ClinicalTrials.gg
Not yet recruitingNCT07822555DEEPUpdated Nov 5, 2026

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

An interventional study of Diabetes & Equine Empowerment Program (DEEP) in Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes and Diabetes (DM), sponsored by Nemours Children's Clinic. Not yet recruiting. Open to participants aged 8 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Supportive care

Updated Nov 5, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
8 Years to 20 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diabetes (Insulin-requiring, Type 1 or Type 2)
  • Pediatric Diabetes
  • Diabetes (DM)

Keywords

  • Pediatric Diabetes
  • Young Adults with Diabetes
  • Self-Management Education for Diabetes
  • Equine -Assisted Therapy
  • Eqauine-Assisted Learning
  • Diabetes Education
  • Patient Engagement
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Nemours Children's Clinic is the lead sponsor of 130 studies on the registry; 26 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 8 to 20 years
  • Diagnosis of type 1 or type 2 diabetes
  • Most recent 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 /assent, as applicable
  • Caregiver willing to participate in study activities and assessments

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Diabetes & Equine Empowerment Program (DEEP)

Interventions

  • BehavioralDiabetes & Equine Empowerment Program (DEEP)

    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.

    Also known as: DEEP, Miniature Equine-Assisted Diabetes Education

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. Program Completion Rate

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

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

Secondary outcomes

  1. 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

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

  2. 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.

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

  3. 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

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

  4. 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.

    Time frame: Program completion through six months after program completion

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Oct 2027, 8 months later.

Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 8 months is below that.

Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Jan 2027, on Nov 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Sep 16, 2026
StartEst.
Jan 12, 2027was Oct 2026
Primary completionEst.
Oct 1, 2027
CompletionEst.
Oct 1, 2028
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 1, 2026→Jan 12, 2027
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Start date Oct 1, 2026→Jan 12, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07822555
Responsible party
Jennifer Pfieffer (Principal Investigator, Nemours Children's Health System) — Principal investigator
First posted
Sep 16, 2026
Start date
Jan 12, 2027 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Jennifer E Pfieffer, APRN, PCNS-BC, ESMHL
Contact
Jennifer.Pfieffer@nemours.org
904-697-3600
Susana Patton, PhD, ABPP, CDCES
study director · Nemours Children's Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion