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

Kaiser Permanente

Status: Invitation-only

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: AYUDA Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07019649

2225114-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

AYUDA Program

Experimental group

Description:

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.

Treatment:

Behavioral: AYUDA Program

Usual Care

No Intervention group

Description:

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