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Behavioral Intervention

Food Prescription for Diabetes in Pregnancy

N/A

Recruiting

Led By Alison Gustafson, PhD

Research Sponsored by Alison Gustafson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post intervention, approximately 12 weeks

Awards & highlights

Study Summary

This trial will examine the effect of providing food prescription/medically tailored meals to pregnant women with GDM/T2DM to see if it improves their glucose control.

Who is the study for?

This trial is for pregnant women with gestational or type 2 diabetes, who experience food insecurity and live where Instacart delivers. They must have a device to order food online and not plan to move in the next three months. Non-English speakers are excluded.Check my eligibility

What is being tested?

The study tests if grocery prescriptions delivered via Instacart or frozen medically tailored meals from Door Dash can improve glucose control compared to standard care over 12 weeks in pregnant women with diabetes.See study design

What are the potential side effects?

There are no direct medical side effects discussed for this intervention as it involves dietary changes through prescribed groceries and tailored meals rather than medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post intervention, approximately 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post intervention, approximately 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post intervention, approximately 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage Change in fasting blood glucose

Secondary outcome measures

Change in blood pressure

Change in food insecurity

Change in self efficacy

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: MTM (medically tailored frozen meals)Experimental Treatment1 Intervention

Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash

Group II: Grocery Prescription ProgramExperimental Treatment1 Intervention

Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately

Group III: Standard Medical CareActive Control1 Intervention

the delayed control group will receive their usual care through their healthcare provider and then participate in Fresh Funds or MTM after the initial 12-weeks of intervention.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Instacart HealthUNKNOWN

1 Previous Clinical Trials

60 Total Patients Enrolled

Kentucky Association of Health PlansUNKNOWN

1 Previous Clinical Trials

60 Total Patients Enrolled

Alison GustafsonLead Sponsor

2 Previous Clinical Trials

460 Total Patients Enrolled

Media Library

Fresh Funds for Mom's (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05979519 — N/A

Type 2 Diabetes Research Study Groups: Grocery Prescription Program, Standard Medical Care, MTM (medically tailored frozen meals)

Type 2 Diabetes Clinical Trial 2023: Fresh Funds for Mom's Highlights & Side Effects. Trial Name: NCT05979519 — N/A

Fresh Funds for Mom's (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05979519 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible to partake in the study?

"The target candidates for this clinical trial must have gestational diabetes and be between 18 to 55 years old. Altogether, 120 individuals will need to partake in the study."

Answered by AI

Is the patient population for this trial restricted to adults aged 20 and above?

"Patients aged 18 to 55 are the only ones eligible for this trial. 192 studies exist pertaining to persons under 18 while 1139 relate to individuals over 65 years of age."

Answered by AI

Is this clinical investigation currently recruiting participants?

"Sadly, this medical study is no longer recruiting participants. As reported on clinicaltrials.gov, the trial was first posted August 1st 2023 and last updated July 28th 2023; however, 1482 other trials are still actively hunting for patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fresh Carts for Mom's to Improve Food Security and Glucose Management

Alison Gustafson 2023. "Fresh Carts for Mom's to Improve Food Security and Glucose Management". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05979519.