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Enrolling by Invitation

NCT Number: NCT07019649

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California

Pleasanton, California, 94588, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Differences between study arms in HbA1c change 6-months following enrollment

    Time frame: 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 outcomes

  1. Healthcare contact

    Time frame: 6-months following enrollment

    Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators.

  2. Completion of recommended HbA1c monitoring

    Time frame: 6-months following enrollment

    Completing HbA1c labs

  3. T2D-related medication initiation

    Time frame: 6-months following enrollment

    Initiation of T2D-related medication

  4. T2D-related medication adherence

    Time frame: 6-months following enrollment

    Adherence to T2D-related medication

  5. Use of remote glucose monitoring to measure glucose levels

    Time frame: 6-months following enrollment

    Use of a remote glucose monitoring to measure glucose levels

  6. Participant-reported measures: Diabetes distress

    Time frame: Study enrollment and 6-months following enrollment

    Assessed at study enrollment and 6-months following enrollment

  7. Participant-reported measures: Motivation and locus of control

    Time frame: Study enrollment and 6-months following enrollment

    Assessed at study enrollment and 6-months following enrollment

  8. Participant-reported measures: Care Experience

    Time frame: Study enrollment and 6-months following enrollment

    Assessed at study enrollment and 6-months following enrollment

  9. Participant-reported measures: Children's Behaviors

    Time frame: Study enrollment and 6-months following enrollment

    Assessed at study enrollment and 6-months following enrollment

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Tailoring Initial Type 2 Diabetes Care to Meet the Needs of Younger Latinx Adults: A Randomized Pilot Study

Acronym: AYUDA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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