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NCT Number: NCT07822555

A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).

The Diabetes & Equine Empowerment Program (DEEP) is a research study evaluating a novel diabetes education program that combines hands-on interactions with miniature horses and evidence-based diabetes self-management education for youth ages 8-20 years with diabetes. Participants and their caregivers attend four structured educational sessions led by a diabetes specialist and a certified equine specialist. Topics include diabetes self-management, coping skills, problem-solving, self-advocacy, and transition readiness. Researchers will evaluate whether the program is feasible to deliver, acceptable to participants and families, and helpful in supporting engagement in diabetes care. Participants will be followed for up to six months after the program, and study outcomes include satisfaction, diabetes-related distress, self-care behaviors, clinic attendance, and diabetes technology use.

In simple terms, this study is exploring whether learning about diabetes through guided activities with miniature horses can help children, adolescents, and young adults feel more confident in managing their diabetes, improve self-care skills, and become more engaged in their health care. The goal is to determine whether this innovative educational approach is practical to offer and valued by patients, families, and health care providers.

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Key information

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2) Behavior Diabetes (DM) Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Participation Pediatric Diabetes Treatment Adherence and Compliance

Age range

8 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Youth with diabetes often face challenges related to self-management, problem-solving, coping with the daily demands of diabetes, and developing the skills needed for increasing independence. Innovative approaches that promote engagement and active participation may help address these challenges while supporting diabetes education and self-confidence.

The Diabetes & Equine Empowerment Program (DEEP) was developed to integrate experiential learning with diabetes education through structured interactions with miniature horses. The program is designed to create a supportive, interactive environment in which participants can practice communication, goal setting, self-advocacy, and problem-solving while reinforcing key diabetes self-management concepts. Educational content is tailored to developmental level and incorporates activities intended to enhance engagement, self-efficacy, and readiness for independent diabetes management.

This single-arm feasibility study will evaluate the implementation of the DEEP program among youth with diabetes and their caregivers. Participants will complete a series of structured sessions facilitated by a diabetes specialist and a certified equine specialist. The study will examine the practicality of recruitment strategies, participant retention, attendance, and completion of study activities. Acceptability of the intervention will be assessed through participant and caregiver feedback regarding satisfaction, perceived value, and willingness to recommend the program to others.

In addition to feasibility and acceptability outcomes, exploratory measures will assess potential changes in diabetes-related psychosocial and behavioral outcomes, including diabetes distress, self-management behaviors, healthcare engagement, and diabetes technology utilization. Data collected through participant-reported measures and medical record review will be used to inform future research and the potential development of larger controlled studies evaluating equine-assisted diabetes education interventions. Participants will be followed for up to six months after program completion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 8 to 20 years
  • Diagnosis of type 1 or type 2 diabetes
  • Most recent HbA1c greater than 9.0% OR no diabetes clinic follow-up for more than 6 months
  • English-speaking participant and caregiver
  • Receiving diabetes care at the participating study site
  • Willing and able to participate in the DEEP intervention
  • Able to attend all four study sessions
  • Able to provide informed consent/assent, as applicable
  • Caregiver willing to participate in study activities and assessments

Exclusion criteria

  • Non-English-speaking participant or caregiver
  • Medical, physical, cognitive, or behavioral condition that would prevent safe participation in study activities
  • Significant fear of horses that would limit participation
  • Allergy to horses that would limit participation
  • Previous participation in the DEEP intervention
  • Inability or unwillingness to complete study procedures or follow-up assessments
  • Any condition that, in the opinion of the investigators, would make participation unsafe or interfere with study completion

Treatment and study plan

Diabetes & Equine Empowerment Program (DEEP)

Behavioral

The Diabetes & Equine Empowerment Program (DEEP) is a behavioral and educational intervention that combines evidence-based diabetes self-management education with structured, hands-on interactions involving miniature horses. Youth with diabetes and their caregivers participate in four facilitated sessions led by a diabetes specialist and a certified equine specialist. Session activities are designed to reinforce diabetes self-management skills, coping strategies, problem-solving, communication, self-advocacy, and transition readiness through experiential learning. The intervention aims to improve participant engagement, confidence in diabetes management, and readiness for increasing independence while providing a supportive and interactive learning environment. The program is being evaluated for feasibility, acceptability, participant satisfaction, and potential effects on psychosocial and behavioral outcomes.

Other names: DEEP, Miniature Equine-Assisted Diabetes Education

Primary outcomes

  1. Participant Recruitment Rate

    Time frame: From study initiation through completion of enrollment (approximately 9 months)

    Recruitment feasibility will be assessed by the proportion of eligible participants who enroll in the four-session miniature equine-assisted diabetes education program, as documented in study enrollment records.

  2. Participant Retention Rate

    Time frame: From enrollment through completion of study participation (approximately 9 months)

    Retention feasibility will be assessed by the proportion of enrolled participants who remain in the study and complete scheduled study assessments, as documented in study records.

  3. Program Attendance Rate

    Time frame: From enrollment through completion of study participation (approximately 9 months)

    Attendance feasibility will be assessed by the proportion of scheduled miniature equine-assisted diabetes education sessions attended by participants, as documented in program attendance logs.

  4. Program Completion Rate

    Time frame: From enrollment through completion of study participation (approximately 9 months)

    Completion feasibility will be assessed by the proportion of enrolled participants who complete all four miniature equine-assisted diabetes education sessions.

Secondary outcomes

  1. Change in Diabetes Distress Assessed by the Problem Areas in Diabetes Questionnaires (PAID-C/PAID-T)

    Time frame: Baseline to immediately after completion of the four-session DEEP program

    Change in diabetes-related emotional distress among youth participants as measured by the Problem Areas in Diabetes questionnaires, including the PAID-C for participants ages 8-12 years and the PAID-T for participants ages 13-17 years. Higher scores indicate greater diabetes-related distress

  2. Change in Diabetes Self-Management Behaviors Assessed by the Self-Care Inventory-Updated (SCI-U)

    Time frame: Baseline to immediately after completion of the four-session DEEP program

    Change in diabetes self-management behaviors as measured by the Self-Care Inventory-Updated (SCI-U), a validated self-report questionnaire that assesses adherence to diabetes self-care activities, including blood glucose monitoring, medication administration, and diabetes-related self-management tasks. Higher scores indicate better adherence to the diabetes care plan.

  3. Routine Diabetes Appointment Attendance Assessed by Electronic Health Record Review

    Time frame: Six months before participation through six months after program completion

    Change in routine diabetes clinic appointment attendance as assessed through electronic health record review. Attendance will be evaluated by comparing the proportion of scheduled diabetes clinic visits attended before participation and following completion of the DEEP program

  4. Diabetes Technology Initiation Assessed by Electronic Health Record Review

    Time frame: Program completion through six months after program completion

    The number of participants who initiate diabetes technology, including continuous glucose monitoring and/or insulin pump therapy, within six months following program completion, as documented through electronic health record review.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer E Pfieffer, APRN, PCNS-BC, ESMHL

CONTACT

[email protected]

904-697-3600

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

Tiny Hooves, Big Impact - A Feasibility Study of Miniature Equine-Assisted Diabetes Education for Children With Diabetes

Acronym: DEEP

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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