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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Postpartum Weight Retention, Insulin Sensitivity

Intervention / Treatment
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* Behavioral: Low carbohydrate diet education
* Behavioral: Low carbohydrate diet education with behavioral component


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Subjects will receive standard counseling on obesity as part of routine postpartum care. | |
| Active Comparator: Low carbohydrate diet education<br>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<br>* A 200 page informational document that connects with an online application will be provided to subjects.<br>|
| Active Comparator: Low carbohydrate diet education with behavioral component<br>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<br>* A 200 page informational document that connects with an online application will be provided to subjects.<br>Behavioral: Low carbohydrate diet education with behavioral component<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low carbohydrate diet