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Nutrition Intervention

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

N/A

Recruiting

Led By Russell J de Souza, ScD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Unwillingness to modify diet

Excessive nausea and/or vomiting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will 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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a dietary intervention rather than medication, side effects are minimal but may include changes in digestion or food sensitivities as the participants adjust to new eating habits.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not willing to change my diet.

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I often feel very nauseous or vomit a lot.

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I have diabetes.

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I am not willing to walk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Gestational diabetes mellitus

Other study objectives

Maternal blood pressure

Maternal pregnancy complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Intervention

2014

Completed Phase 2

~2550

0 / 4Eligibility criteria met