Lifestyle Interventions to Prevent Diabetes in U.S. Home Visiting Programs

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCalifornia Polytechnic State University-San Luis Obispo

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • GDM Enhanced
  • Meals

Treatment groups

978 Participants
are divided into 2 treatment groups

Sponsors and collaborators

California Polytechnic State University-San Luis Obispo

Lead sponsor

Lifespan/ The Miriam Hospital

Collaborator

Northwestern University

Collaborator

Bradley Hospital

Collaborator

Patient-Centered Outcomes Research Institute

Collaborator