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NCT04570111 · ClinicalTrials.gov registry record · NA

MOD Diet in Gestational Diabetes Mellitus

A NA study, sponsored by University of Kansas Medical Center.

Terminated
Registry status
NA
Development phase
6
Enrollment target

NCT04570111: Clinical Trial NA study, sponsored by University of Kansas Medical Center.

NCT04570111 is a NA study that was terminated before completion, run by University of Kansas Medical Center. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04570111, a NA study, was terminated before completion, sponsored by University of Kansas Medical Center.

TERMINATED
Registry status
NA
Development phase
6 participants
Enrollment target

Study 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. 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

Primary Outcome

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 subsca

Interventions

  • OTHER MOD Diet
  • OTHER Standard Care Diet

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2021-01-22
Est. Completion 2022-06-30
Phase NA
University of Kansas Medical Center

408 total trials

Why NCT04570111 stopped before completion

NCT04570111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which MOD Diet is the first listed.

NCT04570111 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04570111 about?

NCT04570111 is a clinical study titled "MOD Diet in 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...

What is the current status of trial NCT04570111?

This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2021-01-22. Estimated completion is 2022-06-30.

What interventions are being tested in trial NCT04570111?

The interventions under investigation include: MOD Diet (OTHER), Standard Care Diet (OTHER).

Who is sponsoring clinical trial NCT04570111?

This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04570111's enrollment target sits among peer trials

6 1983rd of 2000 higher than 13 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04570111, the US trial registry maintained by the National Library of Medicine. NCT04570111 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.