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

The University of Texas System (UT)

Status: Terminated

Conditions: Postpartum Weight Retention; Obesity; Insulin Sensitivity

Treatments: Behavioral: Low carbohydrate diet education; Behavioral: Low carbohydrate diet education with behavioral component

Study type: Interventional

Funder types: Other

Identifiers

NCT04045353

18-0314

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 3 patient groups

Standard of care

No Intervention group

Description:

Subjects will receive standard counseling on obesity as part of routine postpartum care.

Low carbohydrate diet education

Active Comparator group

Description:

Subjects will receive educational materials regarding a low carbohydrate diet in addition to the standard counseling on obesity as part of routine postpartum care.

Treatment:

Behavioral: Low carbohydrate diet education

Low carbohydrate diet education with behavioral component

Active Comparator group

Description:

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.

Treatment:

Behavioral: Low carbohydrate diet education with behavioral component

Behavioral: Low carbohydrate diet education