Clinical trial NCT07019649: Randomized Pilot Trial of AYUDA Program for Younger Latinx Adults With Type 2 Diabetes
Official title: Tailoring Initial Type 2 Diabetes Care to Meet the Needs of Younger Latinx Adults: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2025-06-13
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences between study arms in HbA1c change 6-months following enrollment
timeFrame: 6-months following enrollment
Secondary outcomes:
measure: Healthcare contact
timeFrame: 6-months following enrollment
measure: Completion of recommended HbA1c monitoring
timeFrame: 6-months following enrollment
measure: T2D-related medication initiation
timeFrame: 6-months following enrollment
measure: T2D-related medication adherence
timeFrame: 6-months following enrollment
measure: Use of remote glucose monitoring to measure glucose levels
timeFrame: 6-months following enrollment
measure: Participant-reported measures: Diabetes distress
timeFrame: Study enrollment and 6-months following enrollment
measure: Participant-reported measures: Motivation and locus of control
timeFrame: Study enrollment and 6-months following enrollment
measure: Participant-reported measures: Care Experience
timeFrame: Study enrollment and 6-months following enrollment
measure: Participant-reported measures: Children's Behaviors
timeFrame: Study enrollment and 6-months following enrollment
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
References: