Pregnant Patients at Risk of Gestational DiabetesNCT07800182
A Randomized Controlled Trial of Prepared vs. Unprepared Food
A study testing Prepared meals and Unprepared Pantry/Produce box in people with Pregnant Patients at Risk of Gestational Diabetes, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this study is to assess the feasibility of different food interventions, delivered through insurance providers, for addressing food insecurity in patients at risk of gestational diabetes (diabetes in pregnancy). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Patients at Risk of Gestational Diabetes
- What is being tested?
- Prepared meals and Unprepared Pantry/Produce box
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jul 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently pregnant at <24 weeks gestational age
- English-speaking
- Lives in Wayne County
- Engaged in Meridian-Case Management Program
- At least one risk factor for GDM as defined by ACOG OR diagnosis of Type 1/2 Diabetes:
- Overweight, obese, limited physical activity
Show all 14Show fewer
- Previous pregnancy with gestational diabetes
- Prior baby with macrosomia in a past pregnancy
- A very large baby in a previous birth (also known as macrosomia). This would be a baby bigger than 9 lbs 15 oz for diabetes or 11 lbs without diabetes.
- Hypertension, heart disease
- PCOS (polycystic ovarian syndrome)
- Prediabetes
- First degree relative with diabetes
- Member of a racial or ethnic group with a higher prevalence of diabetes (e.g., Black, Native American or Alaska Native, Asian, Hispanic/Latino or Pacific Islander
Who cannot join
- Unable to converse in English
- Not meeting the above criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alex Peahl, MD, MSc contact
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109
Caitlyn Clock, MPH, (734) 998-6485, cclock@med.umich.edu
Alex Peahl, MD
About this study
Official title: Prepared for Pregnancy: A Randomized Controlled Trial of Prepared vs. Unprepared Food
The goal of this study is to assess the feasibility of different food interventions, delivered through insurance providers, for addressing food insecurity in patients at risk of gestational diabetes (diabetes in pregnancy). Interventions include prepared food (fully prepared meals that participants can heat and eat) and unprepared food (boxes containing both fresh and shelf-stable items). The study will also assess the acceptability of food interventions for pregnant people.
- Being tested
- Prepared meals, Unprepared Pantry/Produce box
- Keywords
- food insecurity, pregnancy, obesity, gestational diabetes, diabetes, insurance benefit design
- Medical subject headings
- Obesity, Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prepared mealsBehavioural
The box is prepared meals and includes ready-to-heat meals from a diabetes-friendly menu, with some participant selection of meals after initial deliveries.
Unprepared Pantry/Produce boxBehavioural
The produce boxes include about 12 pounds of fresh fruits and vegetables. The pantry boxes include shelf-stable foods, and an allergen-friendly pantry box is available if needed. Unprepared food boxes will also include ideas for recipes using some of the items in the box.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Prepared Meals first | Experimental | Prepared meals (weeks 1-4), Unprepared Pantry/Produce boxes (weeks 5-12) Receives: Behavioral: Prepared meals; Behavioral: Unprepared Pantry/Produce box |
| Group B: Unprepared Pantry/Produce boxes first | Experimental | Unprepared Pantry/Produce boxes (weeks 1-8), Prepared meals (weeks 9-12) Receives: Behavioral: Prepared meals; Behavioral: Unprepared Pantry/Produce box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the food delivery intervention- recruitment
Feasibility will be assessed by individual recruitment of individuals into the study. Measure: Feasibility will be assessed by the number of participants recruited in 6 months. Success: recruitment of 40 participants.
Measured: 6 months (26 weeks)
Feasibility of the food delivery intervention - retention
Feasibility will be assessed by retention of individuals in the study. Measure: the number of participants engaged at 12 weeks post enrollment. Success: 60% indicating success.
Measured: Approximately 3 months (12 weeks)
Preliminary effectiveness of the food delivery intervention to improve access to healthy foods
Effectiveness is defined as the percent of successful deliveries.
Measured: Approximately 3 months (12 weeks)
Acceptability of the food delivery intervention for pregnant patients
Measured from self-report. Acceptability will be measured by percent of participants' positive responses on the Acceptability of Implementation Measure.
Measured: Approximately 4 months (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant Patients at Risk of Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Peahl, University of Michigan
- Investigators
- Alex Peahl, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800182
- Sponsor's protocol ID
- HUM00295794
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
PubMed 29370047
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepared for Pregnancy: A Randomized Controlled Trial of Prepared vs. Unprepared Food
- ClinicalTrials.gov ID
- NCT07800182
- Acronym / sponsor ID
- HUM00295794
- Keywords
- food insecurity, pregnancy, obesity, gestational diabetes, diabetes, insurance benefit design
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Sep 2026 (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 assess the feasibility of different food interventions, delivered through insurance providers, for addressing food insecurity in patients at risk of gestational diabetes (diabetes in pregnancy). Interventions include prepared food (fully prepared meals that participants can heat and eat) and unprepared food (boxes containing both fresh and shelf-stable items). The study will also assess the acceptability of food interventions for pregnant people.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Prepared Meals first | Experimental | Behavioral: Prepared meals, Behavioral: Unprepared Pantry/Produce boxPrepared meals (weeks 1-4), Unprepared Pantry/Produce boxes (weeks 5-12) |
| Group B: Unprepared Pantry/Produce boxes first | Experimental | Behavioral: Prepared meals, Behavioral: Unprepared Pantry/Produce boxUnprepared Pantry/Produce boxes (weeks 1-8), Prepared meals (weeks 9-12) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Currently pregnant at <24 weeks gestational age
- English-speaking
- Lives in Wayne County
- Engaged in Meridian-Case Management Program
- At least one risk factor for GDM as defined by ACOG OR diagnosis of Type 1/2 Diabetes:
Key exclusion criteria (2 listed)
- Unable to converse in English
- Not meeting the above criteria
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 |
|---|---|---|
| Prepared mealsThe box is prepared meals and includes ready-to-heat meals from a diabetes-friendly menu, with some participant selection of meals after initial deliveries. | Behavioural | Group A: Prepared Meals first, Group B: Unprepared Pantry/Produce boxes first |
| Unprepared Pantry/Produce boxThe produce boxes include about 12 pounds of fresh fruits and vegetables. The pantry boxes include shelf-stable foods, and an allergen-friendly pantry box is available if needed. Unprepared food boxes will also include ideas for recipes using some of the items in the box. | Behavioural | Group A: Prepared Meals first, Group B: Unprepared Pantry/Produce boxes first |
Primary outcome
Feasibility of the food delivery intervention- recruitment
Time frame: 6 months (26 weeks)
Feasibility will be assessed by individual recruitment of individuals into the study. Measure: Feasibility will be assessed by the number of participants recruited in 6 months. Success: recruitment of 40 participants.
Feasibility of the food delivery intervention - retention
Time frame: Approximately 3 months (12 weeks)
Feasibility will be assessed by retention of individuals in the study. Measure: the number of participants engaged at 12 weeks post enrollment. Success: 60% indicating success.
Preliminary effectiveness of the food delivery intervention to improve access to healthy foods
Time frame: Approximately 3 months (12 weeks)
Effectiveness is defined as the percent of successful deliveries.
Acceptability of the food delivery intervention for pregnant patients
Time frame: Approximately 4 months (16 weeks)
Measured from self-report. Acceptability will be measured by percent of participants' positive responses on the Acceptability of Implementation Measure.
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 2 Sep 2026.
- Background: PubMed 29370047ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
- Individual participant dataSharing planned: No
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.
Alex Peahl, MD, MSc contact
Alex Peahl principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prepared meals and Unprepared Pantry/Produce box in people with Pregnant Patients at Risk of Gestational Diabetes, run by University of Michigan 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 14 inclusion and 2 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: opening soon, as of the sponsor's last update on 2 Sep 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?
Contact Caitlyn Clock, MPH (734-998-6485, cclock@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the food delivery intervention- recruitment (time frame: 6 months (26 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07800182, which also lists 1 linked publication.
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 2 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.