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Not yet recruiting NCT06531694

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

Observational Weight Stigma Pregnancy Outcomes Overweight and Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Weight Stigma, Pregnancy Outcomes, Overweight and Obesity. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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?

Primary outcome measures

  • Proportion of women diagnosed with gestational diabetes mellitis by 34 weeks gestation [Time frame: 34 weeks]
Secondary outcome measures (5)
  • Proportion of women experiencing induction of labour [Time frame: 6 weeks postpartum]
  • Proportion of women reporting each mode of birth (i.e., vaginal birth, caesarean section, assisted vaginal birth, or other) [Time frame: 6 weeks postpartum]
  • Proportion of women who reported experiencing gestational hypertension in their most recent pregnancy [Time frame: 6 weeks postpartum]
  • Infant birth weight (in grams) reported by mothers for their most recent infant [Time frame: 6 weeks postpartum]
  • Proportion of women currently breastfeeding their infant reported by mothers at 6-weeks postpartum [Time frame: 6 weeks postpartum]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06531694 · 601966989

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗