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

Tracking Information

• First Submitted Date: June 18, 2018
• First Posted Date: July 19, 2018
• Last Update Posted Date: November 23, 2020
• Actual Study Start Date: June 18, 2018
• Actual Primary Completion Date: March 19, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 17, 2018)

Feasibility of the Food Order Intervention [ Time Frame: 8 weeks ]

Measured via feasibility questionnaire.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Food Order Intervention for Gestational Diabetes
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gestational Diabetes

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 20, 2020): 28
• Original Estimated Enrollment (submitted: July 17, 2018): 40
• Actual Study Completion Date: April 22, 2020
• Actual Primary Completion Date: March 19, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03592784
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Weill Medical College of Cornell University
• Study Sponsor: Weill Medical College of Cornell University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Weill Medical College of Cornell University
• Verification Date: November 2020