Food Order Intervention for Gestational Diabetes

Study Overview
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Brief Summary
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This is a randomized controlled feasibility trial for women diagnosed with gestational diabetes mellitus (GDM). The current front-line treatment for GDM is medical nutrition therapy (MNT), i.e. personalized diets which may or may not include mild carbohydrate restriction. Use of carbohydrate restriction increases the risk of the mother developing ketosis, a harmful condition for both the mother and fetus. If MNT is not enough to stabilize blood sugar levels, then pharmaceuticals are prescribed. In patients with type-2 diabetes and prediabetes, the carbohydrate-last food order behavior has been shown to improve post-meal blood sugar control without the need of reduced carbohydrate intake. Given this data, the addition of this intervention to MNT in patients with GDM may be helpful in achieving controlled blood sugar levels without increasing the risk of ketosis. This study will include two randomized groups diagnosed with GDM. Patients in the control group will be prescribed standard MNT. Patients in the intervention group will have identical MNT but with additional food order instruction/therapy. All patients will be followed up with at 1-2 week intervals. At each follow-up the physician and dietician will analyze the patient's blood sugar measurements and, among additional factors, determine if pharmaceuticals should be added. Treatment will continue through delivery. The primary aim of this study is to assess the feasibility of the carbohydrate last food order in GDM and generate preliminary data on its effects on glucose control.

Official Title
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Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Behavioral: Food Order Therapy
* Behavioral: Medical Nutrition Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant subjects ≥18 years old Newly diagnosed with GDM between 24-32 weeks of gestation with at least 2 days of self-monitored glucose logs or diagnosed via a 50g glucose challenge test (GCT) greater than 200mg/dL Exclusion Criteria: Pre-existing diabetes prior to conception Patients whom do not plan on consuming at least 3 meals daily throughout gestation (e.g. during Ramadan) Requirement of special medical diet (e.g. from phenylketonuria, celiac disease, etc.) History of bariatric surgery

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food Order Therapy + Medical Nutrition Therapy<br> | Behavioral: Food Order Therapy<br>* Instructing patient to, whenever possible, eat carbohydrates at the end of their meal.<br>Behavioral: Medical Nutrition Therapy<br>* Key components of this therapy include counseling to incorporate portion control, increased intake of vegetables and low glycemic index carbohydrates, and mild carbohydrate restriction.<br>|
| Active Comparator: Medical Nutrition Therapy Alone<br> | Behavioral: Medical Nutrition Therapy<br>* Key components of this therapy include counseling to incorporate portion control, increased intake of vegetables and low glycemic index carbohydrates, and mild carbohydrate restriction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the Food Order Intervention | Measured via feasibility questionnaire. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average 1-hour postprandial glucose | Averaged from self-monitored blood glucose logs. | 2, 4, 6, 8, 10, 12 weeks | 
| Time to initiation of pharmacotherapy | Measured in weeks from enrollment in the study. | 2, 4, 6, 8, 10, 12 weeks | 
| Proportion of patients requiring the addition of pharmacotherapy | Measured as a percentage of patients in each arm. | Week 16 or End of study (at delivery) | 
| Birthweight | Measured in lbs. | Week 16 or End of study (delivery) |