Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06032143
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-07-26
Brief Title:
Doulas as Environmental Educators and Partners Study
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
Doulas as Environmental Educators and Partners Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEEP
Brief Summary:
The aims of this project are
Aim 1 Determine the extent to which an environmental health literacy educational intervention designed for doulas improves their environmental health literacy of endocrine disrupting chemicals EDCs in personal care products
Hypothesis 1a Doulas who participate in an environmental health literacy course will have a higher environmental health literacy score based on quantitative questionnaire evaluation post-course compared to pre-course
Hypothesis 1b Doulas who participate in the environmental health literacy course will have a higher environmental health literacy scores post-course compared to doulas who do not take the environmental health literacy course
Aim 2 Determine the extent to which pregnant people counseled by doulas with training in environmental health literacy have higher environmental health literacy scores and lower usage of personal care products containing EDCs following doula counseling
Hypothesis 2a Compared to pregnant people not counseled by doulas on EDCs in personal care products pregnant individuals counseled by doulas on these EDCs will have improved scores in environmental health literacy
Hypothesis 2b Compared to pregnant people not counseled by doulas on EDCs in personal care products pregnant individuals receiving counseling will use fewer personal care products associated with containing EDCs based on a validated questionnaire
Aim 3 Determine whether concentrations of EDC biomarkers decreased after the intervention for the intervention group
Hypothesis 3 Urinary phthalate metabolite concentrations will be lower post-course compared to pre-course for the intervention group
Aim 1 Determine the extent to which an environmental health literacy educational intervention designed for doulas improves their environmental health literacy of endocrine disrupting chemicals EDCs in personal care products
Hypothesis 1a Doulas who participate in an environmental health literacy course will have a higher environmental health literacy score based on quantitative questionnaire evaluation post-course compared to pre-course
Hypothesis 1b Doulas who participate in the environmental health literacy course will have a higher environmental health literacy scores post-course compared to doulas who do not take the environmental health literacy course
Aim 2 Determine the extent to which pregnant people counseled by doulas with training in environmental health literacy have higher environmental health literacy scores and lower usage of personal care products containing EDCs following doula counseling
Hypothesis 2a Compared to pregnant people not counseled by doulas on EDCs in personal care products pregnant individuals counseled by doulas on these EDCs will have improved scores in environmental health literacy
Hypothesis 2b Compared to pregnant people not counseled by doulas on EDCs in personal care products pregnant individuals receiving counseling will use fewer personal care products associated with containing EDCs based on a validated questionnaire
Aim 3 Determine whether concentrations of EDC biomarkers decreased after the intervention for the intervention group
Hypothesis 3 Urinary phthalate metabolite concentrations will be lower post-course compared to pre-course for the intervention group
Detailed Description:
Compared to other racialethnic groups non-Hispanic black women have significantly higher concentrations of endocrine disrupting chemicals EDCs found in personal care products including phthalates and parabens These EDCs are linked to a variety of adverse reproductive health outcomes that range from early puberty to preterm birth to hot flashes-all conditions that disproportionately impact black women and their long-term health
Pregnancy is a particularly sensitive window of exposure to EDCs due to normal physiologic changes that alter the bodys lipid and glucose metabolism vasculature inflammatory and coagulation responses Sadly pregnancy holds some of the most shocking racialethnic health disparities including a 50 increased risk of preterm birth up to 2-fold increased risk of preeclampsia and 3-fold increased risk of maternal mortality Gaps in health care access have been documented as important contributors to these adverse health outcomes but little research has evaluated the critical gap in environmental health information particularly information linked to knowledge awareness and action related to EDC exposures In black pregnant people doulas have increasingly served an important role in filling health care gaps by providing access advocacy support and education at this sensitive window Yet doulas often are not equipped to provide key environmental health information around chemical exposures that are higher in black women If doulas environmental health literacy of personal care product EDCs linked to adverse pregnancy outcomes was improved then pregnant people in their care could benefit from reduced exposure to these chemicals and improved pregnancy outcomes With this the investigators intend to leverage the supportive advocacy and educational role doulas provide to black pregnant people to improve EDC environmental health literacy by partnering with Black Millennials 4 Flint organization to 1 educate doulas on EDCs 2 utilize this newly gained knowledge in a clinical setting for doulas to counsel pregnant people on personal care product EDC chemicals 3 measure environmental health literacy in doulas and the pregnant people they counsel 4 evaluate urinary phthalate metabolite concentrations before and after the intervention To conduct this intervention the investigators will leverage a personal care product EDC module developed by the Harvard Chans Environmental Reproductive Justice Lab PI Dr Tamarra James-Todd The investigators will also utilize an environmental health literacy questionnaire as well as other previously validated quantitative and qualitative data collection tools The aims of this project are
Aim 1 Determine the extent to which an environmental health literacy educational intervention designed for doulas improves their environmental health literacy of EDCs in personal care products Hypothesis 1a Doulas who participate in an environmental health literacy course will have a higher environmental health literacy score based on quantitative questionnaire evaluation post-course compared to pre-course Hypothesis 1b Doulas who participate in the environmental health literacy course will have a higher environmental health literacy scores post-course compared to doulas who do not take the environmental health literacy course Aim 2 Determine the extent to which pregnant people counseled by doulas with training in environmental health literacy have higher environmental health literacy scores and lower usage of personal care products containing EDCs following doula counseling Hypothesis 2a Compared to pregnant people not counseled by doulas on EDCs in personal care products pregnant individuals counseled by doulas on these EDCs will have improved scores in environmental health literacy Hypothesis 2b Compared to pregnant people not counseled by doulas on EDCs in personal care products pregnant individuals receiving counseling will use fewer personal care products associated with containing EDCs based on a validated questionnaire Aim 3 Determine whether concentrations of EDC biomarkers decreased after the intervention for the intervention group
Hypothesis 3 Urinary phthalate metabolite concentrations will be lower post-course compared to pre-course for the intervention group
Pregnancy is a particularly sensitive window of exposure to EDCs due to normal physiologic changes that alter the bodys lipid and glucose metabolism vasculature inflammatory and coagulation responses Sadly pregnancy holds some of the most shocking racialethnic health disparities including a 50 increased risk of preterm birth up to 2-fold increased risk of preeclampsia and 3-fold increased risk of maternal mortality Gaps in health care access have been documented as important contributors to these adverse health outcomes but little research has evaluated the critical gap in environmental health information particularly information linked to knowledge awareness and action related to EDC exposures In black pregnant people doulas have increasingly served an important role in filling health care gaps by providing access advocacy support and education at this sensitive window Yet doulas often are not equipped to provide key environmental health information around chemical exposures that are higher in black women If doulas environmental health literacy of personal care product EDCs linked to adverse pregnancy outcomes was improved then pregnant people in their care could benefit from reduced exposure to these chemicals and improved pregnancy outcomes With this the investigators intend to leverage the supportive advocacy and educational role doulas provide to black pregnant people to improve EDC environmental health literacy by partnering with Black Millennials 4 Flint organization to 1 educate doulas on EDCs 2 utilize this newly gained knowledge in a clinical setting for doulas to counsel pregnant people on personal care product EDC chemicals 3 measure environmental health literacy in doulas and the pregnant people they counsel 4 evaluate urinary phthalate metabolite concentrations before and after the intervention To conduct this intervention the investigators will leverage a personal care product EDC module developed by the Harvard Chans Environmental Reproductive Justice Lab PI Dr Tamarra James-Todd The investigators will also utilize an environmental health literacy questionnaire as well as other previously validated quantitative and qualitative data collection tools The aims of this project are
Aim 1 Determine the extent to which an environmental health literacy educational intervention designed for doulas improves their environmental health literacy of EDCs in personal care products Hypothesis 1a Doulas who participate in an environmental health literacy course will have a higher environmental health literacy score based on quantitative questionnaire evaluation post-course compared to pre-course Hypothesis 1b Doulas who participate in the environmental health literacy course will have a higher environmental health literacy scores post-course compared to doulas who do not take the environmental health literacy course Aim 2 Determine the extent to which pregnant people counseled by doulas with training in environmental health literacy have higher environmental health literacy scores and lower usage of personal care products containing EDCs following doula counseling Hypothesis 2a Compared to pregnant people not counseled by doulas on EDCs in personal care products pregnant individuals counseled by doulas on these EDCs will have improved scores in environmental health literacy Hypothesis 2b Compared to pregnant people not counseled by doulas on EDCs in personal care products pregnant individuals receiving counseling will use fewer personal care products associated with containing EDCs based on a validated questionnaire Aim 3 Determine whether concentrations of EDC biomarkers decreased after the intervention for the intervention group
Hypothesis 3 Urinary phthalate metabolite concentrations will be lower post-course compared to pre-course for the intervention group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None