Food Order Intervention for Gestational Diabetes

NCT03592784 | Terminated

• 1 other identifier: 1802018956
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Food Order Intervention

  Measured via feasibility questionnaire.

  8 weeks

Secondary Outcomes (4)

• Average 1-hour postprandial glucose

  2, 4, 6, 8, 10, 12 weeks

• Time to initiation of pharmacotherapy

  2, 4, 6, 8, 10, 12 weeks

• Proportion of patients requiring the addition of pharmacotherapy

  Week 16 or End of study (at delivery)

• Birthweight

  Week 16 or End of study (delivery)

Study Arms (2)

Food Order Therapy + Medical Nutrition Therapy

EXPERIMENTAL

Behavioral: Food Order Therapy; Behavioral: Medical Nutrition Therapy

Medical Nutrition Therapy Alone

ACTIVE COMPARATOR

Behavioral: Medical Nutrition Therapy

Interventions

Food Order Therapy BEHAVIORAL

Instructing patient to, whenever possible, eat carbohydrates at the end of their meal.

Food Order Therapy + Medical Nutrition Therapy

Medical Nutrition Therapy BEHAVIORAL

Key components of this therapy include counseling to incorporate portion control, increased intake of vegetables and low glycemic index carbohydrates, and mild carbohydrate restriction.

Food Order Therapy + Medical Nutrition Therapy; Medical Nutrition Therapy Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Materal-Fetal Medicine of Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Alpana P Shukla, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 19, 2018
• Study Start: June 18, 2018
• Primary Completion: March 19, 2020
• Study Completion: April 22, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Locations

US (1)