Diabetes (Insulin-requiring, Type 1 or Type 2)DEEPNCT07822555
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
A study testing Diabetes & Equine Empowerment Program (DEEP) in people with Diabetes (Insulin-requiring, Type 1 or Type 2) and Pediatric Diabetes, run by Nemours Children's Clinic.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes, Diabetes (DM)
- What is being tested?
- Diabetes & Equine Empowerment Program (DEEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2027to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- Able to attend all four study sessions
- Able to provide informed consent/assent, as applicable
- Caregiver willing to participate in study activities and assessments
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tiny Hooves, Big Impact - A Feasibility Study of Miniature Equine-Assisted Diabetes Education for Children With Diabetes
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.
Read the detailed description
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.
- Being tested
- Diabetes & Equine Empowerment Program (DEEP)
- Keywords
- Pediatric Diabetes, Young Adults with Diabetes, Self-Management Education for Diabetes, Equine -Assisted Therapy, Eqauine-Assisted Learning, Diabetes Education, Patient Engagement
- Medical subject headings
- Diabetes Mellitus, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes & Equine Empowerment Program (DEEP)Behavioural
Also called DEEP, Miniature Equine-Assisted Diabetes Education
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes & Equine Empowerment Program (DEEP) | Experimental | Participants in this single-arm intervention will receive the Diabetes \& Equine Empowerment Program (DEEP), a miniature equine-assisted diabetes education program. Participants and their caregivers will attend four structured sessions led by a diabetes specialist and a certified equine specialist. Sessions combine experiential learning activities with diabetes education focused on self-management, coping skills, problem-solving, self-advocacy, and transition readiness. The study will evaluate feasibility, acceptability, participant satisfaction, and exploratory psychosocial and behavioral outcomes. Receives: Behavioral: Diabetes & Equine Empowerment Program (DEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment Rate
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.
Measured: From study initiation through completion of enrollment (approximately 9 months)
Participant Retention Rate
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.
Measured: From enrollment through completion of study participation (approximately 9 months)
Program Attendance Rate
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.
Measured: From enrollment through completion of study participation (approximately 9 months)
Program Completion Rate
Completion feasibility will be assessed by the proportion of enrolled participants who complete all four miniature equine-assisted diabetes education sessions.
Measured: From enrollment through completion of study participation (approximately 9 months)
Secondary outcomes (4)
Change in Diabetes Distress Assessed by the Problem Areas in Diabetes Questionnaires (PAID-C/PAID-T)
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
Measured: Baseline to immediately after completion of the four-session DEEP program
Change in Diabetes Self-Management Behaviors Assessed by the Self-Care Inventory-Updated (SCI-U)
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.
Measured: Baseline to immediately after completion of the four-session DEEP program
Routine Diabetes Appointment Attendance Assessed by Electronic Health Record Review
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
Measured: Six months before participation through six months after program completion
Diabetes Technology Initiation Assessed by Electronic Health Record Review
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.
Measured: Program completion through six months after program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start12 Jan 2027 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (Insulin-requiring, Type 1 or Type 2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment. All enrolled participants receive the DEEP intervention, a structured miniature equine-assisted diabetes education program. The study is designed as a single-arm feasibility and acceptability trial with no randomization or comparison group. Participants and caregivers complete four educational sessions that integrate experiential learning with diabetes self-management education. Outcomes are collected longitudinally to evaluate feasibility, acceptability, participant satisfaction, and exploratory psychosocial and behavioral measures.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Pfieffer, Nemours Children's Health System
- Investigators
- Susana Patton, PhD, ABPP, CDCES, Study director, Nemours Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822555
- Sponsor's protocol ID
- MOD00002923
- Acronym
- DEEP
- Status last verified
- Nov 2026
- First submitted
- 18 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing plans have not yet been determined. Because this is an early-stage feasibility study with a small sample size, data sharing considerations will be evaluated following completion of the study and analysis of the results. Any future sharing of de-identified data will be considered in accordance with applicable regulations, institutional policies, participant privacy protections, and informed consent provisions.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tiny Hooves, Big Impact - A Feasibility Study of Miniature Equine-Assisted Diabetes Education for Children With Diabetes
- ClinicalTrials.gov ID
- NCT07822555
- Acronym / sponsor ID
- DEEP / MOD00002923
- Keywords
- Pediatric Diabetes, Young Adults with Diabetes, Self-Management Education for Diabetes, Equine -Assisted Therapy, Eqauine-Assisted Learning, Diabetes Education, Patient Engagement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 12 Jan 2027 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment. All enrolled participants receive the DEEP intervention, a structured miniature equine-assisted diabetes education program. The study is designed as a single-arm feasibility and acceptability trial with no randomization or comparison group. Participants and caregivers complete four educational sessions that integrate experiential learning with diabetes self-management education. Outcomes are collected longitudinally to evaluate feasibility, acceptability, participant satisfaction, and exploratory psychosocial and behavioral measures.
| Arm | Type | Receives |
|---|---|---|
| Diabetes & Equine Empowerment Program (DEEP) | Experimental | Behavioral: Diabetes & Equine Empowerment Program (DEEP)Participants in this single-arm intervention will receive the Diabetes \& Equine Empowerment Program (DEEP), a miniature equine-assisted diabetes education program. Participants and their caregivers will attend four structured sessions led by a diabetes specialist and a certified equine specialist. Sessions combine experiential learning activities with diabetes education focused on self-management, coping skills, problem-solving, self-advocacy, and transition readiness. The study will evaluate feasibility, acceptability, participant satisfaction, and exploratory psychosocial and behavioral outcomes. |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes & Equine Empowerment Program (DEEP)Also: DEEP, Miniature Equine-Assisted Diabetes EducationThe 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. | Behavioural | Diabetes & Equine Empowerment Program (DEEP) |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
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 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
Routine Diabetes Appointment Attendance Assessed by Electronic Health Record Review
Time frame: Six months before participation through six months after program completion
Diabetes Technology Initiation Assessed by Electronic Health Record Review
Time frame: Program completion through six months after program completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing plans have not yet been determined. Because this is an early-stage feasibility study with a small sample size, data sharing considerations will be evaluated following completion of the study and analysis of the results. Any future sharing of de-identified data will be considered in accordance with applicable regulations, institutional policies, participant privacy protections, and informed consent provisions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susana Patton, PhD, ABPP, CDCES study director
Nemours Children's Health
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes & Equine Empowerment Program (DEEP) in people with Diabetes (Insulin-requiring, Type 1 or Type 2) and Pediatric Diabetes, run by Nemours Children's Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer E Pfieffer, APRN, PCNS-BC, ESMHL (904-697-3600, Jennifer.Pfieffer@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment Rate (time frame: From study initiation through completion of enrollment (approximately 9 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.