Food Order Intervention for Gestational Diabetes

Not Applicable

Terminated

• Conditions: Gestational Diabetes
• Interventions: Behavioral: Food Order Therapy; Behavioral: Medical Nutrition Therapy

• Registration Number: NCT03592784
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-18
• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-19
• Primary Completion: 2020-03-19
• Study Completion: 2020-04-22
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food Order Therapy + Medical Nutrition Therapy	Food Order Therapy	-
Medical Nutrition Therapy Alone	Medical Nutrition Therapy	-
Food Order Therapy + Medical Nutrition Therapy	Medical Nutrition Therapy	-

Primary Outcome Measures

Name	Time	Method
Feasibility of the Food Order Intervention	8 weeks	Measured via feasibility questionnaire.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Materal-Fetal Medicine of Weill Cornell Medicine; 🇺🇸 New York, New York, United States