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Enrolling by invitation NCT07019649

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

No phase Interventional Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AYUDA Program.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 44 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Behavioral AYUDA Program
    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 outcome measures

  • Differences between study arms in HbA1c change 6-months following enrollment [Time frame: 6-months following enrollment]
Secondary outcome measures (9)
  • Healthcare contact [Time frame: 6-months following enrollment]
  • Completion of recommended HbA1c monitoring [Time frame: 6-months following enrollment]
  • T2D-related medication initiation [Time frame: 6-months following enrollment]
  • T2D-related medication adherence [Time frame: 6-months following enrollment]
  • Use of remote glucose monitoring to measure glucose levels [Time frame: 6-months following enrollment]
  • Participant-reported measures: Diabetes distress [Time frame: Study enrollment and 6-months following enrollment]
  • Participant-reported measures: Motivation and locus of control [Time frame: Study enrollment and 6-months following enrollment]
  • Participant-reported measures: Care Experience [Time frame: Study enrollment and 6-months following enrollment]
  • Participant-reported measures: Children's Behaviors [Time frame: Study enrollment and 6-months following enrollment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Kaiser Permanente Northern California — Pleasanton

Identifiers

NCT: NCT07019649 · 2225114-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗