Food Order Intervention for Gestational Diabetes

Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus

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.

Study Overview

• Status: Terminated
• Conditions: Gestational Diabetes
• Intervention / Treatment: Behavioral: Food Order Therapy; Behavioral: Medical Nutrition Therapy

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Materal-Fetal Medicine of Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): March 19, 2020
• Study Completion (Actual): April 22, 2020

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 1802018956

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No