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NCT06218147 · ClinicalTrials.gov registry record · NA
Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes
A NA study, sponsored by Sansum Diabetes Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT06218147 is a NA study that has completed, run by Sansum Diabetes Research Institute. The registered enrollment target is 15 participants.
The verdict
NCT06218147, a NA study, has completed, sponsored by Sansum Diabetes Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study 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 racial/ethnic 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) evalu
Interventions
- BEHAVIORAL Nutrition-behavior lifestyle program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2025-03-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06218147
The ClinicalTrials.gov registry entry for NCT06218147 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sansum Diabetes Research Institute, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nutrition-behavior lifestyle program is the first listed.
NCT06218147 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06218147 about?
NCT06218147 is a clinical study titled "Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes". 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 d...
What is the current status of trial NCT06218147?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2024-04-01. Estimated completion is 2025-03-27.
What interventions are being tested in trial NCT06218147?
The interventions under investigation include: Nutrition-behavior lifestyle program (BEHAVIORAL).
Who is sponsoring clinical trial NCT06218147?
This trial is sponsored by Sansum Diabetes Research Institute, which has 33 total clinical trials registered on ClinicalTrials.gov.
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