Gestational DiabetesPLATENCT06320054
Preventing Obstetric Complications With Dietary Intervention
A study testing Maternal Health Management Program in people with Gestational Diabetes and Gestational Hypertension, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Gestational Hypertension, High Risk Pregnancy
- What is being tested?
- Maternal Health Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age at enrollment ≥ 18 years of age
- Receiving prenatal care at Froedtert
- ≤ 16 weeks and 6 days of gestation
- At risk of preeclampsia, defined as being eligible for low dose aspirin treatment AND/OR at risk for gestational diabetes defined as having a history of gestational diabetes, OR previously given birth to an infant weighing ≥ 4000 g, OR has a diagnosis of PCOS
- Pre-pregnancy Body Mass Index ≥ 25 kg/m^2
- Resides in Milwaukee County at time of consent
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- Low socio-economic status (<200% of FPL defined as receiving Medicaid)
- Able to read and communicate in English
- Has access to a smart device/computer with reliable internet connection
- Has access to a working refrigerator
- Viable singleton pregnancy
Who cannot join
- Diagnosed with Type I or Type II Diabetes or Hemoglobin A1C ≥ 6.5%
- Diagnosed with End Stage Renal Disease
- Use of weight-increasing psychotropic agents
- Active inflammatory bowel disease, or history of bowel resection or malabsorptive syndrome, or history of bariatric surgery
- Significant food allergies, preferences or dietary requirements that would interfere with diet adherence
- Multifetal gestation
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- Active substance use that would preclude program adherence
- Chronic use of oral corticosteroids
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedert & The Medical College of Wiscosin
Milwaukee, Wisconsin, 53226
About this study
Official title: Preventing Common Obstetric Complications Through an Immersive, Medically Tailored Meal Program
The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:
- Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns?
- Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups.
Read more
Participants in the standard of care will be asked to:
- Complete surveys
- Biometric screenings
Participants in the intervention group will be asked to:
- Complete surveys
- Biometric screenings
- Participate in weekly personal health coaching
- Receive and consume provided weekly meals.
Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.
- Being tested
- Maternal Health Management Program
- Medical subject headings
- Diabetes, Gestational, Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Health Management ProgramBehavioural
Program participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change.
| Study group | Role | What they receive |
|---|---|---|
| Standard Prenatal Care | No intervention | Standard Prenatal Care, biometric screenings, and surveys (baseline, 4-12 weeks postpartum). |
| Maternal Health Management Program | Experimental | Program participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change. Receives: Behavioral: Maternal Health Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes
gestational weight gain (BMI early pregnancy in comparison to BMI at delivery)
Measured: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Clinical Outcomes
blood pressure (Compared to early pregnancy, intrapartum, postpartum
Measured: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Clinical Outcomes
Diagnosis of gestational diabetes
Measured: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Clinical Outcomes
Diagnosis of preeclampsia or gestational hypertension
Measured: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Clinical Outcomes
Gestational age at birth (Weeks and Days)
Measured: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Secondary outcomes (5)
Patient Reported Outcomes
program utilization (measured by percentage of weekly coaching attended and number of meals consumed)
Measured: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes
participant satisfaction and retention (measured by end of study evaluation)
Measured: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes
self-efficacy skills with meals preparation (as measured by nutrition survey)
Measured: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes
physical activity planning (as measured by physical activity survey)
Measured: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes
Self-Efficacy (as measure by Self-Efficacy survey)
Measured: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start12 Jun 2024
- Primary completion28 May 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Advancing a Healthier Wisconsin Endowment, Food for Health, Inc.
- Responsible party
- Principal investigator, Anna Palatnik, MD, Medical College of Wisconsin
- Investigators
- Anna Palatnik, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320054
- Sponsor's protocol ID
- PRO00049771
- Acronym
- PLATE
- Status last verified
- May 2026
- First submitted
- 5 Mar 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Common Obstetric Complications Through an Immersive, Medically Tailored Meal Program
- ClinicalTrials.gov ID
- NCT06320054
- Acronym / sponsor ID
- PLATE / PRO00049771
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Advancing a Healthier Wisconsin Endowment, Food for Health, Inc.
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:
- Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns?
- Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups.
Participants in the standard of care will be asked to:
- Complete surveys
- Biometric screenings
Participants in the intervention group will be asked to:
- Complete surveys
- Biometric screenings
- Participate in weekly personal health coaching
- Receive and consume provided weekly meals.
Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Prenatal Care | No intervention | –Standard Prenatal Care, biometric screenings, and surveys (baseline, 4-12 weeks postpartum). |
| Maternal Health Management Program | Experimental | Behavioral: Maternal Health Management ProgramProgram participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age at enrollment ≥ 18 years of age
- Receiving prenatal care at Froedtert
- ≤ 16 weeks and 6 days of gestation
- At risk of preeclampsia, defined as being eligible for low dose aspirin treatment AND/OR at risk for gestational diabetes defined as having a history of gestational diabetes, OR previously given birth to an infant weighing ≥ 4000 g, OR has a diagnosis of PCOS
- Pre-pregnancy Body Mass Index ≥ 25 kg/m^2
Key exclusion criteria (9 listed)
- Diagnosed with Type I or Type II Diabetes or Hemoglobin A1C ≥ 6.5%
- Diagnosed with End Stage Renal Disease
- Use of weight-increasing psychotropic agents
- Active inflammatory bowel disease, or history of bowel resection or malabsorptive syndrome, or history of bariatric surgery
- Significant food allergies, preferences or dietary requirements that would interfere with diet adherence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal Health Management ProgramProgram participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change. | Behavioural | Maternal Health Management Program |
Primary outcome
Clinical Outcomes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
gestational weight gain (BMI early pregnancy in comparison to BMI at delivery)
Clinical Outcomes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
blood pressure (Compared to early pregnancy, intrapartum, postpartum
Clinical Outcomes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Diagnosis of gestational diabetes
Clinical Outcomes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Diagnosis of preeclampsia or gestational hypertension
Clinical Outcomes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Gestational age at birth (Weeks and Days)
5 secondary outcomes
Patient Reported Outcomes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Patient Reported Outcomes
Time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Palatnik, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Health Management Program in people with Gestational Diabetes and Gestational Hypertension, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcomes (time frame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.