ClinicalTrials.gg
Not yet recruitingNCT07800182Updated Sep 2, 2026

A Randomized Controlled Trial of Prepared vs. Unprepared Food

An interventional study of Prepared meals and Unprepared Pantry/Produce box in Pregnant Patients at Risk of Gestational Diabetes, sponsored by University of Michigan. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by University of Michigan · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 39 studies in Obesity by University of Michigan — 6 open to participants now, 7 under way, none of them phase 3. Obesity · University of Michigan.

Planned enrollment
18th of 35
40 · median 40
Started
2026
with 2 others
No phase
28 of 39
4 open now
Registered
39th of 39
by date

Among the 39 studies in Obesity by University of Michigan, this one is the 18th largest by planned enrollment of the 35 interventional ones that give a count, is one of 3 that started in 2026, is one of 28 with no phase, and was the 39th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

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Open to participants now

6 of the 39 studies in Obesity by University of Michigan are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study 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). 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.

03

Conditions studied

  • Pregnant Patients at Risk of Gestational Diabetes

Keywords

  • food insecurity
  • pregnancy
  • obesity
  • gestational diabetes
  • diabetes
  • insurance benefit design
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
    • 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

Exclusion criteria

Exclusion Criteria:

  • Unable to converse in English
  • Not meeting the above criteria
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Group A: Prepared Meals first

    Prepared meals (weeks 1-4), Unprepared Pantry/Produce boxes (weeks 5-12)

    Behavioral: Prepared meals · Behavioral: Unprepared Pantry/Produce box

  • Experimental
    Group B: Unprepared Pantry/Produce boxes first

    Unprepared Pantry/Produce boxes (weeks 1-8), Prepared meals (weeks 9-12)

    Behavioral: Prepared meals · Behavioral: Unprepared Pantry/Produce box

Interventions

  • BehavioralPrepared meals

    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.

  • BehavioralUnprepared Pantry/Produce box

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months (26 weeks)

  2. 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.

    Time frame: Approximately 3 months (12 weeks)

  3. Preliminary effectiveness of the food delivery intervention to improve access to healthy foods

    Effectiveness is defined as the percent of successful deliveries.

    Time frame: Approximately 3 months (12 weeks)

  4. 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.

    Time frame: Approximately 4 months (16 weeks)

07

Study locations

1 site
08

References and documents

Publications

  • ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. PubMed 29370047 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jul 2027, 10 months later.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 10 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2026
First posted
Sep 2, 2026
StartEst.
Sep 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07800182
Responsible party
Alex Peahl (Assistant Professor, Department of Obstetrics and Gynecology, University of Michigan) — Principal investigator
First posted
Sep 2, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Caitlyn Clock, MPH
Contact
cclock@med.umich.edu
734-998-6485
Alex Peahl, MD, MSc
Contact
alexfrie@med.umich.edu
Alex Peahl
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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