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

March 3, 2026 updated by: Suzanne Phelan, California Polytechnic State University-San Luis Obispo

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
978

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 93401
        • Recruiting
        • California Polytechnic State University
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern University
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Not yet recruiting
        • Miriam Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Home Visiting plus GDM Enhanced
This group receives usual home visitation plus GDM Enhanced intervention.
Behavioral: 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.
Experimental: Usual HV + GDM Enhanced + Meals
This group will receive usual home visitation plus GDM Enhanced plus medically tailored meals.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diabetes/Pre-Diabetes
Time Frame: From enrollment to 12 months postpartum
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1c concentration
Time Frame: From enrollment to 3, 6, and 12 months postpartum
HbA1c will be measured utilizing an at-home test kit (finger-stick, whole-blood test)
From enrollment to 3, 6, and 12 months postpartum
Systolic blood pressure
Time Frame: From enrollment to 3, 6, and 12 months postpartum
Systolic blood pressure will be self-measured in the home with trained research assistants guiding the assessment
From enrollment to 3, 6, and 12 months postpartum
Diastolic blood pressure
Time Frame: From enrollment to 3, 6, and 12 months postpartum
Diastolic blood pressure will be self-measured in the home with trained research assistants guiding the assessment
From enrollment to 3, 6, and 12 months postpartum
Body weight
Time Frame: From enrollment to 3, 6, and 12 months postpartum
Body weight is obtained using remote scales provided to participants.
From enrollment to 3, 6, and 12 months postpartum
Child zBMI
Time Frame: From 3 months to 6 and 12 months
Remote, guided parent measurements of child weight and length will be used to calculate the child's body mass index z-score (zBMI), along with parent-reported infant sex.
From 3 months to 6 and 12 months
Metabolic equivalent task minutes per week of moderate-to-vigorous physical activity
Time Frame: From enrollment to 3, 6, and 12 months postpartum
The International Physical Activity Questionnaire will be used to measure metabolic equivalent task (MET)-minutes per week of moderate-to-vigorous physical activity. Scores range from 0 to >10,000 MET-minutes/week, with higher scores indicating greater physical activity, which is considered a better outcome.
From enrollment to 3, 6, and 12 months postpartum
Home Food Environment
Time Frame: From enrollment to 3, 6, and 12 months postpartum
The home food environment checklist will be used to measure number of healthy foods in the home. Higher scores indicate a greater number of healthy foods present.
From enrollment to 3, 6, and 12 months postpartum
Food Security
Time Frame: From enrollment to 3, 6, and 12 months postpartum
The U.S. Household food security survey will be used to measure a categorical classification or high food security, marginal food security, low food security, and very low food security
From enrollment to 3, 6, and 12 months postpartum
Global Physical Health
Time Frame: From enrollment to 3, 6, and 12 months postpartum
The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10-item scale will be used to assess Global Physical Health (GPH). Raw scores are converted to T-scores, standardized to the U.S. general population (mean = 50, SD = 10). T-scores typically range from 20 to 80, with higher scores indicating better health.
From enrollment to 3, 6, and 12 months postpartum
Global Mental Health
Time Frame: From enrollment to 3, 6, and 12 months postpartum
The Patient-Reported Outcomes Measurement Information System Global Health 10-item scale will be used to assess Global Mental Health. Raw scores are converted to T-scores, standardized to the U.S. general population (mean = 50, SD = 10). T-scores typically range from 20 to 80, with higher scores indicating better health.
From enrollment to 3, 6, and 12 months postpartum
Nutrition Self-Efficacy
Time Frame: From enrollment to 3, 6, and 12 months postpartum
The Nutrition Self-Efficacy Scale will be used to assess participants' confidence in their ability to engage in healthy eating, yielding a continuous self-efficacy score. Each item is rated on a 5-point Likert scale from 1 (not at all confident) to 5 (very confident), resulting in a total score range of 10 to 50. Higher scores reflect greater self-efficacy for healthy eating behaviors
From enrollment to 3, 6, and 12 months postpartum
Center for Epidemiologic Studies Depression Scale
Time Frame: From enrollment to 3, 6, and 12 months postpartum
The Center for Epidemiologic Studies Depression Scale - 10-item version (CES-D-10) will be used to assess depressive symptoms. Each item is rated on a 4-point Likert scale from 0 (rarely or none of the time) to 3 (most or all of the time), yielding a total score range of 0 to 30. Higher scores indicate greater depressive symptomatology.
From enrollment to 3, 6, and 12 months postpartum
Barriers to Healthy Eating
Time Frame: From enrollment to 3, 6, and 12 months postpartum
Barriers to Healthy Eating Questionnaire is 14-items and assesses perceived barriers to healthy eating. The total score is calculated by summing all 14 items. Total scores range from 0 to 14, with higher scores reflecting greater overall perceived barriers to following a healthy eating pattern.
From enrollment to 3, 6, and 12 months postpartum
Diet quality
Time Frame: From enrollment to 3, 6, and 12 months postpartum
The Automated Self-Administered (ASA) 24-hour Recall of the National Cancer Institute will be used by trained staff to obtain an interview-based assessment of dietary quality. Healthy Eating Index (HEI) scores will be calculated by linking ASA24 output to the HEI scoring algorithm, which evaluates diet quality based on alignment with the Dietary Guidelines for Americans.Scores range from 0 to 100.
From enrollment to 3, 6, and 12 months postpartum

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention Measure
Time Frame: 12 months postpartum
The Feasibility of Intervention Measure will be used to assess participants' perceptions of how feasible the intervention is to implement. The scale includes 4 items, each rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree), resulting in a total score range of 4 to 20. Higher scores indicate greater perceived feasibility of the intervention.
12 months postpartum
Acceptability of Intervention Measure
Time Frame: 12 months postpartum
The Acceptability of Intervention Measure (AIM) will be used to assess participants' perceptions of how acceptable the intervention is. The measure includes 4 items, each rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree), resulting in a total score range of 4 to 20. Higher scores indicate greater acceptability of the intervention.
12 months postpartum
Intervention Appropriateness Measure
Time Frame: 12 months postpartum
The Intervention Appropriateness Measure (IAM) will be used to assess participants' perceptions of how suitable the intervention is. The scale consists of 4 items, each rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree), yielding a total score range of 4 to 20. Higher scores indicate greater perceived appropriateness of the intervention.
12 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
California Polytechnic State University-San Luis Obispo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
Northwestern University
Bradley Hospital
Lifespan/ The Miriam Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suzanne Phelan, PhD, California Polytechnic State University-San Luis Obispo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-056
  • MMM-2024C1-37760 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share de-identified individual participant data related to primary and secondary outcomes. These data may include measures of diabetes, physical activity, diet quality, and other health indicators.

IPD Sharing Time Frame

April, 2031

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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