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NCT06348238Not yet recruiting

Strategies to Improve Well-Being and Diabetes Management

Elizabeth ScharnetzkiClinicalTrials.govbehavioral
Study focus
Drug/Device/Intervention
Self-Affirmation
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Elizabeth Scharnetzki
Funder
MaineHealth
Location
Westbrook, United States of America
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2024
End date
Feb 28, 2027
Enrollment
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 mellitusType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06348238
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.