TerminatedNot Applicable

A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth

Stopped: Unable to recruit subjects

United States11 participantsStarted 2019-12-20

Plain-language summary

The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Delivery at University of Texas Medical Branch * Body max index greater than or equal to 30 kilograms/meters squared at the final prenatal visit prior to delivery. * Singleton gestation. * Accessibility to the internet. * Basic understanding and comprehension of the English language to be assessed by study personnel at the time of recruitment. Exclusion Criteria: * Diabetes mellitus on medication. * Serious medical condition, such as heart failure, kidney failure, or severe asthma, as determined by the principle investigator. * Planned pregnancy during study period. * Enrolled in another trial that may affect outcome. * Subject unlikely to be followed up after delivery.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.

Timeframe: Baseline, 3 months

Trial details

NCT IDNCT04045353

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

View on ClinicalTrials.gov More Obesity trials