Personalized Nutrition Intervention for Gestational Diabetes
(DESI-GDM Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byRussell J de Souza, ScD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for South Asian women between 12-18 weeks pregnant, at risk of gestational diabetes due to factors like age over 29, poor diet, family history of diabetes, or previous gestational diabetes. They must have a single pregnancy and be willing to modify their diet.

Inclusion Criteria

You are pregnant with only one baby.

I am over 29, have a poor diet, a family history of diabetes, had gestational diabetes, or my BMI is over 23.17.

You are currently pregnant and have ancestors from South Asia.

+1 more

Exclusion Criteria

I often feel very nauseous or vomit a lot.

I am not willing to change my diet.

You have a higher chance of having complications during pregnancy, like having twins, using fertility treatments, or having certain health conditions.

+6 more

Participant Groups

The study tests a personalized nutrition plan tailored to cultural preferences against a control group with standard advice. It aims to see if the special diet can improve blood sugar levels after an oral glucose test in both mother and infant.

2Treatment groups

Experimental Treatment

Active Control

Group I: Dietary InterventionExperimental Treatment1 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.

Group II: ControlActive Control1 Intervention

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.