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临床试验/NCT06218147
NCT06218147已完成不适用

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

Sansum Diabetes Research Institute2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Percent of glucose time in range assessed by using continuous glucose monitor

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • Type 1 Diabetes
  • 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
  • Non-singleton fetus
  • Evidence of fetal malformation
  • HbA1c ≥ 10%
  • Unable to provide informed consent or unwilling to complete the study

结局指标

主要结局

Percent of glucose time in range assessed by using continuous glucose monitor

时间窗: 30 days at baseline and at 27 weeks gestation, and at 35 weeks gestation.

All participants will wear a Continuous Glucose Monitor for 30 days at three time points

次要结局

  • Amount of Gestational Weight Gain(assessed at baseline and post-intervention (approximately 27-35 weeks gestation))
  • Change in Blood Pressure(assessed at baseline and post intervention (approximately 27-35 weeks gestation))
  • Amount of satisfaction with the Intervention(evaluated immediately post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachyl Pines

Adjunct Research Scientist

Sansum Diabetes Research Institute

研究点 (2)

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