Strategies to Improve Well-Being and Diabetes Management

NCT06348238 | Recruiting

• 1 other identifier: 2074997
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (7)

• 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

  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

• 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

• 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

Secondary Outcomes (19)

• Hemoglobin A1C

  Collected once at time of study enrollment and once at study completion

• Patient-reported age

  at end of study (1 year)

• Patient Gender

  Collected once at time of study enrollment

• Patient Race

  Collected once at time of study enrollment

• Patient ethnicity

  Collected once at time of study enrollment

Study Arms (2)

Self-Affirmation

EXPERIMENTAL

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

Waitlist Control

SHAM COMPARATOR

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

Interventions

Self-Affirmation BEHAVIORAL

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.

Self-Affirmation; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Individuals under 18 years of age

Sponsors & Collaborators

• Elizabeth Scharnetzki: lead
• MaineHealth: collaborator

Study Sites (1)

MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research

Westbrook, Maine, 04092, United States

RECRUITING

Related Publications (61)

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  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elizabeth Scharnetzki

  MaineHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Scharnetzki

CONTACT

8053409716; elizabeth.scharnetzki@mainehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are masked to their assigned condition until the end of the study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty Scientist I

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: April 4, 2024
• Study Start: July 24, 2024
• Primary Completion: March 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Upon completion of data collection and throughout the publication and dissemination period.

Locations

US (1)