Weight StigmaEMBODYNCT06531694
EMBodied psychOsocial Impacts of Weight Stigma During Pregnancy (EMBODY): A Prospective Cohort Study
An observational study of Weight Stigma and Pregnancy Outcomes, run by Monash University at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Weight Stigma, Pregnancy Outcomes, Overweight and Obesity
- How many people
- 800 participants
- Where
- 2 sitesAustralia
- Study dates
- Feb 2027to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- Can complete consent and study procedures in English
Who cannot join
- Pregnant with multiple gestation
- Insufficient English language skills to consent and complete the questionnaires.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Megan Mitchell, PhD contact
Australia2 sites
The Women's and Children's Hospital
Adelaide, South Australia
Megan Mitchell, PhD, 08 8161 8427, megan.mitchell@adelaide.edu.au
The Royal Brisbane and Women's Hospital
Brisbane, Queensland
Leonie Callaway, PhD, 3646 8785, Leonie.Callaway@health.qld.gov.au
About this study
Official title: EMBodied PsychOsocial Impacts of Weight Stigma During Pregnancy (EMBODY): 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.
Read more
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.
Read the 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? 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
- Conditions
- Weight Stigma, Pregnancy Outcomes, Overweight and Obesity
- Keywords
- Prenatal care, Healthcare, maternity care
- Medical subject headings
- Weight Prejudice, Overweight, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 35-37 weeks
Secondary outcomes (5)
Proportion of women experiencing induction of labour
Identifying whether the woman's labour was spontaneous or induced measured via a self-reported questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study startFeb 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight StigmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Women's and Children's Hospital, Australia, Royal Brisbane and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Briony Hill, PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531694
- Sponsor's protocol ID
- 601966989
- Acronym
- EMBODY
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMBodied PsychOsocial Impacts of Weight Stigma During Pregnancy (EMBODY): A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06531694
- Acronym / sponsor ID
- EMBODY / 601966989
- Conditions
- Weight Stigma, Pregnancy Outcomes, Overweight and Obesity
- Keywords
- Prenatal care, Healthcare, maternity care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Women's and Children's Hospital, Australia, Royal Brisbane and Women's Hospital
- Study start
- Feb 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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? 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant with multiple gestation
- Insufficient English language skills to consent and complete the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of women diagnosed with gestational diabetes mellitus by 35-37 weeks gestation
Time frame: 35-37 weeks
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Mitchell, PhD contact
Briony Hill, PhD principal investigator
Monash University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Stigma and Pregnancy Outcomes, run by Monash University at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Briony Hill, PhD (+61421012283, briony.hill@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women diagnosed with gestational diabetes mellitus by 35-37 weeks gestation (time frame: 35-37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.