Randomized Pilot Trial of AYUDA Program for Younger Latinx Adults With Type 2 Diabetes

Not Applicable

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT07019649
• Lead Sponsor: Kaiser Permanente

Brief Summary

The study will evaluate the feasibility, acceptability, and effectiveness of AYUDA (Assisting Younger Adults with Diabetes), a 12-week culturally text message program for Latinx adults newly diagnosed with type 2 diabetes who are caregivers to a child under 18 years old within Kaiser Permanente Northern California.

Detailed Description

After designing the AYUDA program with input from the people it is meant to help, we are conducting a randomized pilot study. This study will test the program with younger Latinx adults who have recently been diagnosed with type 2 diabetes and who are also caregivers for dependent children.

AYUDA is a health system specifically designed for this group, focusing on their life stage as young adults and their cultural background. The study will evaluate how well AYUDA helps participants reach important early blood sugar control goals, which can lead to better health over time and reduce complications.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-06-18
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• KPNC member, age >18 and age <45 with
• New clinical diagnosis of T2D within the prior 6 months
• Caregiver to at least one child <18 years of age at time of diabetes diagnosis
• Identifies at Latino/a/x
• Can receive text messages
• Proficient (written and spoken) in English or Spanish

Exclusion Criteria

• Pregnant women
• Type 1 Diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Differences between study arms in HbA1c change 6-months following enrollment	6-months following enrollment	Change in HbA1c will be assessed using HbA1c values obtained through routine care, with the most recent HbA1c preceding study enrollment and the HbA1c value closest to 6-months following enrollment used to assess HbA1c change.

Secondary Outcome Measures

Name	Time	Method
Participant-reported measures: Children's Behaviors	Study enrollment and 6-months following enrollment	Assessed at study enrollment and 6-months following enrollment
T2D-related medication initiation	6-months following enrollment	Initiation of T2D-related medication
T2D-related medication adherence	6-months following enrollment	Adherence to T2D-related medication
Healthcare contact	6-months following enrollment	Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators.
Completion of recommended HbA1c monitoring	6-months following enrollment	Completing HbA1c labs
Use of remote glucose monitoring to measure glucose levels	6-months following enrollment	Use of a remote glucose monitoring to measure glucose levels
Participant-reported measures: Diabetes distress	Study enrollment and 6-months following enrollment	Assessed at study enrollment and 6-months following enrollment
Participant-reported measures: Motivation and locus of control	Study enrollment and 6-months following enrollment	Assessed at study enrollment and 6-months following enrollment
Participant-reported measures: Care Experience	Study enrollment and 6-months following enrollment	Assessed at study enrollment and 6-months following enrollment

Trial Locations

Locations (1)

Kaiser Permanente Northern California; 🇺🇸 Pleasanton, California, United States