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

April 14, 2023 updated by: The University of Texas Medical Branch, Galveston

A Randomized Trial of a Low Carbohydrate Diet Versus the Current Recommended Dietary Guidelines to Improve Health Outcomes in Obese Postpartum Women

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.
Time Frame: Baseline, 3 months
Homeostatic model assessment for measurement of insulin sensitivity will be computed with fasting insulin and glucose levels (fasting for at least 8 hours) with the following calculation: (glucose x insulin/22.5). This calculation is measured in molar units (mmol/L).
Baseline, 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.
Time Frame: Baseline, 6 months
Homeostatic model assessment for measurement of insulin sensitivity will be computed with fasting insulin and glucose levels (fasting for at least 8 hours) with the following calculation: (glucose x insulin/22.5). This calculation is measured in molar units (mmol/L).
Baseline, 6 months
Change in weight measured in pounds.
Time Frame: Baseline, 3 months
The subject will be weighed at baseline and at 3 months.The weight will be calculated in pounds.
Baseline, 3 months
Change in weight measured in pounds.
Time Frame: Baseline, 6 months
The subject will be weighed at baseline and at 6 months. The weight will be calculated in pounds.
Baseline, 6 months
Development of diabetes postpartum as measured by 2 hour glucose tolerance test.
Time Frame: 3 months
As part of routine postpartum care, women at risk for diabetes have a glucose tolerance test performed within 3 months postpartum.
3 months
Change in blood pressure as measured by blood pressure cuff in mmHg.
Time Frame: Baseline, 3 months
The subject will have blood pressure checked at baseline and at 3 months. Blood pressure will be calculated in mmHg.
Baseline, 3 months
Change in blood pressure as measured by blood pressure cuff in mmHg.
Time Frame: Baseline, 6 months
The subject will have blood pressure checked at baseline and at 6 months. Blood pressure will be calculated in mmHg.
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara O Jacobs, MD, University of Texas
  • Principal Investigator: Antonio Saad, MD, University of Texas
  • Study Director: Ashley Salazar, WHNP, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-0314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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