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A Randomized Controlled Trial of Prepared vs. Unprepared Food

Prepared for Pregnancy: A Randomized Controlled Trial of Prepared vs. Unprepared Food

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether insurance providers can offer heat-and-eat meals or boxes of fresh and long-lasting foods to help people who lack enough food. It is for pregnant people at risk for diabetes during pregnancy or who have type 1 or type 2 diabetes. It also asks how pregnant people feel about these food options.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are pregnant and less than 24 weeks along.
  • Speak English.
  • Live in Wayne County.
  • Take part in the Meridian Case Management Program.
  • Have type 1 or type 2 diabetes, OR at least one of the diabetes risk factors listed below.
  • Risk factors include being overweight, having obesity, getting little physical activity, or having had diabetes during a past pregnancy.
  • Risk factors also include high blood pressure, heart disease, PCOS (a hormone condition), prediabetes (blood sugar above normal), or a parent, sibling, or child with diabetes.
  • Other risk factors include a past baby weighing more than 9 lbs 15 oz with diabetes or 11 lbs without diabetes; or being in a group with higher diabetes rates, such as Black, Native American, Alaska Native, Asian, Hispanic/Latino, or Pacific Islander.

Who can't join

  • Cannot have a conversation in English.
  • Do not meet the requirements above.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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: * Unable to converse in English * Not meeting the above criteria

Study sites (1)

MI