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

NCT06218147 | Completed DMC

• 1 other identifier: SCON-00003510
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mel Gestational - in Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Standard care group

NO INTERVENTION

Participants in this group will meet with their CHW for 8 sessions (almost weekly from weeks 14 to 27 gestation) and then 4 sessions (almost biweekly from weeks 28-35 gestation) to match the contact provided in dietary-lifestyle behavioral intervention group. Sessions will be held in person, with videoconferencing and phone call options available when in person is not possible. In these brief check-in sessions, the CHW will be focused on maintaining regular contact, connecting participants to community resources, checking in about any new or ongoing medical issues described by participant during each session visit, and providing overall general information about diabetes management when indicated. CGM will be blinded for both groups.

Nutrition-behavior lifestyle program group

EXPERIMENTAL

Participants in this group meet with their CHWs for 8 sessions (almost weekly from weeks 14 to 27 gestation) and then 4 sessions (almost biweekly from weeks 28-35 gestation). Sessions are held in person, with videoconferencing and phone call options available when in person is not possible. CGM wear is blinded in both groups. The topics for each session are: 1. Welcome and Understanding Diabetes in Pregnancy 2. Understanding Food Groups \& Setting Goals 3. Understanding Carbohydrate Types \& Portions 4. Reading Nutrition Labels \& Understanding Added Sugar 5. Exercise in Pregnancy \& Carbohydrate Counting 6. Grocery Shopping \& Using SNAP or WIC Benefits 7. Managing Stress - Communal Coping as a Family 8. Getting Ready for Baby \& My Family Plan 9. How to Receive Social Support 10. Making Choices at Restaurants \& Social Eating Settings 11. Learning Empowered Communication with Providers 12. Maintaining Changes \& Staying Motivated

Behavioral: Nutrition-behavior lifestyle program

Interventions

Nutrition-behavior lifestyle program BEHAVIORAL

The 15 participants randomized to the intervention group will complete the activities described in the arm/group description.

Also known as: Plant forward dietary lifestyle intervention

Nutrition-behavior lifestyle program group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rachyl Pines, PhD

  Sansum Diabetes Research Insititute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Research Scientist

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 23, 2024
• Study Start: April 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 27, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)