Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06348238

Strategies to Improve Well-Being and Diabetes Management

Led by Elizabeth Scharnetzki · Updated on 2025-09-03

150

Participants Needed

1

Research Sites

135 weeks

Total Duration

On this page

Sponsors

E

Elizabeth Scharnetzki

Lead Sponsor

M

MaineHealth

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Strategies to Improve Well-Being and Diabetes Management

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be at least 18 years old
  • Have a diagnosis of type 2 diabetes (T2D)
  • Currently use a continuous glucose monitor (Dexcom, FreeStyle Libre) as part of their diabetes management
  • Be a patient of MaineHealth Endocrinology and Diabetes
Not Eligible

You will not qualify if you...

  • Individuals under 18 years of age

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Westbrook, Maine, United States, 04092

Actively Recruiting

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Research Team

E

Elizabeth Scharnetzki

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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