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Food Order Intervention for Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT03592784
Recruitment Status : Terminated (Lack of enrollment during Covid pandemic, however sufficient data gathered for assessment of primary outcome)
First Posted : July 19, 2018
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE June 18, 2018
First Posted Date  ICMJE July 19, 2018
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE June 18, 2018
Actual Primary Completion Date March 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
Feasibility of the Food Order Intervention [ Time Frame: 8 weeks ]
Measured via feasibility questionnaire.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
  • Average 1-hour postprandial glucose [ Time Frame: 2, 4, 6, 8, 10, 12 weeks ]
    Averaged from self-monitored blood glucose logs.
  • Time to initiation of pharmacotherapy [ Time Frame: 2, 4, 6, 8, 10, 12 weeks ]
    Measured in weeks from enrollment in the study.
  • 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.
  • Birthweight [ Time Frame: Week 16 or End of study (delivery) ]
    Measured in lbs.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Food Order Intervention for Gestational Diabetes
Official Title  ICMJE Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gestational Diabetes
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Food Order Therapy + Medical Nutrition Therapy
    Interventions:
    • Behavioral: Food Order Therapy
    • Behavioral: Medical Nutrition Therapy
  • Active Comparator: Medical Nutrition Therapy Alone
    Intervention: Behavioral: Medical Nutrition Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 20, 2020)
28
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2018)
40
Actual Study Completion Date  ICMJE April 22, 2020
Actual Primary Completion Date March 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03592784
Other Study ID Numbers  ICMJE 1802018956
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alpana P Shukla, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP