Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348238
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-03-04
Brief Title:
Strategies to Improve Well-Being and Diabetes Management
Sponsor:
Elizabeth Scharnetzki
Organization:
MaineHealth
Study Overview
Official Title:
Strategies to Improve Well-Being and Diabetes Management
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None