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

Study Overview
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Brief Summary
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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
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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: 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. 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.

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

Conditions
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Diabetes, Gestational

Intervention / Treatment
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* Behavioral: Dietary Intervention
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Human
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Intervention<br>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<br>* Individualized diet advice will be developed for each participant by a dietitian familiar with South Asian foods.<br>|
| Active Comparator: Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational diabetes mellitus | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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South Asian, diet