Pregnant Patients at Risk of Gestational Diabetes
Conditions
Keywords
food insecurity, pregnancy, obesity, gestational diabetes, diabetes, insurance benefit design
Brief 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.
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the food delivery intervention- recruitment | 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 | 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 | Approximately 3 months (12 weeks) | Effectiveness is defined as the percent of successful deliveries. |
| Acceptability of the food delivery intervention for pregnant patients | 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. |
Countries
United States
Contacts
CONTACTCaitlyn Clock, MPH
CONTACTAlex Peahl, MD, MSc
PRINCIPAL_INVESTIGATORAlex Peahl
University of Michigan
Outcome results
None listed