Obesity & OverweightOPTIMALNCT07828743
Evaluation of Nutritional Interventions to Limit Gestational Weight Gain in Women With Class III Obesity (BMI >40)
A study testing Nutrition education in people with Obesity & Overweight and Gestational Diabetes Mellitus in Pregnancy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Women with obesity who gain more weight than recommended during pregnancy are more likely to have problems such as cesarean delivery, diabetes in pregnancy, high blood pressure, and larger babies. Standard prenatal care does not usually include nutrition counseling based on weight alone. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obesity & Overweight, Gestational Diabetes Mellitus in Pregnancy, Gestational Weight Gain
- What is being tested?
- Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 6 Jan 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prenatal care <12 weeks gestation at University of Alabama at Birmingham
- Body mass index ≥ 30 at first prenatal visit;
Who cannot join
- Multiple gestation
- pre-gestational diabetes mellitus
- history of bariatric surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Women with obesity who gain more weight than recommended during pregnancy are more likely to have problems such as cesarean delivery, diabetes in pregnancy, high blood pressure, and larger babies. Standard prenatal care does not usually include nutrition counseling based on weight alone. This trial tested whether adding group nutrition classes during pregnancy helps these women gain less weight during pregnancy compared to standard prenatal care alone.
- Conditions
- Obesity & Overweight, Gestational Diabetes Mellitus in Pregnancy, Gestational Weight Gain, Morbid Obesity, Nutrition Behavior
- Being tested
- Nutrition education
- Keywords
- obesity, gestational diabetes, gestational weight gain, nutrition, intervention
- Medical subject headings
- Obesity, Overweight, Gestational Weight Gain, Obesity, Morbid, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educationBehavioural
The intervention arm will include nutritional education, including healthy dietary practices and recipe prep with cooking demonstrations.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants received standard prenatal care at UAB, which does not include nutrition counseling based on obesity alone. |
| Usual Care plus Nutrition Education | Experimental | Nutrition education included 1) review of recommendations for GWG and physical activity, 2) review of a unique nutrition topic, 3) a recorded cooking demonstration, and 4) receipt of ingredients for the recorded recipe. Receives: Behavioral: Nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Weight difference from first prenatal visit to weight recorded at delivery, analyzed as a continuous outcome
Measured: From first prenatal visit to delivery
Secondary outcomes (14)
Gestational weight gain within guidelines
Proportion of patients with gestational weight gain between 11-20 pounds from enrollment to delivery
Measured: from first prenatal visit to delivery
1-hour serum glucose after 50 gram oral glucose challenge test
1 hour serum glucose level after 50g oral glucose challenge test (OGTT)
Measured: 24-28 weeks gestational age (but can occur greater than 20 weeks gestational age to delivery)
Abnormal 1-hour serum glucose after 50 gram oral glucose challenge test
Proportion of patients with 1 hour serum glucose level > 135mg/dL after a 50-gram oral glucose challenge test (OGTT)
Measured: 24-28 weeks gestational age (but can occur greater than 20 weeks gestational age to delivery)
Gestational diabetes mellitus
Proportion of patients with 1-hour serum glucose level after glucose challenge test (GCT) >200 or failure of 100g oral glucose challenge test (OGTT)
Measured: From enrollment to delivery
Pregnancy induced hypertension
Proportion of patients with any of gestational hypertension, pre-eclampsia, severe pre-eclampsia, Hemolysis, Elevated Liver enzymes, and Low Platelet count (HELLP), eclampsia and pregnancy induced hypertension (PIH) unspecified.
Measured: From 20 weeks gestational age to 6 weeks postpartum
Postpartum weight at 6 weeks
Maternal weight
Measured: six weeks postpartum
Mode of delivery
Proportion of patients with spontaneous vaginal delivery, operative vaginal delivery, or cesarean
Measured: at delivery
Shoulder dystocia
Proportion of patients with a diagnosis of shoulder dystocia
Measured: at delivery
Birthweight
Weight of neonate at birth
Measured: At delivery
Infant weight at 6 weeks postpartum
neonatal weight
Measured: 6 weeks postpartum
Neonatal length
Length of infant at birth
Measured: At delivery
Neonatal head circumference
Head circumference of neonate at birth
Measured: At delivery
Neonatal abdominal circumference
Circumference around abdomen in a neonate
Measured: At delivery
Infant head circumference
Head circumference at 6 weeks postpartum
Measured: At 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start12 Oct 2023
- Primary completion18 Dec 2025
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- UAB Center for Research in Women's Health
- Responsible party
- Principal investigator, Akila Subramaniam, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828743
- Sponsor's protocol ID
- IRB-300004211
- Other IDs
- CRWH Pilot Grant
- Acronym
- OPTIMAL
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutritional Interventions to Limit Gestational Weight Gain in Women With Class III Obesity (BMI >40)
- ClinicalTrials.gov ID
- NCT07828743
- Acronym / sponsor ID
- OPTIMAL / IRB-300004211
- Conditions
- Obesity & Overweight, Gestational Diabetes Mellitus in Pregnancy, Gestational Weight Gain, Morbid Obesity, Nutrition Behavior
- Keywords
- obesity, gestational diabetes, gestational weight gain, nutrition, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- UAB Center for Research in Women's Health
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 18 Sep 2026 (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.
Women with obesity who gain more weight than recommended during pregnancy are more likely to have problems such as cesarean delivery, diabetes in pregnancy, high blood pressure, and larger babies. Standard prenatal care does not usually include nutrition counseling based on weight alone. This trial tested whether adding group nutrition classes during pregnancy helps these women gain less weight during pregnancy compared to standard prenatal care alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants received standard prenatal care at UAB, which does not include nutrition counseling based on obesity alone. |
| Usual Care plus Nutrition Education | Experimental | Behavioral: Nutrition educationNutrition education included 1) review of recommendations for GWG and physical activity, 2) review of a unique nutrition topic, 3) a recorded cooking demonstration, and 4) receipt of ingredients for the recorded recipe. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Prenatal care <12 weeks gestation at University of Alabama at Birmingham
- Body mass index ≥ 30 at first prenatal visit;
Key exclusion criteria (3 listed)
- Multiple gestation
- pre-gestational diabetes mellitus
- history of bariatric surgery
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 |
|---|---|---|
| Nutrition educationThe intervention arm will include nutritional education, including healthy dietary practices and recipe prep with cooking demonstrations. | Behavioural | Usual Care plus Nutrition Education |
Primary outcome
Gestational weight gain
Time frame: From first prenatal visit to delivery
Weight difference from first prenatal visit to weight recorded at delivery, analyzed as a continuous outcome
14 secondary outcomes
Gestational weight gain within guidelines
Time frame: from first prenatal visit to delivery
1-hour serum glucose after 50 gram oral glucose challenge test
Time frame: 24-28 weeks gestational age (but can occur greater than 20 weeks gestational age to delivery)
Abnormal 1-hour serum glucose after 50 gram oral glucose challenge test
Time frame: 24-28 weeks gestational age (but can occur greater than 20 weeks gestational age to delivery)
Gestational diabetes mellitus
Time frame: From enrollment to delivery
Pregnancy induced hypertension
Time frame: From 20 weeks gestational age to 6 weeks postpartum
Postpartum weight at 6 weeks
Time frame: six weeks postpartum
Mode of delivery
Time frame: at delivery
Shoulder dystocia
Time frame: at delivery
Birthweight
Time frame: At delivery
Infant weight at 6 weeks postpartum
Time frame: 6 weeks postpartum
Neonatal length
Time frame: At delivery
Neonatal head circumference
Time frame: At delivery
Neonatal abdominal circumference
Time frame: At delivery
Infant head circumference
Time frame: At 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education in people with Obesity & Overweight and Gestational Diabetes Mellitus in Pregnancy, run by University of Alabama at Birmingham 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Sep 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gestational weight gain (time frame: From first prenatal visit to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.