Lifestyle Interventions for Gestational Diabetes

Recruiting at 2 trial locations

Overseen By Noemi Alarcon, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: California Polytechnic State University-San Luis Obispo

Disqualifiers: Pre-existing diabetes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

978 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Suzanne Phelan, PhD

Principal Investigator

California Polytechnic State University-San Luis Obispo

Eligibility Criteria

This trial is for nearly a thousand pregnant or recently pregnant adults with recent gestational diabetes mellitus (GDM), from various regions and backgrounds. The study aims to see if certain lifestyle interventions can prevent diabetes postpartum.

Inclusion Criteria

Pregnant or less than 3 months (13 weeks) postpartum

Currently in home visiting

Not currently being given medically tailored meals

Exclusion Criteria

Pre-existing diabetes (based on self-report)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either GDM Enhanced lifestyle intervention plus medically tailored meals or GDM Enhanced Only within home visiting

12 months

Regular home visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of glucose tolerance, weight, blood pressure, and other health factors

12 months

Assessments at 3, 6, and 12 months postpartum

Treatment Details

Interventions

• GDM Enhanced
• Meals

Trial Overview The study compares two treatments: one group receives enhanced lifestyle support for GDM plus medically tailored meals, while the other gets just the enhanced lifestyle support. It will track effects on diabetes prevention, weight, and blood pressure up to 12 months after giving birth.

Participant Groups

Group I: Usual HV + GDM Enhanced + Meals Experimental Treatment 2 Interventions

This group will receive usual home visitation plus GDM Enhanced plus 6 months of medically tailored meals.

Group II: Usual Home Visiting plus GDM Enhanced Active Control 1 Intervention

This group receives usual home visitation plus GDM Enhanced intervention.

Who Is Running the Clinical Trial?

California Polytechnic State University-San Luis Obispo

Lead Sponsor

Trials

33

Recruited

3,400+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Lifespan/ The Miriam Hospital

Collaborator

Trials

1

Recruited

260+

Bradley Hospital

Collaborator

Trials

22

Recruited

1,900+