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Food Order Intervention for Gestational Diabetes

NCT ID: NCT03592784

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-18

Study Completion Date

2020-04-22

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.

Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Food Order Therapy + Medical Nutrition Therapy

Group Type EXPERIMENTAL

Food Order Therapy

Intervention Type BEHAVIORAL

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

Medical Nutrition Therapy

Intervention Type 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.

Medical Nutrition Therapy Alone

Group Type ACTIVE_COMPARATOR

Medical Nutrition Therapy

Intervention Type 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.

Interventions

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Food Order Therapy

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

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alpana P Shukla, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Materal-Fetal Medicine of Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1802018956

Identifier Type: -

Identifier Source: org_study_id