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

Obesity Clinical Trial

— SLIM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04045353
• Other study ID #: 18-0314
• Status: Terminated
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: April 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gestational Weight Gain
• Insulin Resistance
• Insulin Sensitivity
• Obesity
• Postpartum Weight Retention

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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