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OpenTrials
Completed

NCT Number: NCT07828743

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

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.

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Key information

Conditions

Obesity & Overweight Body Weight Body Weight Changes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Mellitus in Pregnancy Gestational Weight Gain Glucose Metabolism Disorders Metabolic Diseases Morbid Obesity Nutrition Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Weight Gain

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Multiple gestation
  • pre-gestational diabetes mellitus
  • history of bariatric surgery

Treatment and study plan

Nutrition Education

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Gestational weight gain within guidelines

    Time frame: from first prenatal visit to delivery

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

  2. 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)

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

  3. 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)

    Proportion of patients with 1 hour serum glucose level > 135mg/dL after a 50-gram oral glucose challenge test (OGTT)

  4. Gestational diabetes mellitus

    Time frame: From enrollment to delivery

    Proportion of patients with 1-hour serum glucose level after glucose challenge test (GCT) >200 or failure of 100g oral glucose challenge test (OGTT)

  5. Pregnancy induced hypertension

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

    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.

  6. Postpartum weight at 6 weeks

    Time frame: six weeks postpartum

    Maternal weight

  7. Mode of delivery

    Time frame: at delivery

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

  8. Shoulder dystocia

    Time frame: at delivery

    Proportion of patients with a diagnosis of shoulder dystocia

  9. Birthweight

    Time frame: At delivery

    Weight of neonate at birth

  10. Infant weight at 6 weeks postpartum

    Time frame: 6 weeks postpartum

    neonatal weight

  11. Neonatal length

    Time frame: At delivery

    Length of infant at birth

  12. Neonatal head circumference

    Time frame: At delivery

    Head circumference of neonate at birth

  13. Neonatal abdominal circumference

    Time frame: At delivery

    Circumference around abdomen in a neonate

  14. Infant head circumference

    Time frame: At 6 weeks postpartum

    Head circumference at 6 weeks postpartum

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • UAB Center for Research in Women's Health

Registry information

Acronym: OPTIMAL

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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