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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: Completed NA study, sponsored by Sansum Diabetes Research Institute.
NCT06218147 is a NA study that has completed, run by Sansum Diabetes Research Institute. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
All participants will wear a Continuous Glucose Monitor for 30 days at three time points
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 |
What the finished NCT06218147 record still lists
NCT06218147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Nutrition-behavior lifestyle program is the first listed.
NCT06218147 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06218147's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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