Gestational DiabetesMODNCT04570111
MOD Diet in Gestational Diabetes Mellitus
A study testing MOD Diet in people with Gestational Diabetes, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Gestational diabetes (GDM) is a condition of high blood glucose (or "blood sugar") during pregnancy. GDM can cause harmful short-term and long-term health effects for mom and baby. Diet therapy is an effective way to achieve normal blood glucose for women with GDM, but the best diet is unknown. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- MOD Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 30 Jun 2022
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women between the ages 18-40 years old
- A positive GDM diagnosis at 24-28 weeks gestation
- GDM management by diet alone
- willing to consume food provided in the study
- English speaking
Who cannot join
- multiple gestation
- hypertriglyceridemia (fasting TG >400 mg/dL)
- suspected overt diabetes (previous A1c≥6.5)
- smoker
- fasting glucose >110mg/dL
- overt cognitive impairment
Show all 10Show fewer
- presence of risk factors for placental insufficiency or growth restriction (e.g.
- hypertension, renal disease, history of preeclampsia, use of β-blockers)
- history of preterm birth
- other major medical disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Modern Approach to Dietary Management of Gestational Diabetes Mellitus
Gestational diabetes (GDM) is a condition of high blood glucose (or "blood sugar") during pregnancy. GDM can cause harmful short-term and long-term health effects for mom and baby. Diet therapy is an effective way to achieve normal blood glucose for women with GDM, but the best diet is unknown. Diet strategies that improve blood glucose in GDM and that patients can follow are needed for better clinical care. In studies of non-pregnant individuals with diabetes, eating a high fat/protein breakfast as the only dietary change was enough to improve glucose control. Because highest blood glucose readings in GDM usually occur after breakfast, a high fat/protein breakfast could also improve glucose control in GDM. In this study, two dietary strategies for improving blood glucose will be compared. Ten women newly diagnosed with GDM (<30 weeks in pregnancy) will be enrolled in a 12-day cross-over controlled feeding study with a high fat/protein breakfast, which is named a 'Macro-Optimized Diet' (MOD) or standard care diet (SC). In other words, subjects will have all food provided to them, and they will consume each diet for a few days while researchers monitor their blood glucose. Most nutrition aspects of the two diets will be similar, but the MOD diet will vary the timing of eating carbohydrate, protein, and fat to achieve fewer carbs at breakfast. After the 12-day controlled feeding period, participants will continue one of the study diets (as randomized) until delivery. During this time, research team dietitians will provide personalized nutrition education to support GDM self-management. The study will evaluate whether the diet is acceptable to women with GDM and their clinic providers. Data to be collected include blood glucose data, patient and provider feedback on diet acceptability, weight gain, the number of participants who are prescribed blood glucose control medications, and infant weight. These data will be used to evaluate trends pointing to whether one diet is more effective.
Read the detailed description
Study Objectives: This research proposes to evaluate the feasibility of the proposed two-phased study: 1) compare two diet strategies to management of Gestational Diabetes Mellitus via a 12-day randomized cross-over feeding study, and 2) support patient self-management of assigned diet for remainder of pregnancy with clinical management team.
Study Type and Design:
- Type/Design: Single-center, randomized controlled cross-over feeding study
- Intervention and Control Procedures:
- Women between the ages of 18-40 years attending the University of Kansas Medical Center's high-risk clinic with a positive GDM diagnosis will be recruited.
- Randomization will occur after consent and will determine: 1) the first study diet for the 12-day cross-over controlled feeding, and 2) the 2nd study diet for the 12- day cross-over controlled feeding, which will be continued as the study diet for the remainder of pregnancy.
- All food will be provided to participants during the 12-day controlled feeding period. Consented women will report to the Clinical Research Center (CRC) on day 1 to collect venous blood samples and receive 2 days of wash-out diet. Participants will return on day 3 fasting for placement of the continuous glucose monitoring system (CGMS) and to collect 3 days of the first randomly assigned study diet (MOD or SC). On day 6, participants will return to the CRC fasting, provide a blood sample, and remove the CGMS. They will be served a breakfast for the first study diet, and hourly blood samples will be collected for 5 hours. After all blood samples have been collected, participants will receive wash-out diet meals/snacks through day 8. The same protocol will be repeated for days 9-12 for the alternative study diet (MOD or SC).
- At the completion of the 12-day cross-over controlled feeding study, participants will continue with the SC or MOD study diets (the last diet followed after randomization) to implement with registered dietitian (RD) support for the remainder of the pregnancy. Food will not be provided by the study team for this portion of the study. Standard care guidelines for dietetics practice in GDM recommend three visits with a registered dietitian. These visits will take place as as two face-to-face and two telephone encounters.
- Conditions
- Gestational Diabetes
- Being tested
- MOD Diet, Standard Care Diet
- Keywords
- diet therapy, patient education
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOD DietOther
The macro-optimized diet alters the timing of macronutrient intake to provide fewer carbohydrates at breakfast, while maintaining recommended amounts of macronutrients delivered throughout the course of the day
Standard Care DietOther
The standard care diet provides macronutrients within standard amounts (40% carbohydrate, 20% protein, 40% fat) at all meals and snacks per day.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Diet | Active comparator | After the controlled feeding study, participants in this group will follow the standard care diet for the remainder of pregnancy with the assistance of a study dietitian. The standard care study diet will provide the standard 40% Carb/20% Pro/40% Fat as energy, distributed consistently across 3 meals and 2 snacks. Receives: Other: Standard Care Diet |
| Macro-Optimized Diet (MOD) | Experimental | After the controlled feeding study, participants in this group will follow the MOD diet for the remainder of pregnancy with the assistance of a study dietitian. The MOD diet will differ from control by macronutrient distribution at breakfast specifically, but also at each eating occasion, although the daily macronutrient distribution is equal to the control diet. At breakfast, the MOD diet will provide 10% Carb/30% Pro/60% Fat. Receives: Other: MOD Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Satisfaction
Diet satisfaction will be measured by the Diet Satisfaction Questionnaire (James et al, 2018), a 28-item validated survey that measures diet satisfaction on 7 scales (healthy lifestyle, convenience, cost, family dynamics, preoccupation with food, negative aspects, and planning and preparation). Item statements are rated by participants on a 5-point Likert scale. Acceptability of both diets will be evaluated by degree of agreement with survey items using means +/- standard deviations for 7 subscales of diet satisfaction.
Measured: 18 months
Adherence to the study diet
Adherence to the study diet will be measured during both phases of the study. During the controlled feeding portion of the study, participants will log their % consumption of all meals and snacks and return logs to the research team. For the self-monitored phase, three multiple pass 24 hour dietary recalls will be collected by trained staff.
Macronutrient analysis of 24 hour recalls will be evaluated by eating occasion to determine diet adherence. Participants will also keep daily logs for food intake at breakfast. Logs will be sent weekly to the study team electronically. Adherence will be calculated as number of days meeting macronutrient goals at breakfast for both 24 hr recalls and logs. Participants will be considered adherent if meeting goal at least 75% of the time.
Measured: 18 months
Secondary outcomes (4)
Glucose Incremental area under the curve (iAUC)
iAUC measures glycemic excursions after meals and is calculated from glucose measurements using the trapezoid method38
Measured: 12 months
Prescription rates
Frequency of prescription of glucose lowering medication after study enrollment
Measured: 18 months
Gestational weight gain
Body weight gained between study enrollment and delivery.
Measured: 18 months
Infant weight
Infant weight at birth in grams
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start22 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: Inadequate number of eligible participants
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 University of Kansas Medical CenterThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather D Gibbs, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570111
- Sponsor's protocol ID
- 145905
- Acronym
- MOD
- Status last verified
- Sep 2022
- First submitted
- 17 Sep 2020
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modern Approach to Dietary Management of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04570111
- Acronym / sponsor ID
- MOD / 145905
- Conditions
- Gestational Diabetes
- Keywords
- diet therapy, patient education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate number of eligible participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 30 Sep 2020 (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.
Gestational diabetes (GDM) is a condition of high blood glucose (or "blood sugar") during pregnancy. GDM can cause harmful short-term and long-term health effects for mom and baby. Diet therapy is an effective way to achieve normal blood glucose for women with GDM, but the best diet is unknown. Diet strategies that improve blood glucose in GDM and that patients can follow are needed for better clinical care. In studies of non-pregnant individuals with diabetes, eating a high fat/protein breakfast as the only dietary change was enough to improve glucose control. Because highest blood glucose readings in GDM usually occur after breakfast, a high fat/protein breakfast could also improve glucose control in GDM. In this study, two dietary strategies for improving blood glucose will be compared. Ten women newly diagnosed with GDM (<30 weeks in pregnancy) will be enrolled in a 12-day cross-over controlled feeding study with a high fat/protein breakfast, which is named a 'Macro-Optimized Diet' (MOD) or standard care diet (SC). In other words, subjects will have all food provided to them, and they will consume each diet for a few days while researchers monitor their blood glucose. Most nutrition aspects of the two diets will be similar, but the MOD diet will vary the timing of eating carbohydrate, protein, and fat to achieve fewer carbs at breakfast. After the 12-day controlled feeding period, participants will continue one of the study diets (as randomized) until delivery. During this time, research team dietitians will provide personalized nutrition education to support GDM self-management. The study will evaluate whether the diet is acceptable to women with GDM and their clinic providers. Data to be collected include blood glucose data, patient and provider feedback on diet acceptability, weight gain, the number of participants who are prescribed blood glucose control medications, and infant weight. These data will be used to evaluate trends pointing to whether one diet is more effective.
Detailed description
Study Objectives: This research proposes to evaluate the feasibility of the proposed two-phased study: 1) compare two diet strategies to management of Gestational Diabetes Mellitus via a 12-day randomized cross-over feeding study, and 2) support patient self-management of assigned diet for remainder of pregnancy with clinical management team.
Study Type and Design:
- Type/Design: Single-center, randomized controlled cross-over feeding study
- Intervention and Control Procedures:
- Women between the ages of 18-40 years attending the University of Kansas Medical Center's high-risk clinic with a positive GDM diagnosis will be recruited.
- Randomization will occur after consent and will determine: 1) the first study diet for the 12-day cross-over controlled feeding, and 2) the 2nd study diet for the 12- day cross-over controlled feeding, which will be continued as the study diet for the remainder of pregnancy.
- All food will be provided to participants during the 12-day controlled feeding period. Consented women will report to the Clinical Research Center (CRC) on day 1 to collect venous blood samples and receive 2 days of wash-out diet. Participants will return on day 3 fasting for placement of the continuous glucose monitoring system (CGMS) and to collect 3 days of the first randomly assigned study diet (MOD or SC). On day 6, participants will return to the CRC fasting, provide a blood sample, and remove the CGMS. They will be served a breakfast for the first study diet, and hourly blood samples will be collected for 5 hours. After all blood samples have been collected, participants will receive wash-out diet meals/snacks through day 8. The same protocol will be repeated for days 9-12 for the alternative study diet (MOD or SC).
- At the completion of the 12-day cross-over controlled feeding study, participants will continue with the SC or MOD study diets (the last diet followed after randomization) to implement with registered dietitian (RD) support for the remainder of the pregnancy. Food will not be provided by the study team for this portion of the study. Standard care guidelines for dietetics practice in GDM recommend three visits with a registered dietitian. These visits will take place as as two face-to-face and two telephone encounters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Diet | Active comparator | Other: Standard Care DietAfter the controlled feeding study, participants in this group will follow the standard care diet for the remainder of pregnancy with the assistance of a study dietitian. The standard care study diet will provide the standard 40% Carb/20% Pro/40% Fat as energy, distributed consistently across 3 meals and 2 snacks. |
| Macro-Optimized Diet (MOD) | Experimental | Other: MOD DietAfter the controlled feeding study, participants in this group will follow the MOD diet for the remainder of pregnancy with the assistance of a study dietitian. The MOD diet will differ from control by macronutrient distribution at breakfast specifically, but also at each eating occasion, although the daily macronutrient distribution is equal to the control diet. At breakfast, the MOD diet will provide 10% Carb/30% Pro/60% Fat. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women between the ages 18-40 years old
- A positive GDM diagnosis at 24-28 weeks gestation
- GDM management by diet alone
- willing to consume food provided in the study
- English speaking
Key exclusion criteria (10 listed)
- multiple gestation
- hypertriglyceridemia (fasting TG >400 mg/dL)
- suspected overt diabetes (previous A1c≥6.5)
- smoker
- fasting glucose >110mg/dL
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 |
|---|---|---|
| MOD DietThe macro-optimized diet alters the timing of macronutrient intake to provide fewer carbohydrates at breakfast, while maintaining recommended amounts of macronutrients delivered throughout the course of the day | Other | Macro-Optimized Diet (MOD) |
| Standard Care DietThe standard care diet provides macronutrients within standard amounts (40% carbohydrate, 20% protein, 40% fat) at all meals and snacks per day. | Other | Standard Care Diet |
Primary outcome
Diet Satisfaction
Time frame: 18 months
Diet satisfaction will be measured by the Diet Satisfaction Questionnaire (James et al, 2018), a 28-item validated survey that measures diet satisfaction on 7 scales (healthy lifestyle, convenience, cost, family dynamics, preoccupation with food, negative aspects, and planning and preparation). Item statements are rated by participants on a 5-point Likert scale. Acceptability of both diets will be evaluated by degree of agreement with survey items using means +/- standard deviations for 7 subscales of diet satisfaction.
Adherence to the study diet
Time frame: 18 months
Adherence to the study diet will be measured during both phases of the study. During the controlled feeding portion of the study, participants will log their % consumption of all meals and snacks and return logs to the research team. For the self-monitored phase, three multiple pass 24 hour dietary recalls will be collected by trained staff. Macronutrient analysis of 24 hour recalls will be evaluated by eating occasion to determine diet adherence. Participants will also keep daily logs for food intake at breakfast. Logs will be sent weekly to the study team electronically. Adherence will be calculated as number of days meeting macronutrient goals at breakfast for both 24 hr recalls and logs. Participants will be considered adherent if meeting goal at least 75% of the time.
4 secondary outcomes
Glucose Incremental area under the curve (iAUC)
Time frame: 12 months
Prescription rates
Time frame: 18 months
Gestational weight gain
Time frame: 18 months
Infant weight
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Inadequate number of eligible participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Heather D Gibbs, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOD Diet in people with Gestational Diabetes, run by University of Kansas Medical Center 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 5 inclusion and 10 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 10 Sep 2022. 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: Inadequate number of eligible participants). 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?
Diet Satisfaction (time frame: 18 months). The study lists 2 primary outcomes in all. 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 10 Sep 2022.