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Strategies to Improve Well-Being and Diabetes Management - Trial NCT06348238

Access comprehensive clinical trial information for NCT06348238 through Pure Global AI's free database. This phase not specified trial is sponsored by Elizabeth Scharnetzki and is currently Not yet recruiting. The study focuses on Diabetes Mellitus, Type 2. Target enrollment is 150 participants.

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NCT06348238
Not yet recruiting
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06348238
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Strategies to Improve Well-Being and Diabetes Management

Study Focus

Diabetes Mellitus, Type 2

Self-Affirmation

Interventional

behavioral

Sponsor & Location

Elizabeth Scharnetzki

MaineHealth

Westbrook, United States of America

Timeline & Enrollment

N/A

Apr 01, 2024

Feb 28, 2027

150 participants

Primary Outcome

Social Identity Threat Concerns (SITC) Scale,Two-Factor Weight Bias Internalization Scale,Diabetes Stigma Assessment Scale,The Revised Diabetes Self-Management Questionnaire,Confidence in Diabetes Self-Care Scale,Blood glucose

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.

ICD-10 Classifications

Type 2 diabetes mellitus
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT06348238

Non-Device Trial