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NCT Number: NCT06531694

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

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.

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Key information

Conditions

Weight Stigma Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Pregnancy Outcomes Prejudice Signs and Symptoms Social Behavior Weight Prejudice

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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?

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 34 weeks

    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.

Secondary outcomes

  1. Proportion of women experiencing induction of labour

    Time frame: 6 weeks postpartum

    Identifying whether the woman's labour was spontaneous or induced measured via a self-reported questionnaire.

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

    Time frame: 6 weeks postpartum

    Identifying the mode of birth assessed via a self-reported questionnaire. Options are: vaginal birth, caesarean section, assisted vaginal birth (e.g., with forceps), or other.

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

    Time frame: 6 weeks postpartum

    Identifying the proportion of women who reported a diagnosis of gestational hypertension during their most recent pregnancy via a self-reported questionnaire.

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

    Time frame: 6 weeks postpartum

    Infant birth weight (in grams) reported by mothers based on their most recent baby's birth certificate or hospital discharge summary information.

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

    Time frame: 6 weeks postpartum

    The proportion of women currently breastfeeding their infant (yes/no) reported by mothers at 6-weeks postpartum

Study contacts

Contact information is provided by the study sponsor or research team.

Briony Hill, PhD

CONTACT

[email protected]

+61421012283

Megan Mitchell, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Monash University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Feb 4, 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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