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

Primary Purpose

Obesity, Postpartum Weight Retention, Insulin Sensitivity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low carbohydrate diet education
Low carbohydrate diet education with behavioral component
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Low carbohydrate diet

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Standard of care

Low carbohydrate diet education

Low carbohydrate diet education with behavioral component

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Change in weight measured in pounds.
The subject will be weighed at baseline and at 3 months.The weight will be calculated in pounds.
Change in weight measured in pounds.
The subject will be weighed at baseline and at 6 months. The weight will be calculated in pounds.
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.
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.
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.

Full Information

First Posted
August 1, 2019
Last Updated
April 14, 2023
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT04045353
Brief Title
A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth
Acronym
SLIM
Official Title
A Randomized Trial of a Low Carbohydrate Diet Versus the Current Recommended Dietary Guidelines to Improve Health Outcomes in Obese Postpartum Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit subjects
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Postpartum Weight Retention, Insulin Sensitivity
Keywords
Low carbohydrate diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Subjects will receive standard counseling on obesity as part of routine postpartum care.
Arm Title
Low carbohydrate diet education
Arm Type
Active Comparator
Arm 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.
Arm Title
Low carbohydrate diet education with behavioral component
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Low carbohydrate diet education
Intervention Description
A 200 page informational document that connects with an online application will be provided to subjects.
Intervention Type
Behavioral
Intervention Name(s)
Low carbohydrate diet education with behavioral component
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.
Description
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).
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.
Description
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).
Time Frame
Baseline, 6 months
Title
Change in weight measured in pounds.
Description
The subject will be weighed at baseline and at 3 months.The weight will be calculated in pounds.
Time Frame
Baseline, 3 months
Title
Change in weight measured in pounds.
Description
The subject will be weighed at baseline and at 6 months. The weight will be calculated in pounds.
Time Frame
Baseline, 6 months
Title
Development of diabetes postpartum as measured by 2 hour glucose tolerance test.
Description
As part of routine postpartum care, women at risk for diabetes have a glucose tolerance test performed within 3 months postpartum.
Time Frame
3 months
Title
Change in blood pressure as measured by blood pressure cuff in mmHg.
Description
The subject will have blood pressure checked at baseline and at 3 months. Blood pressure will be calculated in mmHg.
Time Frame
Baseline, 3 months
Title
Change in blood pressure as measured by blood pressure cuff in mmHg.
Description
The subject will have blood pressure checked at baseline and at 6 months. Blood pressure will be calculated in mmHg.
Time Frame
Baseline, 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is limited subjects that are postpartum; therefore, can only include female participants.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara O Jacobs, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Saad, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashley Salazar, WHNP
Organizational Affiliation
University of Texas
Official's Role
Study Director
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22889687
Citation
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.
Results Reference
background
PubMed Identifier
12151145
Citation
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.
Results Reference
background
PubMed Identifier
12761365
Citation
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.
Results Reference
background

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

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