Insulin Sensitivity, Obesity, Postpartum Weight Retention
Conditions
Keywords
Low carbohydrate diet
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.
Interventions
BEHAVIORALLow carbohydrate diet education
A 200 page informational document that connects with an online application will be provided to subjects.
BEHAVIORALLow 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.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Change in weight measured in pounds. | Baseline, 3 months | The subject will be weighed at baseline and at 3 months.The weight will be calculated in pounds. |
| 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, 3 months | The subject will have blood pressure checked at baseline and at 3 months. Blood pressure will be calculated in mmHg. |
Countries
United States
Outcome results
None listed