Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT06531694
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?
Study:
NCT06531694
Study Brief:
Protocol Section:
NCT06531694