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

Not Applicable

Terminated

• Conditions: Insulin Sensitivity; Postpartum Weight Retention; Obesity
• Interventions: Behavioral: Low carbohydrate diet education; Behavioral: Low carbohydrate diet education with behavioral component

• Registration Number: NCT04045353
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Study Start: 2019-12-20
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low carbohydrate diet education with behavioral component	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 with behavioral component	Low carbohydrate diet education	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	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.

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.	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).

Secondary Outcome Measures

Name	Time	Method
Change in weight measured in pounds.	Baseline, 6 months	The subject will be weighed at baseline and at 6 months. The weight will be calculated in pounds.
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.	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).
Development of diabetes postpartum as measured by 2 hour glucose tolerance test.	3 months	As part of routine postpartum care, women at risk for diabetes have a glucose tolerance test performed within 3 months postpartum.
Change in blood pressure as measured by blood pressure cuff in mmHg.	Baseline, 6 months	The subject will have blood pressure checked at baseline and at 6 months. Blood pressure will be calculated in mmHg.

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States