Unravelling the Interplay of Weight Stigma and Pregnancy Outcomes: A Prospective Cohort Study

NCT ID: NCT06531694

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-06-30

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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The specific research questions for each objective are:

Objective 1 RQ1.1: Does weight stigma experienced during pregnancy in a healthcare setting reported up to 34 weeks gestation mediate the association between pre-pregnancy obesity (BMI ≥30) and gestational diabetes mellitis (GDM) (primary outcome)?

RQ1.2: Does weight stigma experienced during pregnancy in a healthcare setting reported up to 34 weeks gestation mediate the association between pre-pregnancy obesity (BMI ≥30) and (i) induction of labour; (iv) mode of birth; (ii) gestational hypertension (any); (iii) infant birth weight; and (iv) establishment of breastfeeding by 6 weeks postpartum (secondary outcomes)?

Objective 2:

RQ2.1: Do weight cycling, history of trauma, history of eating disorders, and internalised weight bias explain any of the variance in the mediation relationships described above?

Conditions

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Weight Stigma Pregnancy Outcomes Overweight and Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Pregnant with multiple gestation
* Insufficient English language skills to consent and complete the questionnaires.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Monash University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Briony Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University

Central Contacts

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Briony Hill, PhD

Role: CONTACT

+61421012283

Megan Mitchell, PhD

Role: CONTACT

Other Identifiers

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601966989

Identifier Type: -

Identifier Source: org_study_id

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