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NCT06348238Active, not recruiting

Strategies to Improve Well-Being and Diabetes Management

Source: ClinicalTrials.gov · Last updated 1 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
4 Mar 2024
Start date
24 Jul 2024
Primary completion date
10 Nov 2026
Lead sponsor
Elizabeth Scharnetzki
NCT number
NCT06348238

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 24 Jul 2024 to the primary completion date, 10 Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Individuals under 18 years of age

Who the study is looking for

  • 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.
  • Participants must be patients of MaineHealth Endocrinology and Diabetes, 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 (Dexcom, FreeStyle Libre).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research
Coordinator of this site? Confirm its status
WestbrookUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.