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

Not Applicable

Recruiting

• Conditions: Diabetes, Gestational
• Interventions: Behavioral: Dietary Intervention; Behavioral: Control

• Registration Number: NCT03607799
• Lead Sponsor: McMaster University

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.

Detailed Description

The DESI-GDM study is a randomized study to assess the impact of a culturally tailored, personalized nutrition intervention on glycemic response to an oral glucose load in high-risk pregnancies of South Asian women. Eligible South Asian pregnant women will be randomized to intervention or control.

South Asians (SA), people whose ancestors are from India, Pakistan, Bangladesh, or Sri Lanka, are the largest non-white ethnic group in Canada, and are at high risk of type 2 diabetes mellitus (T2DM) and early cardiovascular disease (CVD). SA women have at least double the risk of gestational diabetes (GDM) of white European women, and risk factors for future T2DM in the offspring including higher birthweight, more adipose tissue, and reduced insulin sensitivity, are more common in SA infants of mothers with GDM than infants born to mothers without GDM.

Building on our findings from the South Asian prospective birth cohort (START), which identified diet as a key modifiable risk factor for GDM, we have developed a dietary intervention. The women we spoke with expressed a desire to learn more about healthy eating to prevent diabetes during pregnancy and were keen to use mobile health technology.

The objectives of this trial among pregnant women of South Asian descent are to:

1. Evaluate the effectiveness of a culturally-tailored personalized nutrition intervention delivered by a trained health coach to improve blood sugar levels in South Asian women to a greater extant than usual dietary advice.

2. Evaluate the effectiveness of a culturally-tailored personalized nutrition intervention delivered by a trained health coach to pregnant South Asian women in the reduction of the incidence of gestational diabetes mellitus to a greater extent than usual dietary advice.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-31
• Study Start: 2020-11-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 190

Inclusion Criteria

• pregnant

• South Asian ancestry

• gestational week 12-18

• singleton pregnancy

• at least 2 of the following:

  1. age > 29
  2. low diet quality (assessed with a short diet questionnaire)
  3. family history of type 2 diabetes in first-degree relative
  4. gestational diabetes during a previous pregnancy
  5. pre-pregnancy body-mass-index ≥23.17

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary Intervention	Dietary Intervention	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.
Control	Control	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.

Primary Outcome Measures

Name	Time	Method
Glucose area-under-the-curve (glucose AUC)	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Gestational diabetes mellitus	3 months	Gestational diabetes mellitus is classified using the cut-offs derived in a large cohort of South Asian women from the "Born in Bradford": fasting glucose level \>= 5.2 mmol/L, or 2-hour post-load level \>=7.2 mmol/L.

Trial Locations

Locations (1)

Farah Khan; 🇨🇦 Hamilton, Ontario, Canada