Clinical trial NCT06218147: Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes
Official title: Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mel Gestational - in Pregnancy
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent of glucose time in range assessed by using continuous glucose monitor
timeFrame: 30 days at baseline and at 27 weeks gestation, and at 35 weeks gestation.
Secondary outcomes:
measure: Amount of Gestational Weight Gain
timeFrame: assessed at baseline and post-intervention (approximately 27-35 weeks gestation)
measure: Change in Blood Pressure
timeFrame: assessed at baseline and post intervention (approximately 27-35 weeks gestation)
measure: Amount of satisfaction with the Intervention
timeFrame: evaluated immediately post-intervention
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Sansum Diabetes Research Insititute
name: Rachyl Pines, PhD
role: PRINCIPAL_INVESTIGATOR
References: