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NCT06218147Completed

Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes

Source: ClinicalTrials.gov · Last updated 3 Apr 2025

Brief summary (registry, in English)

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) 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.

Status (registry)
Completed
Study type
Interventional
Enrollment
15 (actual)
First submitted
22 Dec 2023
Start date
1 Apr 2024
Primary completion date
28 Feb 2025
Lead sponsor
Sansum Diabetes Research Institute
NCT number
NCT06218147

What you commit to

  • Study type: Interventional
  • Participants enrolled: 15
  • From 1 Apr 2024 to the primary completion date, 28 Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active substance abuse with alcohol or drugs by self-report
  • Treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect outcome measures

Other illness

  • Type 1 Diabetes

Lab values

  • HbA1c ≥ 10%

Other

  • Non-singleton fetus
  • Evidence of fetal malformation
  • Unable to provide informed consent or unwilling to complete the study

Who the study is looking for

  • Diabetes in pregnancy
  • ≥ 18 years old
  • Self-reported Hispanic and/or Latino/a heritage
  • BMI ≥ 26.0 kg/m2 and ≤ 42.0 kg/m2

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sansum Diabetes Research Institute
Coordinator of this site? Confirm its status
Santa BarbaraUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.