Gestational DiabetesNCT03592784
Food Order Intervention for Gestational Diabetes
A study testing Food Order Therapy and Medical Nutrition Therapy in people with Gestational Diabetes, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Food Order Therapy and Medical Nutrition Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2018to 22 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Materal-Fetal Medicine of Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus
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
- Being tested
- Food Order Therapy, Medical Nutrition Therapy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Order TherapyBehavioural
Instructing patient to, whenever possible, eat carbohydrates at the end of their meal.
Medical Nutrition TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Food Order Therapy + Medical Nutrition Therapy | Experimental | Not described Receives: Behavioral: Food Order Therapy; Behavioral: Medical Nutrition Therapy |
| Medical Nutrition Therapy Alone | Active comparator | Not described Receives: Behavioral: Medical Nutrition Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Food Order Intervention
Measured via feasibility questionnaire.
Measured: 8 weeks
Secondary outcomes (4)
Average 1-hour postprandial glucose
Averaged from self-monitored blood glucose logs.
Measured: 2, 4, 6, 8, 10, 12 weeks
Time to initiation of pharmacotherapy
Measured in weeks from enrollment in the study.
Measured: 2, 4, 6, 8, 10, 12 weeks
Proportion of patients requiring the addition of pharmacotherapy
Measured as a percentage of patients in each arm.
Measured: Week 16 or End of study (at delivery)
Birthweight
Measured in lbs.
Measured: Week 16 or End of study (delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start18 Jun 2018
- Primary completion19 Mar 2020
- Study completion22 Apr 2020
Why it stopped: Lack of enrollment during Covid pandemic, however sufficient data gathered for assessment of primary outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alpana P Shukla, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592784
- Sponsor's protocol ID
- 1802018956
- Status last verified
- Nov 2020
- First submitted
- 18 Jun 2018
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03592784
- Acronym / sponsor ID
- 1802018956
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment during Covid pandemic, however sufficient data gathered for assessment of primary outcome
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Order TherapyInstructing patient to, whenever possible, eat carbohydrates at the end of their meal. | Behavioural | Food Order Therapy + Medical Nutrition Therapy |
| Medical Nutrition TherapyKey components of this therapy include counseling to incorporate portion control, increased intake of vegetables and low glycemic index carbohydrates, and mild carbohydrate restriction. | Behavioural | Food Order Therapy + Medical Nutrition Therapy, Medical Nutrition Therapy Alone |
Primary outcome
Feasibility of the Food Order Intervention
Time frame: 8 weeks
Measured via feasibility questionnaire.
4 secondary outcomes
Average 1-hour postprandial glucose
Time frame: 2, 4, 6, 8, 10, 12 weeks
Time to initiation of pharmacotherapy
Time frame: 2, 4, 6, 8, 10, 12 weeks
Proportion of patients requiring the addition of pharmacotherapy
Time frame: Week 16 or End of study (at delivery)
Birthweight
Time frame: Week 16 or End of study (delivery)
Results and safety
The study was stopped early (reason given: Lack of enrollment during Covid pandemic, however sufficient data gathered for assessment of primary outcome). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alpana P Shukla, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Order Therapy and Medical Nutrition Therapy in people with Gestational Diabetes, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment during Covid pandemic, however sufficient data gathered for assessment of primary outcome). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Food Order Intervention (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.