Clinical trial NCT06348238: Strategies to Improve Well-Being and Diabetes Management
Official title: Strategies to Improve Well-Being and Diabetes Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: MaineHealth
First posted: 2024-04-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Social Identity Threat Concerns (SITC) Scale - Adapted for Diabetes
timeFrame: Immediately after each intervention; completed 4 times over the course of a year
measure: Social Identity Threat Concerns (SITC) Scale - Adapted for Weight
timeFrame: Immediately after each intervention; completed 4 times over the course of a year
measure: Diabetes Stigma Assessment Scale
timeFrame: Immediately after each intervention; completed 4 times over the course of a year
measure: Diabetes Stigma Assessment Scale - Adapted for weight stigma
timeFrame: Immediately after each intervention; completed 4 times over the course of a year
measure: The Revised Diabetes Self-Management Questionnaire
timeFrame: Immediately after each intervention; completed 4 times over the course of a year
measure: Confidence in Diabetes Self-Care Scale
timeFrame: Immediately after each intervention; completed 4 times over the course of a year
measure: Blood glucose
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: Collected once at time of study enrollment and once at study completion
measure: Patient-reported age
timeFrame: at end of study (1 year)
measure: Patient Gender
timeFrame: Collected once at time of study enrollment
measure: Patient Race
timeFrame: Collected once at time of study enrollment
measure: Patient ethnicity
timeFrame: Collected once at time of study enrollment
measure: Patient's highest level of education completed
timeFrame: Collected once at time of study enrollment
measure: Household income
timeFrame: Collected once at time of study enrollment
measure: Zip code
timeFrame: Collected once at time of study enrollment
measure: Years since diagnosis
timeFrame: Collected once at time of study enrollment
measure: Diabetes Management Plan
timeFrame: Collected once at time of study enrollment
measure: Physical activity
timeFrame: Collected once at time of study enrollment
measure: Continuous glucose monitor use
timeFrame: Collected once at time of study enrollment
measure: Height
timeFrame: Collected once at time of study enrollment
measure: Weight
timeFrame: Collected once at time of study enrollment
measure: History of weight-based victimization (moderator/covariate)
timeFrame: Collected once at time of study enrollment
measure: Problem Areas in Diabetes Questionnaire (moderator/covariate)
timeFrame: Collected once at time of study enrollment
measure: Generalized Anxiety Disorder 7-item (moderator/covariate)
timeFrame: Collected once at time of study enrollment
measure: Patient Health Questionnaire (PHQ-9) (moderator/covariate)
timeFrame: Collected once at time of study enrollment
measure: Stigma Consciousness Questionnaire (moderator/covariate)
timeFrame: Collected once at time of study enrollment
Other outcomes:
Locations:
city: Westbrook
country: United States
facility: MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research
state: Maine
Study officials:
affiliation: MaineHealth
name: Elizabeth Scharnetzki
role: PRINCIPAL_INVESTIGATOR
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