Recruiting

GDM & Meals

Sponsor:

California Polytechnic State University-San Luis Obispo

Code:

NCT06988306

Conditions

Diabetes Mellitus

Gestational Diabetes Mellitus (GDM)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GDM Enhanced

Meals

Study Details

Brief 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.

Conditions

Diabetes Mellitus

Gestational Diabetes Mellitus (GDM)

Study ID

NCT06988306

Start date

Jan 15, 2026

Status verified date

Mar, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

978 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Usual Home Visiting plus GDM Enhanced

This group receives usual home visitation plus GDM Enhanced intervention.

experimental: Usual HV + GDM Enhanced + Meals

This group will receive usual home visitation plus GDM Enhanced plus medically tailored meals.

Interventions

GDM 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.

Meals

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

Primary outcome measure

  • Diabetes/Pre-Diabetes [ Time Frame: From enrollment to 12 months postpartum ]

Central Contacts and Locations

Central contacts

Brooke Latzke-Davis, BS

805-756-5694blatzked@calpoly.edu

Locations

California Polytechnic State University

Recruiting

San Luis Obispo, California, United States, 93401

Contacts

Suzanne Phelan, PhD

8057562087sphelan@calpoly.edu

More Information

Sponsor

California Polytechnic State University-San Luis Obispo

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • medically tailored meals
  • gestational diabetes
  • food is medicine
  • home visiting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by California Polytechnic State University-San Luis Obispo on 2026-03-05.