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NCT06348238 · ClinicalTrials.gov registry record · NA

Strategies to Improve Well-Being and Diabetes Management

A NA study of Diabetes Mellitus, Type 2, sponsored by Elizabeth Scharnetzki.

Recruiting
Registry status
NA
Development phase
150
Enrollment target
1
Study location

NCT06348238 is a NA study of Diabetes Mellitus, Type 2 that is actively recruiting participants, run by Elizabeth Scharnetzki. The registered enrollment target is 150 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06348238, a NA study of Diabetes Mellitus, Type 2, is actively recruiting participants, sponsored by Elizabeth Scharnetzki.

RECRUITING
Registry status
NA
Development phase
150 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • BEHAVIORAL Self-Affirmation

Study Locations (1)

Maine

  • MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research - Westbrook

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-07-24
Est. Completion 2027-02-28
Phase NA

Sponsor

Elizabeth Scharnetzki

1 total trials

What the Registry Record Tells You About NCT06348238

The ClinicalTrials.gov registry entry for NCT06348238 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower). The listed sponsor is Elizabeth Scharnetzki, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which Self-Affirmation is the first listed.

NCT06348238 reports 1 study location spanning 1 distinct geographic area - top geographies include Maine.

Frequently Asked Questions

What is clinical trial NCT06348238 about?

NCT06348238 is a clinical study titled "Strategies to Improve Well-Being and Diabetes Management". 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-wort...

What is the current status of trial NCT06348238?

This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2024-07-24. Estimated completion is 2027-02-28.

What conditions does trial NCT06348238 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.

What interventions are being tested in trial NCT06348238?

The interventions under investigation include: Self-Affirmation (BEHAVIORAL).

Who is sponsoring clinical trial NCT06348238?

This trial is sponsored by Elizabeth Scharnetzki, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06348238 being conducted?

This trial has 1 study location across Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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