Participants Needed Online Group Diabetes Treatment Study

M
Mary de Groot, PhD

Primary Investigator

Recruiting
21-100 years
Female
Phase N/A
10 participants needed
1 Location

Brief description of study

What is the purpose of this study?

This research is being done so that we can learn more about helping adults with type 2 diabetes who want to improve their diabetes self-management behaviors. Specifically, we are testing an online group treatment called Finding Your Balance with Diabetes.

Detailed description of study

What will happen during the study?

As part of the study, all participants will attend 8 weekly online group sessions (90 min each). The group will be led by a health psychologist and a licensed clinical social worker.  Sessions will involved discussing a variety of topics including:

  • emotion management through identification of autonomic nervous system state cues and relaxation practice.
  • social support and communication strategies to reduce miscarried helping, and
  • behavioral strategies to support diabetes self-management.

Before starting the first session, participants will complete an assessment consisting of a fingerstick A1c test, height, weight, several questionnaires, and heart rate testing. Immediately after the last session, participants will complete another assessment, similar to the first assessment. We will then ask participants to return about two months later for a final assessment, similar to the first two. Participants will also be asked to wear a heart rate monitor at various times during the group treatment sessions.

Incentive/compensation

  • Participants may earn up to $150 in gift cards by email for completion of all parts of the study.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 2 Diabetes ,T2D
  • Age: Between 21 Years - 100 Years
  • Gender: Female

Inclusion Criteria

  • proficiency in English language (ability to speak, read, and write fluently in English)
  • Self-identify as female
  • Age ≥ 21 years
  • Type 2 diabetes diagnosis ≥ 1 year
  • A1c ≥ 7.0% in the past year per EMR or patient report
  • DDS-17 score ≥ 2.0 at screening
  • Active email address
  • Resides in central Indiana (Marion County or the nine counties immediately surrounding Marion County)
  • Ownership of a smartphone compatible with the heart rate monitor app
    • iPhone 4S or higher (made in 2011 or more recently)
    • Android phone Galaxy S3 or more recent (made since 2012 or more recently)
  • Access to a freezer at home

Exclusion Criteria

  • Limited English language proficiency
  • Any medical condition, mental health or cognition issue, that, would in the opinion of the investigator, makes the participant ineligible to participate. Diagnosis of a major acute medical condition (e.g., myocardial infarction, stroke, cardiac rehabilitation, stage 3 or stage 4 cancer diagnoses) within the last three months
  • Major hospitalization in the past 6 months requiring an overnight stay
  • Current use of a pacemaker
  • Initiation of new medical treatment regimens (e.g., chemotherapy) for acute medical diagnoses that would require the patient’s primary attention

Updated on 20 Nov 2024. Study ID: ENDO-IIR-EPVT, 24598

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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