Strategies to Improve Well-Being and Diabetes Management

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Self-Affirmation

Detailed Description

Upon enrollment, participants will receive an electronic link to an enrollment survey to assess their baseline perceptions of diabetes and weight-based stigma, attitudes towards and intentions to engage in condition management behaviors, sociodemographic and clinical factors (e.g., gender, age, race, and ethnicity) and potential moderators, including diabetes distress, anxiety, depression, history of weight-based victimization, and stigma consciousness. Participants will then be randomly assigned to either the self-affirmation intervention or a waitlist control condition (participants in the waitlist control will have the option to receive the same intervention as participants in the experimental condition at end of the study period). Participants will be using the randomization module in our online survey vendor, REDCap. This module allows researchers to program REDcap to automatically randomize participants in their study to one of the arms or conditions of their study. Before every 3-month wellness visit with their endocrinologist, participants will receive an electronic prompt to complete a self-affirmation writing induction. To complete the writing induction, participants will review a list of values and are instructed to choose up to two that are important to them. Next, participants are asked to write a few sentences about why their chosen values are important to them and identify times in which these values have helped them navigate challenges. 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 their 3-month wellness visit, participants will be sent an electronic link to the post-intervention survey. This will assess to assess their baseline perceptions of diabetes and weight-based stigma, attitudes towards and intentions to engage in condition management behaviors. In total, participants will complete 4 writing inductions and 4 post-evaluation surveys over the course of a year. In addition to writing inductions and survey data, aggregated data from participants' continuous glucose monitors will be collected throughout the study period to assess time spend in target glucose range. The investigators will also collect participants' most recent pre-and-post intervention Hemoglobin A1C (HbA1c) measurements via EHR data to assess longitudinal changes in glucose control. To evaluate the effectiveness of our intervention, the investigators will test whether mean scores in 1) post-intervention stigma and stigma-induced identity threat scores; 2) average confidence in and intentions to engage in condition management scores; and 3) average time spent in target glycemic target range significantly differ between conditions.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Scharnetzki; Phone Number: 8053409716; Email: elizabeth.scharnetzki@mainehealth.org

Study Locations

• United States
  • Maine
    • Westbrook, Maine, United States, 04092
      • Recruiting
      • MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research
      • Contact: Elizabeth Scharnetzki; Phone Number: 805-340-9716; Email: elizabeth.scharnetzki@mainehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must be at least 18 years of age, have a type 2 diabetes (T2D) diagnosis, and currently use a continue glucose monitor as part of their condition management.
• Participants must be patients of MaineHealth Endocrinology and Diabetes, be at least 18 years of age, have a type 2 diabetes (T2D) diagnosis, and currently use a continue glucose monitor as part of their condition management (Dexcom, FreeStyle Libre).

Exclusion Criteria:

• Individuals under 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-Affirmation; Participants review a list of values and are instructed to choose up to two that are important to them. The values listed are intentionally unrelated to the threat-inducing domain so that the exercise broadens participants' focus. Next, participants are asked to write a few sentences about why their chosen values are important to them and identify times in which these values have helped them navigate challenges.	Behavioral: Self-Affirmation; Self-affirmation theory contends that integrity of one's self-concept (self integrity) is essential for navigating daily stressors. When individuals encounter information or contexts that pose a threat to one's self-integrity, we can adopt maladaptive coping strategies to alleviate the discomfort. One strategy for strengthening self-integrity is engage in an explicit process of reinforcing sources of self-worth - self-affirmation. Self affirmation interventions have participants engage in an exercise writing about core personal values (a writing induction). In a writing induction, participants review a list of values and are instructed to choose up to two that are important to them. Participants are then asked to write a few sentences about why their chosen values are important to them and identify times in which these values have helped them navigate challenges.
Sham Comparator: Waitlist Control; 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.	Behavioral: Self-Affirmation; Self-affirmation theory contends that integrity of one's self-concept (self integrity) is essential for navigating daily stressors. When individuals encounter information or contexts that pose a threat to one's self-integrity, we can adopt maladaptive coping strategies to alleviate the discomfort. One strategy for strengthening self-integrity is engage in an explicit process of reinforcing sources of self-worth - self-affirmation. Self affirmation interventions have participants engage in an exercise writing about core personal values (a writing induction). In a writing induction, participants review a list of values and are instructed to choose up to two that are important to them. Participants are then asked to write a few sentences about why their chosen values are important to them and identify times in which these values have helped them navigate challenges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Stigma Assessment Scale	6-item subscale assessing participants perceived and experienced stigma for use with adults with diabetes. A 1(strongly disagree) to 5 (strongly agree) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater diabetes stigma.	Immediately after each intervention; completed 4 times over the course of a year
The Revised Diabetes Self-Management Questionnaire	27-items measure to assess uptake of essential self-management practices for Diabetes. A 0 (Does not apply to me) to 3 (Applies to me very much) Likert response scale is used for all items.	Immediately after each intervention; completed 4 times over the course of a year
Confidence in Diabetes Self-Care Scale	20-item measure assessing patient self-efficacy, confidence in ability to perform diabetes self-care tasks. A 1 ("No, I am sure I cannot") to 5 ("Yes, I am sure I can") Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater confidence.	Immediately after each intervention; completed 4 times over the course of a year
Blood glucose	Continuous glucose monitor derived indices for time spent in-range	Through study completion, an average of 1 year
Social Identity Threat Concerns (SITC) Scale - Adapted for Diabetes	Used to assess participants' concerns about experiencing diabetes-specific stigma-induced identity threat while receiving care for T2D. A 1 (Strongly disagree) to 7 (Strongly agree) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater social identity threat concerns.	Immediately after each intervention; completed 4 times over the course of a year
Social Identity Threat Concerns (SITC) Scale - Adapted for Weight	Used to assess participants' concerns about experiencing weight-specific stigma-induced identity threat while receiving care for T2D. A 1 (Strongly disagree) to 7 (Strongly agree) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater social identity threat concerns.	Immediately after each intervention; completed 4 times over the course of a year
Diabetes Stigma Assessment Scale - Adapted for weight stigma	6-item subscale assessing participants perceived and experienced stigma for use with adults with diabetes. We adapted this measure to anchor on internalized weight stigma. A 1(strongly disagree) to 5 (strongly agree) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater diabetes stigma.	Immediately after each intervention; completed 4 times over the course of a year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C	Blood assay assessing average blood glucose level; Will be collected as part of EPIC data requests; HbA1c will be requested at the time of study enrollment and throughout study completion (5 total)	Collected once at time of study enrollment and once at study completion
Patient Gender	Patient's self-reported gender identity; They may select as many as apply from the following: Man, Woman, Transgender, Gender Queer/Gender non-conforming, Non-Binary, Different Identity (Please specify), Prefer not to answer	Collected once at time of study enrollment
Patient Race	Patient's self-reported racial identity. They may select as many as apply from the following: White, Black, Asian, Native American or Alaska Native, Middle Eastern or North African, Native Hawaiian or other Pacific Islander Different Identity(Please specify) Prefer not to answer	Collected once at time of study enrollment
Patient ethnicity	Patient's self-reported ethnicity: Are you of Hispanic, Latino or Spanish origin, such as Mexican, Puerto Rican, or Cuban? Yes, No, Prefer not to answer	Collected once at time of study enrollment
Patient's highest level of education completed	Patient's self-reported highest level of education completed; They may select from: 8th grade or less, Some high school, High school diploma/GED, Some college or technical school classes, no degree, Associate's or Bachelor's degree, Master's, doctorate, or professional degree, Prefer not to answer	Collected once at time of study enrollment
Household income	Patient's self-reported household income: Which of the following categories best describes the total income for the household where you live?; Less than $20,000; Between $20,000 and $70,000; More than $70,000; Don't know/Not sure; Prefer not to answer	Collected once at time of study enrollment
Zip code	Patients will be asked to provide a value for the following question: What is the zip code for the area where you currently live? Zip codes will be converted to Rural-Urban Commuting Area Codes, which are used to classify census tracts into rural and urban categories.	Collected once at time of study enrollment
Years since diagnosis	Patients' will provide a value for the following question: How many years has it been since you were first diagnosed with Type 2 Diabetes? Diabetes diagnosis and year of diabetes diagnosis will also be verified as part of an EPIC data request	Collected once at time of study enrollment
Diabetes Management Plan	Patients' will provide a value for the following question: Which of the following options best describes how you manage your Type 2 Diabetes?; Diet; Medication; Both diet and medication If Medication or Both diet and medication is selected: Please tell us more about medications and medication dosages you are currently taking to manage your diabetes: ______________________	Collected once at time of study enrollment
Physical activity	Patients' will provide text responses for the following questions: What kind of physical activity do you do? How often do you do this activity (days per week) How long do you typically do this activity for (minutes)	Collected once at time of study enrollment
Continuous glucose monitor use	Patients' will provide a value for the following question: How long have you been using your continuous glucose monitor (in months or years)?	Collected once at time of study enrollment
Height	Patient's height (feet and inches) will be collected as part of an EPIC data request; this will be used to calculate BMI	Collected once at time of study enrollment
Weight	Patient's weight (pounds) will be collected as part of an EPIC data request; this will be used to calculate BMI	Collected once at time of study enrollment
History of weight-based victimization (moderator/covariate)	3-item measure assessing experiences of weight-based discrimination. A binary Yes/No response scale is used for all items. The number of affirmative responses will be summed to create a composite. Higher scores indicate greater weight-based victimization.	Collected once at time of study enrollment
Problem Areas in Diabetes Questionnaire (moderator/covariate)	20-item measure of diabetes-related emotional distress that assesses a broad range of feelings related to living with diabetes. A 0 (Not a problem) to 4 (Serious problem) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater distress.	Collected once at time of study enrollment
Generalized Anxiety Disorder 7-item (moderator/covariate)	7-item measure of generalized anxiety disorder. A 0 (Not at all) to 3 (Nearly every day) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater anxiety.	Collected once at time of study enrollment
Patient Health Questionnaire (PHQ-9) (moderator/covariate)	9-item measure of depression severity. A 0 (Not at all) to 3 (Nearly every day) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater depression.	Collected once at time of study enrollment
Stigma Consciousness Questionnaire (moderator/covariate)	10-item measure to predict the degree to which stigmatized groups expect to be stereotyped and discriminated against by others. These items will be adapted to measure stigma consciousness relating to diabetes and health care. A 0 (strongly disagree) to 6(strongly agree) Likert scale, with a midpoint of 3 (neither agree nor disagree) is used for all items. A composite score is created by summing all items. Higher values indicate greater stigma consciousness.	Collected once at time of study enrollment
Patient-reported age	Patient's self-reported age in years	at end of study (1 year)

Collaborators and Investigators

• Sponsor: Elizabeth Scharnetzki
• Collaborators: MaineHealth
• Investigators: Principal Investigator: Elizabeth Scharnetzki, MaineHealth

Publications and helpful links

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• Liu NF, Brown AS, Folias AE, Younge MF, Guzman SJ, Close KL, Wood R. Stigma in People With Type 1 or Type 2 Diabetes. Clin Diabetes. 2017 Jan;35(1):27-34. doi: 10.2337/cd16-0020.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Estimated): March 28, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2074997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Our findings will be shared with the science and local communities through scientific publications and professional conference presentations. To ensure study findings are reproduceable, per best practice, statistical code for our analyses will be made available on open science platforms (e.g., Open Science Framework), and deidentified, aggregated data may be available upon request by members of the scientific community. All findings will be reported at the group-level, so nothing can be tied to participants as individuals.
• IPD Sharing Time Frame: Upon completion of data collection and throughout the publication and dissemination period.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No