaryOutcomes measure: Social Identity Threat Concerns (SITC) Scale, primaryOutcomes measure: Two-Factor Weight Bias Internalization Scale, primaryOutcomes measure: Diabetes Stigma Assessment Scale, primaryOutcomes measure: The Revised Diabetes Self-Management Questionnaire, primaryOutcomes measure: Confidence in Diabetes Self-Care Scale, primaryOutcomes measure: Blood glucose, secondaryOutcomes measure: Hemoglobin A1C, secondaryOutcomes measure: Patient-reported age, secondaryOutcomes measure: Patient Gender, secondaryOutcomes measure: Patient Race, secondaryOutcomes measure: Patient ethnicity, secondaryOutcomes measure: Patient's highest level of education completed, secondaryOutcomes measure: Household income, secondaryOutcomes measure: Zip code, secondaryOutcomes measure: Years since diagnosis, secondaryOutcomes measure: Diabetes Management Plan, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Continuous glucose monitor use, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: History of weight-based victimization (moderator/covariate), secondaryOutcomes measure: Problem Areas in Diabetes Questionnaire (moderator/covariate), secondaryOutcomes measure: Generalized Anxiety Disorder 7-item (moderator/covariate), secondaryOutcomes measure: Patient Health Questionnaire (PHQ-9) (moderator/covariate), secondaryOutcomes measure: Stigma Consciousness Questionnaire (moderator/covariate), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research, city: Westbrook, state: Maine, zip: 04092, country: United States, contacts name: Elizabeth Scharnetzki, role: CONTACT, phone: 805-340-9716, email: elizabeth.scharnetzki@mainehealth.org, geoPoint lat: 43.67703, lon: -70.37116, hasResults: False