An observational study in Weight Stigma, Pregnancy Outcomes and Overweight and Obesity, sponsored by Monash University. Not yet recruiting at 2 sites in Australia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Monash University · Observational
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.
Consenting participants will complete an online survey question at 20-22 weeks' gestation, 29-31 weeks' gestation, 35-37 weeks' gestation, and 6 weeks postpartum. Additional data will be extracted from their EMR.
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? Methods 800 participants will be recruited through the Adelaide Women's and Children's Hospital and Royal Brisbane and Women's Hospital. While waiting for their booking appointment, women will be approached by the researcher or research midwife and asked if they would like to hear about the study. Women who agree will be assessed for eligibility and provided a brief explanation of the research. Eligible women will be given the study information sheet and counselling about their potential participation by the researcher or research midwife. A brief video containing information about study objectives and participation may also be displayed in the waiting areas or available to women to access and watch. Interested women will be invited to scan a QR code to express their interest and provide consent via an online version of the consent form. Consenting participants will complete a online survey question at 20-20 weeks' gestation, 29-31 weeks' gestation, 35-7 weeks' gestation, and 6 weeks postpartum. Additional data will be extracted from their EMR. Information will be collected. The questionnaire will be completed online via the REDCap. Each time, participants will be invited to complete the questionnaire within the next two weeks. At each time point, women who do not complete the questionnaire within the two-week period will be followed up a maximum of three times via email or text message (reminders at 1 week, 11 days, and 14 days post initial survey request).
The survey will collect data on primary and secondary outcomes, as well as independent and potential confounding variables. The primary outcome is gestational diabetes mellitus (GDM). Secondary outcomes include induction of labour, mode of birth, gestational age at birth, infant admission to the neonatal unit, hypertensive disorders of pregnancy (HDP), infant birth weight and length, and infant feeding practices, including the establishment of exclusive breastfeeding.
Independent and potential confounding variables include BMI, experiences and sources of weight stigma, weight loss and weight cycling, medication, supplement, or herbal/homeopathic use, history of trauma, eating disorders or disordered eating, Midwifery Continuity of Care (CoC) model, women's experiences of respectful maternity care, mental health, self-esteem, body image, and labour pain relief measures.
Data will be presented as mean (standard deviation) or median (25th-75th percentile) for continuous variables and as count (percentage) for categorical variables. Comparisons of women's profiles across the outcomes will be performed using Fisher's exact test and t-test and Mann-Whitney tests, as appropriate. For the binary outcomes, univariable and multivariable logistic regression analyses will be conducted to estimate unadjusted and adjusted odds ratios (ORs), respectively. The conceptual models, including the mediation effect of the weight stigma on obesity - adverse outcomes relationships, will be assessed in the structural equation modelling framework
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 800 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Monash University is the lead sponsor of 83 studies on the registry; 22 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Prejudice. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Oct 16, 2026. See what changed
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Proportion of women diagnosed with gestational diabetes mellitus by 35-37 weeks gestation
Measuring the number of women reporting a diagnosis of gestational diabetes mellitus by 35-37 weeks gestation as assessed via self-reported measures and chart review.
Time frame: 35-37 weeks
Proportion of women experiencing induction of labour
Identifying whether the woman's labour was spontaneous or induced measured via a self-reported questionnaire.
Time frame: 6 weeks postpartum
Proportion of women reporting each mode of birth (i.e., vaginal birth, caesarean section, assisted vaginal birth, or other)
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.
Time frame: 6 weeks postpartum
Proportion of women who reported experiencing gestational hypertension in their most recent pregnancy
Identifying the proportion of women who reported a diagnosis of gestational hypertension during their most recent pregnancy via a self-reported questionnaire.
Time frame: 6 weeks postpartum
Infant birth weight (in grams) reported by mothers for their most recent infant
Infant birth weight (in grams) reported by mothers based on their most recent baby's birth certificate or hospital discharge summary information.
Time frame: 6 weeks postpartum
Proportion of women currently breastfeeding their infant reported by mothers at 6-weeks postpartum
The proportion of women currently breastfeeding their infant (yes/no) reported by mothers at 6-weeks postpartum
Time frame: 6 weeks postpartum
Plan to share: Yes — A copy of the raw, fully de-identified prospective survey dataset, along with the corresponding data dictionary and R/Stata analysis scripts, will be uploaded to an open-access repository (such as Monash Bridges / Figshare) upon peer-reviewed publication of primary outcomes. Although primary de-identified survey data will be made available via open-access repositories upon publication, access to the broader, linked longitudinal dataset (including extracted EMR variables and detailed scale sub-scores) is managed under a Managed Access Framework to protect participant confidentiality and ensure responsible secondary data use.
Supporting information: Analytic code
Time frame: After the primary study findings are published and will end based on Monash University's data retention policy
Access criteria: Before submitting a formal application, interested applicants must ensure they meet the baseline eligibility criteria (recognised affiliation, aligning scope) Applicants must submit a completed EMBODY Data Access Request Form to the Lead Investigator (Dr. Briony Hill, Monash University, SPHPM). The application package must include: Project Proposal (Max 2-3 pages); Ethics Clearance; Data Security \& Storage Plan Applications undergo a two-tier review process Upon proposal approval, a formal Data Use Agreement (DUA) must be executed between Monash University and the applicant's host institution. Once the DUA is fully executed, a de-identified, minimal dataset containing only the variables explicitly approved for the project will be shared securely via encrypted, password-protected channels.
Data sharing details ↗ · bridges.monash.edu
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Dec 2027, 10 months later.
Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 10 months is below that.
Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: start Jun 2026 → Feb 2027 and completion Dec 2028 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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