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

Diabetes, Gestational Clinical Trial

— DESI-GDM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03607799
• Other study ID #: 4886
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: McMaster University
• Contact: Dipika Desai, MSc
• Phone: 9055212100
• Email: dipika.desai[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational

Intervention

Behavioral:
• Dietary Intervention
Individualized diet advice will be developed for each participant by a dietitian familiar with South Asian foods.
• 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.

Locations

Country	Name	City	State
Canada	Farah Khan	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation, Population Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (55)

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* Note: There are 55 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal blood pressure	We measure maternal blood pressure at baseline and the OGTT visit.	3 months
Other	Maternal pregnancy complications	Pregnancy complications will be noted at coaching contacts.	3 months
Primary	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	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