Food Order Intervention for Gestational Diabetes

• ClinicalTrials.gov Identifier: NCT03592784
• Recruitment Status: Terminated
• First Posted: July 19, 2018
• Last Update Posted: November 23, 2020
• Sponsor: Weill Medical College of Cornell University
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Gestational Diabetes	Behavioral: Food Order Therapy; Behavioral: Medical Nutrition Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus
• Actual Study Start Date: June 18, 2018
• Actual Primary Completion Date: March 19, 2020
• Actual Study Completion Date: April 22, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of the Food Order Intervention [ Time Frame: 8 weeks ]
   Measured via feasibility questionnaire.

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New York

Materal-Fetal Medicine of Weill Cornell Medicine

New York, New York, United States, 10065

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

• Principal Investigator: Alpana P Shukla, MD; Weill Medical College of Cornell University

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03592784
• Other Study ID Numbers: 1802018956
• First Posted: July 19, 2018
• Last Update Posted: November 23, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes, Gestational; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications