ClinicalTrials.gg
CompletedNCT07828743OPTIMALUpdated Sep 18, 2026

Evaluation of Nutritional Interventions to Limit Gestational Weight Gain in Women With Class III Obesity (BMI >40)

An interventional study of Nutrition education in Obesity & Overweight, Gestational Diabetes Mellitus in Pregnancy and Gestational Weight Gain, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2026-09-18.

Primary conditionObesity, MorbidRegistry: ObesityReclassifiedWhy we changed it
Registry
Obesity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity, Morbid
Why
  1. The study's listed conditions name Obesity, Morbid, a narrower term within Obesity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Oct 2023, registered Sep 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Sex
Female
01

Study 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. This trial tested whether adding group nutrition classes during pregnancy helps these women gain less weight during pregnancy compared to standard prenatal care alone.

02

Conditions studied

  • Obesity & Overweight
  • Gestational Diabetes Mellitus in Pregnancy
  • Gestational Weight Gain
  • Morbid Obesity
  • Nutrition Behavior

Keywords

  • obesity
  • gestational diabetes
  • gestational weight gain
  • nutrition
  • intervention
03

In context

Obesity, Morbid Reclassified

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

This study's enrollment of 108 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Compared within Obesity, Morbid, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obesity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Prenatal care \<12 weeks gestation at University of Alabama at Birmingham
  • ≥ 30 at first prenatal visit;

Exclusion criteria

Exclusion Criteria:

  • Multiple gestation
  • pre-gestational diabetes mellitus
  • history of bariatric surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • No intervention
    Usual care

    Participants received standard prenatal care at UAB, which does not include nutrition counseling based on obesity alone.

  • Experimental
    Usual Care plus Nutrition Education

    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.

    Behavioral: Nutrition education

Interventions

  • BehavioralNutrition education

    The intervention arm will include nutritional education, including healthy dietary practices and recipe prep with cooking demonstrations.

06

What researchers measure

Primary outcomes

  1. Gestational weight gain

    Weight difference from first prenatal visit to weight recorded at delivery, analyzed as a continuous outcome

    Time frame: From first prenatal visit to delivery

Secondary outcomes

  1. Gestational weight gain within guidelines

    Proportion of patients with gestational weight gain between 11-20 pounds from enrollment to delivery

    Time frame: from first prenatal visit to delivery

  2. 1-hour serum glucose after 50 gram oral glucose challenge test

    1 hour serum glucose level after 50g oral glucose challenge test (OGTT)

    Time frame: 24-28 weeks gestational age (but can occur greater than 20 weeks gestational age to delivery)

  3. 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)

    Time frame: 24-28 weeks gestational age (but can occur greater than 20 weeks gestational age to delivery)

  4. 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)

    Time frame: From enrollment to delivery

  5. 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.

    Time frame: From 20 weeks gestational age to 6 weeks postpartum

  6. Postpartum weight at 6 weeks

    Maternal weight

    Time frame: six weeks postpartum

  7. Mode of delivery

    Proportion of patients with spontaneous vaginal delivery, operative vaginal delivery, or cesarean

    Time frame: at delivery

  8. Shoulder dystocia

    Proportion of patients with a diagnosis of shoulder dystocia

    Time frame: at delivery

  9. Birthweight

    Weight of neonate at birth

    Time frame: At delivery

  10. Infant weight at 6 weeks postpartum

    neonatal weight

    Time frame: 6 weeks postpartum

  11. Neonatal length

    Length of infant at birth

    Time frame: At delivery

  12. Neonatal head circumference

    Head circumference of neonate at birth

    Time frame: At delivery

  13. Neonatal abdominal circumference

    Circumference around abdomen in a neonate

    Time frame: At delivery

  14. Infant head circumference

    Head circumference at 6 weeks postpartum

    Time frame: At 6 weeks postpartum

07

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35249, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07828743
Collaborators
UAB Center for Research in Women's Health
Responsible party
Akila Subramaniam (Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Sep 18, 2026
Start date
Oct 12, 2023
Primary completion
Dec 18, 2025
Completion
Jan 6, 2026
Last update
Sep 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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