NCT07828743

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

2.2 years

First QC Date

September 9, 2026

Last Update Submit

September 15, 2026

Conditions

Obesity & OverweightGestational Diabetes Mellitus in PregnancyMorbid ObesityGestational Weight GainNutrition Behavior

Keywords

obesitygestational diabetesgestational weight gainnutritionintervention

Outcome Measures

Primary Outcomes (1)

  • Gestational weight gain

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

    From first prenatal visit to delivery

Secondary Outcomes (14)

  • Gestational weight gain within guidelines

    from first prenatal visit to delivery

  • 1-hour serum glucose after 50 gram oral glucose challenge test

    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

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

  • Gestational diabetes mellitus

    From enrollment to delivery

  • Pregnancy induced hypertension

    From 20 weeks gestational age to 6 weeks postpartum

  • +9 more secondary outcomes

Study Arms (2)

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.

Behavioral: Nutrition education

Interventions

Nutrition educationBEHAVIORAL

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

Usual Care plus Nutrition Education

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiologic women as they can be pregnant
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

ObesityOverweightGestational Weight GainObesity, MorbidDiabetes, Gestational

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWeight GainBody Weight ChangesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 18, 2026

Study Start

October 12, 2023

Primary Completion

December 18, 2025

Study Completion

January 6, 2026

Last Updated

September 18, 2026

Record last verified: 2026-09

Locations

US(1)