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

Part of paid clinical trials in San Luis Obispo, California.

Sponsor
California Polytechnic State University-San Luis Obispo
Study ID
NCT06988306
Status
Recruiting
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Conditions

  • Diabetes Mellitus
  • Gestational Diabetes Mellitus (GDM)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GDM Enhanced — BEHAVIORAL
    The GDM Enhanced intervention is comprised of HV-delivered, evidence-based modules (10-20 minutes) with facilitator guides. The content prioritizes management and prevention of diabetes through healthy eating, physical activity, and stigma-informed weight management strategies.
  • Meals — BEHAVIORAL
    The Meal intervention includes medically tailored meals being provided to participants starting after randomization and tailored to their individual dietary preferences and cultural considerations.

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
978 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Usual Home Visiting plus GDM Enhanced
    This group receives usual home visitation plus GDM Enhanced intervention.
  • Experimental: Usual HV + GDM Enhanced + Meals
    This group will receive usual home visitation plus GDM Enhanced plus medically tailored meals.

Primary Outcome Measure

Diabetes/Pre-Diabetes [ Time Frame: From enrollment to 12 months postpartum ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
California Polytechnic State UniversitySan Luis ObispoCalifornia93401
Suzanne Phelan, PhD
[email protected]
8057562087
Northwestern UniversityChicagoIllinois60611
Darius Tandon, PhD
[email protected]
410-852-0399
Miriam HospitalProvidenceRhode Island02906
Rena R Wing, PhD
[email protected]
(401) 793-8959

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California Polytechnic State University· San Luis Obispo, CANorthwestern University· Chicago, ILMiriam Hospital· Providence, RI

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