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

NCT06988306 | Recruiting DMC

• 2 other identifiers: 2025-056MMM-2024C1-37760
• Study Type: interventional
• Target: 978
• Locations: 1 country
• Sites: 3

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diabetes/Pre-Diabetes

  The Primary Outcome Measure in this study is a categorical outcome of glucose tolerance (i.e., healthy glucose tolerance vs. type 2 diabetes/pre-diabetes) at 12 months postpartum. The test will be conducted at CLIA-certified lab. A 2-hour oral glucose tolerance test (OGTT) will characterize people into one of two categories: 1) healthy glucose tolerance; or 2) type 2 diabetes (2-hour post 75g load glucose level of 200 mg/dL or greater) or pre-diabetes (a 2-hour post 75g load glucose level of 140 to 199 mg/d).

  From enrollment to 12 months postpartum

Secondary Outcomes (14)

• HbA1c concentration

  From enrollment to 3, 6, and 12 months postpartum

• Systolic blood pressure

  From enrollment to 3, 6, and 12 months postpartum

• Diastolic blood pressure

  From enrollment to 3, 6, and 12 months postpartum

• Body weight

  From enrollment to 3, 6, and 12 months postpartum

• Child zBMI

  From 3 months to 6 and 12 months

Other Outcomes (3)

• Feasibility of Intervention Measure

  12 months postpartum

• Acceptability of Intervention Measure

  12 months postpartum

• Intervention Appropriateness Measure

  12 months postpartum

Study Arms (2)

Usual Home Visiting plus GDM Enhanced

ACTIVE COMPARATOR

This group receives usual home visitation plus GDM Enhanced intervention.

Behavioral: GDM Enhanced

Usual HV + GDM Enhanced + Meals

EXPERIMENTAL

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

Behavioral: GDM Enhanced; Behavioral: Meals

Interventions

GDM Enhanced BEHAVIORAL

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.

Usual HV + GDM Enhanced + Meals; Usual Home Visiting plus GDM Enhanced

Meals BEHAVIORAL

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

Usual HV + GDM Enhanced + Meals

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lifespan/ The Miriam Hospital: collaborator
• Northwestern University: collaborator
• Bradley Hospital: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• California Polytechnic State University-San Luis Obispo: lead

Study Sites (3)

California Polytechnic State University

San Luis Obispo, California, 93401, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Miriam Hospital

Providence, Rhode Island, 02906, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes, Gestational

Interventions

Meals

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Suzanne Phelan, PhD

  California Polytechnic State University-San Luis Obispo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Latzke-Davis, BS

CONTACT

805-756-5694; blatzked@calpoly.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: May 23, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: April, 2031
• Access Criteria: Data will be made available to qualified researchers upon reasonable request and completion of a data use agreement that protects participant confidentiality and outlines permitted uses of the data.

Locations

US (3)