Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Feasibility of the Food Order Intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Food Order Therapy + Medical Nutrition Therapy
Intervention: Food Order Therapy (Behavioral)
Food Order Therapy + Medical Nutrition Therapy
Intervention: Medical Nutrition Therapy (Behavioral)
Medical Nutrition Therapy Alone
Intervention: Medical Nutrition Therapy (Behavioral)
Outcomes
Primary Outcomes
Feasibility of the Food Order Intervention
Time Frame: 8 weeks
Measured via feasibility questionnaire.
Secondary Outcomes
- 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))