Clinical trial NCT06531694: Unravelling the Interplay of Weight Stigma and Pregnancy Outcomes: A Prospective Cohort Study
Official title: Unravelling the Interplay of Weight Stigma and Pregnancy Outcomes: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Weight Stigma
Pregnancy Outcomes
Overweight and Obesity
Keywords: Prenatal care
Healthcare
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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?

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.

Primary outcomes:
measure: Proportion of women diagnosed with gestational diabetes mellitis by 34 weeks gestation
timeFrame: 34 weeks
Secondary outcomes:
measure: Proportion of women experiencing induction of labour
timeFrame: 6 weeks postpartum
measure: Proportion of women reporting each mode of birth (i.e., vaginal birth, caesarean section, assisted vaginal birth, or other)
timeFrame: 6 weeks postpartum
measure: Proportion of women who reported experiencing gestational hypertension in their most recent pregnancy
timeFrame: 6 weeks postpartum
measure: Infant birth weight (in grams) reported by mothers for their most recent infant
timeFrame: 6 weeks postpartum
measure: Proportion of women currently breastfeeding their infant reported by mothers at 6-weeks postpartum
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
Study officials:
affiliation: Monash University
name: Briony Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References: