Strategies to Improve Well-Being and Diabetes Management

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Strategies to Improve Well-Being and Diabetes Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348238
• Other study ID #: 2074997
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: March 2024
• Source: MaineHealth
• Contact: Elizabeth Scharnetzki
• Phone: 8053409716
• Email: elizabeth.scharnetzki[@]mainehealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 28, 2027
• Est. primary completion date: March 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Individuals under 18 years of age

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research	Westbrook	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Scharnetzki	MaineHealth Institute for Research

Country where clinical trial is conducted

United States, 

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* Note: There are 61 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Identity Threat Concerns (SITC) Scale	Used to assess participants' concerns about experiencing 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
Primary	Two-Factor Weight Bias Internalization Scale	6-item subscale measure assessing weight-related self-devaluation. . 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 weight bias internalization.	Immediately after each intervention; completed 4 times over the course of a year
Primary	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
Primary	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
Primary	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
Primary	Blood glucose	Continuous glucose monitor derived indices for time spent in-range	Through study completion, an average of 1 year
Secondary	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
Secondary	Patient-reported age	Patient's self-reported age in years	Collected once at time of study enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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