Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531694
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
Unravelling the Interplay of Weight Stigma and Pregnancy Outcomes A Prospective Cohort Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Unravelling the Interplay of Weight Stigma and Pregnancy Outcomes A Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 kgm2 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
Objective 1 Explore weight stigma as a mediator of the association between BMI 30 kgm2 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 RQ11 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
RQ12 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
RQ21 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
Objective 1 RQ11 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
RQ12 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
RQ21 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None