NCT06770673

Brief Summary

The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
29mo left

Started Mar 2025

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Mar 2025Oct 2028

First Submitted

Initial submission to the registry

January 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 11, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

January 8, 2025

Last Update Submit

January 22, 2026

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Glycated hemoglobin (HbA1c)

    Glycated hemoglobin as measured by a point-of-care A1c test

    Baseline, 3 months, 6 months, and 12 months

Study Arms (2)

Together Overcoming Diabetes Intervention

EXPERIMENTAL

Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families

Behavioral: TOD Great Plains

Waitlist Standard of Care

PLACEBO COMPARATOR

Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.

Behavioral: Waitlist Standard of Care

Interventions

TOD Great PlainsBEHAVIORAL

The adapted TOD intervention is rooted in the original TOD structure, delivery system, and home-visiting teaching schedule. Local enhancements include intervention topics and activities to address local adult caregivers' diabetes management and to promote families' modifiable risk and protective factors targeted by this proposal and informed by the Wicozani wellness concept and measurement. The TOD intervention includes targeted content taught approximately bi-weekly by family health coaches over a 16-week period.

Together Overcoming Diabetes Intervention
Waitlist Standard of CareBEHAVIORAL

Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.

Waitlist Standard of Care

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Self-identifies as American Indian or Alaska Native
  • Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center
  • Verification from a health provider to confirm Type 2 Diabetes diagnosis by laboratory test.
  • Caregiver to a 10- to 25-year-old in their home at the time of screening.
  • Willing to complete all implementation and follow-up assessments.
  • Willing to be randomized for the intervention.

You may not qualify if:

  • Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
  • Willing to serve as 'support person' for the adult participant.
  • Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation
  • Between 10 years and 25 years old
  • Self-identifies as American Indian or Alaska Native.
  • Willing to serve as 'support person' for the adult participant.
  • Willing to complete all implementation and follow-up assessments.
  • Willing to be randomized for the intervention.
  • Cognitively or visually impaired
  • Youth in foster care (due to potential mobility of foster youth).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Indigenous Health - Great Plains Hub

Rapid City, South Dakota, 57701, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Donald Warne, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Claussen, PhD

CONTACT

605-200-0043cclauss1@jh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Independent Evaluators are masked to the study participants' randomized group status/
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Waitlist randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 13, 2025

Study Start

March 11, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)