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

NCT03607799 | Active Not Recruiting

• 1 other identifier: 4886
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

South Asian; diet

Outcome Measures

Primary Outcomes (1)

• Glucose area-under-the-curve (glucose AUC)

  A measure of glycemic response, glucose AUC is a continuous measure of the response to a 75-g oral glucose tolerance test, and is calculated by the trapezoidal method using the fasting, 1-h, and 2-h glucose.

  3 months

Secondary Outcomes (1)

• Gestational diabetes mellitus

  3 months

Other Outcomes (2)

• Maternal blood pressure

  3 months

• Maternal pregnancy complications

  3 months

Study Arms (2)

Dietary Intervention

EXPERIMENTAL

A personalized nutrition plan will be developed for each woman and will respect faith-based food choices and regional preferences. The plan will be delivered by a culturally congruent health coach, and consider baseline dietary intake, energy balance for recommended gestational weight gain, personal values and preferences, through setting 2-4 "SMART" goals. Participants assigned to the intervention group will receive text messages. Participants assigned to the intervention group will be given a Fitbit to track their steps and will receive simple text messages weekly, aimed at increasing walking. They will be given PDF resources that provide advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the South Asian community.

Behavioral: Dietary Intervention

Control

ACTIVE COMPARATOR

Participants in the control group will receive simple text messages weekly, aimed at increasing walking. They will be given PDF resources that provide advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the South Asian community.

Behavioral: Control

Interventions

Dietary Intervention BEHAVIORAL

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

Dietary Intervention

Control BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant
• South Asian ancestry
• gestational week 12-18
• singleton pregnancy
• at least 2 of the following:
• age \> 29
• low diet quality (assessed with a short diet questionnaire)
• family history of type 2 diabetes in first-degree relative
• gestational diabetes during a previous pregnancy
• pre-pregnancy body-mass-index ≥23.17

You may not qualify if:

• type 1 or type 2 diabetes
• high blood pressure (\>140 mm Hg systolic or \>90 mm Hg diastolic)
• poor understanding of English
• unwillingness to modify diet
• at high risk of adverse pregnancy outcomes other than gestational diabetes (e.g. twins or higher-order multiples, use of fertility treatment(s), pre-existing hypertension, history of placenta previa or pre-term birth)
• enrollment in another study
• does not have a smartphone
• not willing to walk
• excessive nausea and/or vomiting

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator
• Population Health Research Institute: collaborator

Study Sites (1)

Farah Khan

Hamilton, Ontario, L8S4K1, Canada

Location

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MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Russell J de Souza, ScD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Those assessing the primary and secondary clinical outcomes are masked to treatment assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Human

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 31, 2018
• Study Start: November 26, 2020
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)