RecruitingNot ApplicableNCT06988306

Lifestyle Interventions to Prevent Diabetes in U.S. Home Visiting Programs

Randomized Controlled Trial of Lifestyle Interventions for the Prevention of Diabetes in US Home Visiting Programs

Sponsor

California Polytechnic State University-San Luis Obispo

Enrollment

978 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Gestational Diabetes Mellitus (GDM)

Summary

The study is examining the health effects of gestational diabetes mellitus (GDM) intervention and medically tailored meals within home visiting. A large study is proposed that will include nearly a thousand pregnant or recently pregnant adults with recent GDM and who are from different regions and backgrounds. Two treatment approaches are compared, and both are in home visiting. One treatment group is receiving enhanced lifestyle support for GDM along with meals, and the other is receiving just the enhanced lifestyle support. The study will examine whether these interventions help reduce diabetes and pre-diabetes through 12 months postpartum, as well as other health factors like weight and blood pressure.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

Currently in home visiting
Pregnant or \< 3 months (13 weeks) postpartum
Gestational Diabetes Mellitus diagnosis in most recent pregnancy (based on self-report)
Aged 18 years or older
English- or Spanish-speaking.
Not currently being given medically tailored meals
Willing to receive randomization to either group

Exclusion Criteria1

• Pre-existing diabetes (based on self-report)

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Interventions

BEHAVIORALGDM Enhanced

The GDM Enhanced intervention is comprised of HV-delivered, evidence-based modules (10-20 minutes) with facilitator guides. The content prioritizes management and prevention of diabetes through healthy eating, physical activity, and stigma-informed weight management strategies.

BEHAVIORALMeals

The Meal intervention includes medically tailored meals being provided to participants starting after randomization and tailored to their individual dietary preferences and cultural considerations.