ObesitySLIMNCT04045353
A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth
A study testing Low carbohydrate diet education and Low carbohydrate diet education with behavioral component in people with Obesity and Postpartum Weight Retention, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity, Postpartum Weight Retention, Insulin Sensitivity
- What is being tested?
- Low carbohydrate diet education and Low carbohydrate diet education with behavioral component
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2019to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: A Randomized Trial of a Low Carbohydrate Diet Versus the Current Recommended Dietary Guidelines to Improve Health Outcomes in Obese Postpartum Women
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
- Being tested
- Low carbohydrate diet education, Low carbohydrate diet education with behavioral component
- Keywords
- Low carbohydrate diet
- Medical subject headings
- Obesity, Gestational Weight Gain, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate diet educationBehavioural
A 200 page informational document that connects with an online application will be provided to subjects.
Low carbohydrate diet education with behavioral componentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Low carbohydrate diet education; Behavioral: Low carbohydrate diet education with behavioral component |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 months
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start20 Dec 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Why it stopped: Unable to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara O Jacobs, MD, Principal investigator, University of TexasAntonio Saad, MD, Principal investigator, University of TexasAshley Salazar, WHNP, Study director, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045353
- Sponsor's protocol ID
- 18-0314
- Acronym
- SLIM
- Status last verified
- Apr 2023
- First submitted
- 1 Aug 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22889687Rooney 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.
PubMed 12151145Foster 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.
PubMed 12761365
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Low Carbohydrate Diet Versus the Current Recommended Dietary Guidelines to Improve Health Outcomes in Obese Postpartum Women
- ClinicalTrials.gov ID
- NCT04045353
- Acronym / sponsor ID
- SLIM / 18-0314
- Conditions
- Obesity, Postpartum Weight Retention, Insulin Sensitivity
- Keywords
- Low carbohydrate diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Subjects will receive standard counseling on obesity as part of routine postpartum care. |
| Low carbohydrate diet education | Active comparator | Behavioral: Low carbohydrate diet educationSubjects will receive educational materials regarding a low carbohydrate diet in addition to the standard counseling on obesity as part of routine postpartum care. |
| Low carbohydrate diet education with behavioral component | Active comparator | Behavioral: Low carbohydrate diet education, Behavioral: Low carbohydrate diet education with behavioral componentSubjects 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbohydrate diet educationA 200 page informational document that connects with an online application will be provided to subjects. | Behavioural | Low carbohydrate diet education, Low carbohydrate diet education with behavioral component |
| Low carbohydrate diet education with behavioral componentA 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. | Behavioural | Low carbohydrate diet education with behavioral component |
Primary outcome
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.
Time frame: 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).
6 secondary outcomes
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.
Time frame: Baseline, 6 months
Change in weight measured in pounds.
Time frame: Baseline, 3 months
Change in weight measured in pounds.
Time frame: Baseline, 6 months
Development of diabetes postpartum as measured by 2 hour glucose tolerance test.
Time frame: 3 months
Change in blood pressure as measured by blood pressure cuff in mmHg.
Time frame: Baseline, 3 months
Change in blood pressure as measured by blood pressure cuff in mmHg.
Time frame: Baseline, 6 months
Results and safety
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 22889687Morkrid 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.
- Background: PubMed 12151145Rooney 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.
- Background: PubMed 12761365Foster 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara O Jacobs, MD principal investigator
University of Texas
Antonio Saad, MD principal investigator
University of Texas
Ashley Salazar, WHNP study director
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate diet education and Low carbohydrate diet education with behavioral component in people with Obesity and Postpartum Weight Retention, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity. (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04045353, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.