Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Standard of care
Subjects will receive standard counseling on obesity as part of routine postpartum care.
Active Comparator
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.
  • Behavioral: Low carbohydrate diet education
    A 200 page informational document that connects with an online application will be provided to subjects.
  • Behavioral: 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.
Active Comparator
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.
  • Behavioral: Low carbohydrate diet education
    A 200 page informational document that connects with an online application will be provided to subjects.
  • Behavioral: 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.

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Sara O Jacobs, MD
409-772-1571
sojacobs@utmb.edu

More Details

NCT ID
NCT04045353
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Ashley Salazar, WHNP
409-772-0312
assalaza@utmb.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.