A Culturally-tailored Personalized Nutrition Intervention in South Asian Women at Risk of Gestational Diabetes

NCT03607799 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-05-06

No results posted yet for this study

Summary

This trial will assess the impact of a culturally tailored, personalized nutrition intervention on glycemic response to an oral glucose load (as measured by the area-under-the curve glucose) in high-risk pregnancies of South Asian women. The intervention targets two at-risk individuals: mother and infant, "breaking the cycle" of maternal gestational dysglycemia, excess infant adiposity and insulin resistance, and CVD in both mother and baby. The findings of this study will be important in guiding future evidence-based recommendations and public health policies to manage gestational glycemia in pregnant women at risk of GDM.

Conditions

  • Diabetes, Gestational

Interventions

BEHAVIORAL

Dietary Intervention

Individualized diet advice will be developed for each participant by a dietitian familiar with South Asian foods.

BEHAVIORAL

Control

Control group participants will be provided with PDFs, website links to encourage healthy eating, physical activity, and other lifestyle factors during pregnancy. They will also receive weekly text messages aimed at increasing walking.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    collaborator OTHER
  • Population Health Research Institute

    collaborator OTHER
  • McMaster University

    lead OTHER

Principal Investigators

  • Russell J de Souza, ScD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-26
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03607799 on ClinicalTrials.gov