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

NCT07019649 | Enrolling By Invitation

• 1 other identifier: 2225114-1
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Differences between study arms in HbA1c change 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.

  6-months following enrollment

Secondary Outcomes (9)

• Healthcare contact

  6-months following enrollment

• Completion of recommended HbA1c monitoring

  6-months following enrollment

• T2D-related medication initiation

  6-months following enrollment

• T2D-related medication adherence

  6-months following enrollment

• Use of remote glucose monitoring to measure glucose levels

  6-months following enrollment

Study Arms (2)

AYUDA Program

EXPERIMENTAL

Participants enrolled in the AYUDA program will receive text messages twice a week containing education and resources related to diabetes care and self-management, in addition to their usual diabetes care.

Behavioral: AYUDA Program

Usual Care

NO INTERVENTION

No intervention will be employed. This arm will continue to receive their usual diabetes care.

Interventions

AYUDA Program BEHAVIORAL

Participants randomized to the intervention arm will be enrolled in the AYUDA program, where they will receive text messages twice a week over 12 weeks containing diabetes education and self-management resources, including links to resources available to all KPNC members.

AYUDA Program

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Type 1 Diabetes

Sponsors & Collaborators

• Kaiser Permanente: lead
• American Diabetes Association: collaborator

Study Sites (1)

Kaiser Permanente Northern California

Pleasanton, California, 94588, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)