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

NCT ID: NCT06988306

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 978 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2030-04-30

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.

Detailed Description

Gestational diabetes mellitus (GDM) is rapidly rising in prevalence and has been linked with several short and long-term adverse maternal health outcomes, including type 2 diabetes (T2DM) and cardiovascular disease. The postpartum year is a time of heightened risk, and 32-46% of people with GDM develop type 2 diabetes (T2DM) or Pre-Diabetes (PreDM) during the postpartum year. To prevent maternal diabetes, US guidelines recommend behavioral counseling to promote healthy eating, activity, and weight, but dissemination channels have been lacking. Evidence-based home visiting programs, with their well-established infrastructure in every state and focus on maternal and child health, are a promising platform through which the recommended behavioral interventions could reach people with GDM and reduce health disparities. Effective GDM intervention within home visiting needs to be potent, build on existing content, and remain brief, so as not to displace other evidence-based content. Integrating referral to medically tailored meals (MtMs) is a Food is Medicine strategy that may prevent and mitigate maternal diabetes in home visiting. Access to MtMs has been expanding rapidly in the US, with 10 states currently having and 5 states pending Medicaid Service waivers that offer coverage for MtMs. Systematic reviews have found that providing MtMs allows patients to experience significantly better glucose and weight management, improved food insecurity and dietary quality, and greater treatment satisfaction. MtMs also benefit health systems, insurers, and governments through reduced costs and fewer hospitalizations and emergency department visits. However, national calls and systematic reviews have identified a major evidence gap and the need for adequately powered effectiveness trials to determine whether MtMs are effective in treating and preventing maternal diabetes. For MtMs to continue as a treatment approach for GDM, compelling evidence is needed that they work and for whom and in what context. The primary aim of this study is to evaluate the 12-month incidence T2DM/PreDM in people with GDM who receive GDM Enhanced + Meals vs. GDM Enhanced Only within home visiting. A robust implementation process evaluation will inform ensure successful sustainment and reach for diverse pregnant and postpartum people with GDM. A Hybrid Type 1 effectiveness-implementation trial is proposed. The study will recruit 978 perinatal, English or Spanish-speaking adults nationwide from three clinical centers serving the West, Midwest/South, and East regions. Home visiting clients (35% Black; 40% Hispanic) with recent GDM diagnosis and will be randomized within site and home visiting agency to one of two treatment arms: GDM enhanced lifestyle intervention plus MtMs (GDM Enhanced + Meals) or GDM Enhanced Only. The primary study aim is to evaluate the 12-month incidence of T2DM/PreDM. Secondary aims will examine treatment group differences in health factors (weight, blood pressure) and client-centered outcomes (diet quality, physical activity, home food environment, food security, quality of life, treatment satisfaction, self-efficacy, mood) at 3, 6, and 12 months postpartum. Key moderators (Black/White race, Hispanic/Non-Hispanic ethnicity, food security), and mediators (changes in weight, dietary quality, physical activity, and the home food environment) will be identified. The RE-AIM framework will guide an implementation process evaluation to plan for successful delivery and sustainment of the interventions. Findings from this from large scale, adequately powered trial of MtMs for maternal health will fill a major gap in the literature. If the MTM approach is found effective, there will be strong justification to bolster access (at state level) and referrals (within home visiting) to MtMs. Findings will inform tailored strategies to ensure successful sustainment in home visiting and reach for diverse pregnant and postpartum people with GDM.

Conditions

Diabetes Mellitus; Gestational Diabetes Mellitus (GDM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Usual Home Visiting plus GDM Enhanced

This group receives usual home visitation plus GDM Enhanced intervention.

Group Type: ACTIVE_COMPARATOR

GDM Enhanced

Intervention Type: 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

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

Group Type: EXPERIMENTAL

GDM Enhanced

Intervention Type: 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.

Meals

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lifespan/ The Miriam Hospital

UNKNOWN

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Bradley Hospital

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

California Polytechnic State University-San Luis Obispo

OTHER

Sponsor Role: lead

Responsible Party

Suzanne Phelan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne Phelan, PhD

Role: PRINCIPAL_INVESTIGATOR

California Polytechnic State University-San Luis Obispo

Locations

California Polytechnic State University

San Luis Obispo, California, United States

Northwestern University

Chicago, Illinois, United States

Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Central Contacts

Brooke Latzke-Davis, BS

Role: CONTACT

blatzked@calpoly.edu

805-756-5694

Facility Contacts

Suzanne Phelan, PhD

Role: primary

sphelan@calpoly.edu

8057562087

Darius Tandon, PhD

Role: primary

dtandon@northwestern.edu

410-852-0399

Rena R Wing, PhD

Role: primary

rwing@brownhealth.org

(401) 793-8959

Other Identifiers

MMM-2024C1-37760

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025-056

Identifier Type: -

Identifier Source: org_study_id