NCT06531694

Brief Summary

The goal of this prospective cohort study is to investigate the contribution of stigma and discrimination due to body size to adverse pregnancy outcomes. We also aim to explore the role of psychological and social factors in this relationship. The specific objectives of this study are: Objective 1: Explore weight stigma as a mediator of the association between BMI ≥30 kg/m2 and adverse pregnancy outcomes. Objective 2: Explore confounding factors not previously considered such as weight cycling, trauma, eating disorders, and internalised weight bias as mediators in the relationship between obesity and adverse pregnancy outcomes.

Trial Health

65
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Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Jun 2026

Typical duration for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 7, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

July 7, 2024

Last Update Submit

February 1, 2026

Conditions

Keywords

Prenatal careHealthcare

Outcome Measures

Primary Outcomes (1)

  • Proportion of women diagnosed with gestational diabetes mellitis by 34 weeks gestation

    Measuring the number of women reporting a diagnosis of gestational diabetes mellitis by 34 weeks gestation as assessed via self-reported measures and chart review.

    34 weeks

Secondary Outcomes (5)

  • Proportion of women experiencing induction of labour

    6 weeks postpartum

  • Proportion of women reporting each mode of birth (i.e., vaginal birth, caesarean section, assisted vaginal birth, or other)

    6 weeks postpartum

  • Proportion of women who reported experiencing gestational hypertension in their most recent pregnancy

    6 weeks postpartum

  • Infant birth weight (in grams) reported by mothers for their most recent infant

    6 weeks postpartum

  • Proportion of women currently breastfeeding their infant reported by mothers at 6-weeks postpartum

    6 weeks postpartum

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who are pregnant between 10-22 weeks gestation
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be pregnant women who are at least 18 years old with a singleton pregnancy, and who are booked in to give birth at Adelaide Women's and Children's Hospital or Royal Women's and Children's Brisbane. At baseline, women must be between 10 and 22 weeks' gestation.

You may qualify if:

  • Pregnant between 10-22 weeks' gestation
  • Greater or equal than 18 years of age
  • Booked to give birth at Adelaide Women's and Children's Hospital or Royal Women's and Children's Brisbane
  • Access to the Internet to complete the survey
  • Consents to the extraction of hospital electronic medical record data about the woman and relevant to the study.
  • Ability to read and understand English

You may not qualify if:

  • Pregnant with multiple gestation
  • Insufficient English language skills to consent and complete the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight PrejudiceOverweightObesity

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Briony Hill, PhD

    Monash University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Briony Hill, PhD

CONTACT

Megan Mitchell, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2024

First Posted

August 1, 2024

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

February 4, 2026

Record last verified: 2026-02