- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04570111
MOD Diet in Gestational Diabetes Mellitus (MOD)
A Modern Approach to Dietary Management of Gestational Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- multiple gestation
- hypertriglyceridemia (fasting TG >400 mg/dL)
- suspected overt diabetes (previous A1c≥6.5)
- smoker
- fasting glucose >110mg/dL
- overt cognitive impairment
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Standard Care Diet
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.
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The standard care diet provides macronutrients within standard amounts (40% carbohydrate, 20% protein, 40% fat) at all meals and snacks per day.
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EXPERIMENTAL: Macro-Optimized Diet (MOD)
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diet Satisfaction
Time Frame: 18 months
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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.
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18 months
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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. |
18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Incremental area under the curve (iAUC)
Time Frame: 12 months
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iAUC measures glycemic excursions after meals and is calculated from glucose measurements using the trapezoid method38
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12 months
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Prescription rates
Time Frame: 18 months
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Frequency of prescription of glucose lowering medication after study enrollment
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18 months
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Gestational weight gain
Time Frame: 18 months
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Body weight gained between study enrollment and delivery.
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18 months
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Infant weight
Time Frame: 18 months
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Infant weight at birth in grams
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18 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Heather D Gibbs, PhD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 145905
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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