Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06218147
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-12-22
Brief Title:
Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes
Sponsor:
Sansum Diabetes Research Institute
Organization:
Sansum Diabetes Research Institute
Study Overview
Official Title:
Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
Socioeconomically disadvantaged SED pregnant Latina women are disproportionately burdened by type 2 diabetes T2D Although lifestyle interventions can help to improve diabetes control there are barriers to SED Spanish-speaking pregnant people participating The purpose of this proposal is to develop and test a culturally tailored dietary-lifestyle behavioral intervention that supports eating plant-based foods such as fruits vegetables nuts and grains instead of processed foods and meat and is implemented through community health workers CHWs to prevent excessive weight gain during pregnancy and improve control of blood sugar levels in pregnant Latina women with T2D This study takes advantage of our existing strong relationships with the local Latino community CHWs and Santa Barbara County Public Health which includes eight multidisciplinary healthcare clinics with sliding fee programs and Rooted Santa Barbara a community plant-based lifestyle organization Cultural sensitivity focuses on delivering health information based on norms values beliefs environmental factors and historical context that is unique to a racialethnic population Therefore for our program to be culturally sensitive it will include delivery of the program by CHWs primarily in the Spanish language with English as needed and incorporation of culturally relevant eating and physical activity recommendations The specific aims of the project are 1 in year one develop the dietary-lifestyle behavioral intervention that encourages a plant-forward diet for pregnant Latina women with T2D to prevent excessive weight gain during pregnancy and improve blood sugar control in collaboration with CHWs and participants by conducting focus groups to incorporate feedback on the program 2 initiate in year one and in year two conduct a randomized controlled trial with 30 pregnant Latina women with T2D to evaluate the how well the nutrition-behavior lifestyle program works and 3 evaluate the acceptance and delivery of the dietary-lifestyle behavioral intervention in CHWs and participants If successful this study will establish the how well a culturally sensitive program delivered by CHWs incorporating plant-forward diets for pregnant Latina women with T2D prevents excessive weight gain during pregnancy and control of blood sugar levels
Detailed Description:
None
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