Gestational Diabetes Mellitus in PregnancyNCT05979519
Fresh Carts for Mom's to Improve Food Security and Glucose Management
A study testing Fresh Funds for Mom's, Standard Medical care and Medically Tailored Frozen Meals in people with Gestational Diabetes Mellitus in Pregnancy and Type 2 Diabetes Mellitus, run by Alison Gustafson at 2 sites in United States.
Trial summary
This study will look at the benefit of decreasing food insecurity and improving glucose control among women who either report gestational diabetes (GDM) at 20-28-weeks or have type 2 diabetes (T2DM) with a confirmed pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus
- What is being tested?
- Fresh Funds for Mom's, Standard Medical care and Medically Tailored Frozen Meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Sep 2023to 28 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of gestational diabetes or type 2 diabetes
- answer affirmative to one of two questions on the Hunger Vital Signs
- viable pregnancy
- lives in a service area of Instacart delivery
- has a phone or computer which allows ordering food for delivery
Who cannot join
- Does not speak English
- Does not have a phone, tablet, or computer to order groceries for Instacart
- Plans to move within the next 3 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40506
U of L Health
Louisville, Kentucky, 40202
About this study
This study will look at the benefit of decreasing food insecurity and improving glucose control among women who either report gestational diabetes (GDM) at 20-28-weeks or have type 2 diabetes (T2DM) with a confirmed pregnancy. Participants will receive a grocery prescription with delivery through Instacart at the start of the study or after 12 weeks or frozen medically tailored meals delivered from Door Dash. Researchers will compare the grocery prescription program, MTM (medically tailored meals), relative to standard of care to see if the impact on these food as medicine programs can improve glucose control over 12-weeks as compared to standard of care.
Read the detailed description
Women who have a diagnosis of gestational diabetes (GDM) or type 2 diabetes (T2DM) and who report food insecurity using the Hunger Vital Signs Screener will be recruited to participate in a comparative study across two urban communities. One arm will receive a grocery prescription program from Instacart Health to be spent on eligible healthy food items based on My Diabetes Plate. The other arm will receive 10 frozen medically tailored meals delivered to their door each week. The meals are based on diabetes guidelines and are culturally appropriate. Meals are created by a local nonprofit food pantry, Dare to Care, in Louisville, Kentucky and delivered via a partnership with Door Dash - Project Dash. Women will be recruited initially from a registered nurse who works at the clinic sites. The study team will then enroll participants after eligibility screening and conduct further onboarding into the food as medicine package based on locations.
- Being tested
- Fresh Funds for Mom's, Standard Medical care, Medically Tailored Frozen Meals
- Keywords
- Pregnancy, Food Insecurity, Food As Medicine
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Funds for Mom'sBehavioural
Also called Grocery Prescription Program; Food As Medicine
Participants will enroll in Instacart Fresh Funds program. Once enrolled participants will select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks.
Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks.
Standard Medical careBehavioural
Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks or be provided the medically tailored meals for 12 weeks.
Medically Tailored Frozen MealsBehavioural
Also called MTM; Food As Medicine
Participants will enroll in the MTM program. Once enrolled participants will receive 10 frozen meals delivered by Door Dash to their home each week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Grocery Prescription Program | Experimental | Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately Receives: Behavioral: Fresh Funds for Mom's |
| Standard Medical Care | Active comparator | 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. Receives: Behavioral: Standard Medical care |
| MTM (medically tailored frozen meals) | Experimental | Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash Receives: Behavioral: Medically Tailored Frozen Meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in fasting blood glucose
Fasting blood glucose obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart.
Measured: baseline and post intervention, approximately 12 weeks
Secondary outcomes (3)
Change in food insecurity
The USDA 6 item food insecurity screener will be used. The scale ranges from 0 to 6 with a higher score indicating greater food insecurity.
Measured: baseline and post intervention, approximately 12 weeks
Change in self efficacy
The self efficacy scale for diabetes measures the confidence in managing diabetes. Scores range from 1 to 10 with a higher score indicating greater confidence in managing diabetes.
Measured: baseline and post intervention, approximately 12 weeks
Change in blood pressure
Diastolic and systolic Blood pressure will be obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart.
Measured: baseline and post intervention, approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start26 Sep 2023
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alison Gustafson
- Sponsor type
- University, hospital or other
- Collaborators
- Instacart Health, Kentucky Association of Health Plans
- Responsible party
- Sponsor-investigator, Alison Gustafson, University of Kentucky
- Investigators
- Alison Gustafson, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979519
- Sponsor's protocol ID
- 86500
- Status last verified
- Jun 2024
- First submitted
- 28 Jul 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh Carts for Mom's to Improve Food Security and Glucose Management
- ClinicalTrials.gov ID
- NCT05979519
- Acronym / sponsor ID
- 86500
- Keywords
- Pregnancy, Food Insecurity, Food As Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Alison GustafsonUniversity, hospital or other
- Collaborators
- Instacart Health, Kentucky Association of Health Plans
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 7 Aug 2023 (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.
This study will look at the benefit of decreasing food insecurity and improving glucose control among women who either report gestational diabetes (GDM) at 20-28-weeks or have type 2 diabetes (T2DM) with a confirmed pregnancy. Participants will receive a grocery prescription with delivery through Instacart at the start of the study or after 12 weeks or frozen medically tailored meals delivered from Door Dash. Researchers will compare the grocery prescription program, MTM (medically tailored meals), relative to standard of care to see if the impact on these food as medicine programs can improve glucose control over 12-weeks as compared to standard of care.
Detailed description
Women who have a diagnosis of gestational diabetes (GDM) or type 2 diabetes (T2DM) and who report food insecurity using the Hunger Vital Signs Screener will be recruited to participate in a comparative study across two urban communities. One arm will receive a grocery prescription program from Instacart Health to be spent on eligible healthy food items based on My Diabetes Plate. The other arm will receive 10 frozen medically tailored meals delivered to their door each week. The meals are based on diabetes guidelines and are culturally appropriate. Meals are created by a local nonprofit food pantry, Dare to Care, in Louisville, Kentucky and delivered via a partnership with Door Dash - Project Dash. Women will be recruited initially from a registered nurse who works at the clinic sites. The study team will then enroll participants after eligibility screening and conduct further onboarding into the food as medicine package based on locations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grocery Prescription Program | Experimental | Behavioral: Fresh Funds for Mom'sThose randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately |
| Standard Medical Care | Active comparator | Behavioral: Standard Medical carethe 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. |
| MTM (medically tailored frozen meals) | Experimental | Behavioral: Medically Tailored Frozen MealsThose randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of gestational diabetes or type 2 diabetes
- answer affirmative to one of two questions on the Hunger Vital Signs
- viable pregnancy
- lives in a service area of Instacart delivery
- has a phone or computer which allows ordering food for delivery
Key exclusion criteria (3 listed)
- Does not speak English
- Does not have a phone, tablet, or computer to order groceries for Instacart
- Plans to move within the next 3 months
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 |
|---|---|---|
| Fresh Funds for Mom'sAlso: Grocery Prescription Program; Food As MedicineParticipants will enroll in Instacart Fresh Funds program. Once enrolled participants will select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks. Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks. | Behavioural | Grocery Prescription Program |
| Standard Medical careThose in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks or be provided the medically tailored meals for 12 weeks. | Behavioural | Standard Medical Care |
| Medically Tailored Frozen MealsAlso: MTM; Food As MedicineParticipants will enroll in the MTM program. Once enrolled participants will receive 10 frozen meals delivered by Door Dash to their home each week for 12 weeks. | Behavioural | MTM (medically tailored frozen meals) |
Primary outcome
Percentage Change in fasting blood glucose
Time frame: baseline and post intervention, approximately 12 weeks
Fasting blood glucose obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart.
3 secondary outcomes
Change in food insecurity
Time frame: baseline and post intervention, approximately 12 weeks
Change in self efficacy
Time frame: baseline and post intervention, approximately 12 weeks
Change in blood pressure
Time frame: baseline and post intervention, approximately 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes Mellitus in Pregnancy
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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. This study is not recruiting at the moment.
Alison Gustafson, PhD principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh Funds for Mom's, Standard Medical care and Medically Tailored Frozen Meals in people with Gestational Diabetes Mellitus in Pregnancy and Type 2 Diabetes Mellitus, run by Alison Gustafson at 2 sites 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in fasting blood glucose (time frame: baseline and post intervention, approximately 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2024.