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

NCT04045353 | Terminated

• 1 other identifier: 18-0314
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Postpartum Weight Retention; Insulin Sensitivity

Keywords

Low carbohydrate diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.

  Baseline, 6 months

• Change in weight measured in pounds.

  Baseline, 3 months

• Change in weight measured in pounds.

  Baseline, 6 months

• Development of diabetes postpartum as measured by 2 hour glucose tolerance test.

  3 months

• Change in blood pressure as measured by blood pressure cuff in mmHg.

  Baseline, 3 months

Study Arms (3)

Standard of care

NO INTERVENTION

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

Low carbohydrate diet education

ACTIVE COMPARATOR

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

Low carbohydrate diet education with behavioral component

ACTIVE COMPARATOR

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; Behavioral: Low carbohydrate diet education with behavioral component

Interventions

Low carbohydrate diet education BEHAVIORAL

A 200 page informational document that connects with an online application will be provided to subjects.

Low carbohydrate diet education; Low carbohydrate diet education with behavioral component

Low carbohydrate diet education with behavioral component BEHAVIORAL

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.

Low carbohydrate diet education with behavioral component

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: This study is limited subjects that are postpartum; therefore, can only include female participants.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (3)

• 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.

  PMID: 22889687 BACKGROUND

• 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.

  PMID: 12151145 BACKGROUND

• 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.

  PMID: 12761365 BACKGROUND

MeSH Terms

Conditions

Obesity; Gestational Weight Gain; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Sara O Jacobs, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Antonio Saad, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Ashley Salazar, WHNP

  University of Texas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: December 20, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)