A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth
NCT ID: NCT04045353
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
11 participants
INTERVENTIONAL
2019-12-20
2022-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Thermic & Lipemic Properties of Dietary Carbohydrates
NCT01354574
Clinical Study to Test the Effects of a Low-Carbohydrate Diet on Body Weight
NCT00351845
Feasibility of Meal Delivery Postpartum
NCT05579990
Achieving Energy Balance in Post Partum Teens
NCT01617486
Giving a Low Carbohydrate Diet to Overcome Hypertension
NCT04230928
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of care
Subjects will receive standard counseling on obesity as part of routine postpartum care.
No interventions assigned to this group
Low carbohydrate diet education
Subjects will receive educational materials regarding a low carbohydrate diet in addition to the standard counseling on obesity as part of routine postpartum care.
Low carbohydrate diet education
A 200 page informational document that connects with an online application will be provided to subjects.
Low carbohydrate diet education with behavioral component
Subjects will receive in person instruction regarding a low carbohydrate diet as part of a 12 week course, in addition to receiving educational materials regarding a low carbohydrate diet and the standard counseling on obesity as part of routine postpartum care.
Low carbohydrate diet education
A 200 page informational document that connects with an online application will be provided to subjects.
Low carbohydrate diet education with behavioral component
A 12 week course taught be a certified instructor will teach subjects about a low carbohydrate document. Subjects will also be given a 200 page informational document that connects with an online application.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low carbohydrate diet education
A 200 page informational document that connects with an online application will be provided to subjects.
Low carbohydrate diet education with behavioral component
A 12 week course taught be a certified instructor will teach subjects about a low carbohydrate document. Subjects will also be given a 200 page informational document that connects with an online application.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sara O Jacobs, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Antonio Saad, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Ashley Salazar, WHNP
Role: STUDY_DIRECTOR
University of Texas
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Texas Medical Branch
Galveston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Morkrid K, Jenum AK, Sletner L, Vardal MH, Waage CW, Nakstad B, Vangen S, Birkeland KI. Failure to increase insulin secretory capacity during pregnancy-induced insulin resistance is associated with ethnicity and gestational diabetes. Eur J Endocrinol. 2012 Oct;167(4):579-88. doi: 10.1530/EJE-12-0452. Epub 2012 Aug 13.
Rooney BL, Schauberger CW. Excess pregnancy weight gain and long-term obesity: one decade later. Obstet Gynecol. 2002 Aug;100(2):245-52. doi: 10.1016/s0029-7844(02)02125-7.
Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90. doi: 10.1056/NEJMoa022207.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-0314
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.