No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
978 (estimated)
Sponsor
California Polytechnic State University-San Luis Obispo · Other
Who this trial is looking for
This trial is looking for pregnant individuals or those who have recently given birth and have been diagnosed with gestational diabetes. Participants will receive either enhanced lifestyle support along with meals or just enhanced lifestyle support to see how it helps reduce diabetes risk and improve health after birth.
Are You a Good Fit for This Trial?
You may be able to join if
I am currently in a home visiting program
I am pregnant or have given birth within the last 3 months
I have been diagnosed with gestational diabetes in my most recent pregnancy
I am 18 years old or older
I speak English or Spanish
I am not currently receiving medically tailored meals
I am willing to be placed in either treatment group
You may not be able to join if
I have been diagnosed with diabetes before this pregnancy
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The study is examining the health effects of gestational diabetes mellitus (GDM) intervention and medically tailored meals within home visiting. A large study is proposed that will include nearly a thousand pregnant or recently pregnant adults with recent GDM and who are from different regions and backgrounds. Two treatment approaches are compared, and both are in home visiting. One treatment grou…
The study is examining the health effects of gestational diabetes mellitus (GDM) intervention and medically tailored meals within home visiting. A large study is proposed that will include nearly a thousand pregnant or recently pregnant adults with recent GDM and who are from different regions and backgrounds. Two treatment approaches are compared, and both are in home visiting. One treatment group is receiving enhanced lifestyle support for GDM along with meals, and the other is receiving just the enhanced lifestyle support. The study will examine whether these interventions help reduce diabetes and pre-diabetes through 12 months postpartum, as well as other health factors like weight and blood pressure.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Currently in home visiting
* Pregnant or \< 3 months (13 weeks) postpartum
* Gestational Diabetes Mellitus diagnosis in most recent pregnancy (based on self-report)
* Aged 18 years or older
* English- or Spanish-speaking.
* Not currently being given medically tailored meals
* …
Inclusion Criteria:
* Currently in home visiting
* Pregnant or \< 3 months (13 weeks) postpartum
* Gestational Diabetes Mellitus diagnosis in most recent pregnancy (based on self-report)
* Aged 18 years or older
* English- or Spanish-speaking.
* Not currently being given medically tailored meals
* Willing to receive randomization to either group
Exclusion Criteria:
• Pre-existing diabetes (based on self-report)
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