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

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: Terminated
• Conditions: Obesity; Insulin Sensitivity; Postpartum Weight Retention
• Intervention / Treatment: Behavioral: Low carbohydrate diet education; Behavioral: Low carbohydrate diet education with behavioral component

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.	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

Outcome Measure	Measure Description	Time Frame
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.	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.	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.	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.	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.	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.	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

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: 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

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Low carbohydrate diet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Hyperinsulinism; Body Weight Changes; Weight Gain; Insulin Resistance; Gestational Weight Gain
• Other Study ID 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