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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218147
• Other study ID #: SCON-00003510
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sansum Diabetes Research Institute
• Contact: Brandon Cobb, BA
• Phone: 8056827640
• Email: bcobb[@]sansum.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Nutrition-behavior lifestyle program
The 15 participants randomized to the intervention group will complete the activities described in the arm/group description.

Locations

Country	Name	City	State
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Sansum Diabetes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of glucose time in range assessed by using continuous glucose monitor	All participants will wear a Continuous Glucose Monitor for 30 days at three time points	30 days at baseline and at 27 weeks gestation, and at 35 weeks gestation.
Secondary	Amount of Gestational Weight Gain	weight gain in kilograms by measurements on a scale during study visits	assessed at baseline and post-intervention (approximately 27-35 weeks gestation)
Secondary	Change in Blood Pressure	systolic and diastolic blood pressure	assessed at baseline and post intervention (approximately 27-35 weeks gestation)
Secondary	Amount of satisfaction with the Intervention	self-reported satisfaction satisfaction with the intervention assessed by surveys created for the purposes of this study	evaluated immediately post-intervention