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

S

Sansum Diabetes Research Institute

Status

Enrolling

Conditions

Diabetes Mel Gestational - in Pregnancy
Diabetes Mellitus, Type 2

Treatments

Behavioral: Nutrition-behavior lifestyle program

Study type

Interventional

Funder types

Other

Identifiers

NCT06218147
SCON-00003510

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Standard care group
No Intervention group
Description:
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 group
Description:
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: Welcome and Understanding Diabetes in Pregnancy Understanding Food Groups & Setting Goals Understanding Carbohydrate Types & Portions Reading Nutrition Labels & Understanding Added Sugar Exercise in Pregnancy & Carbohydrate Counting Grocery Shopping & Using SNAP or WIC Benefits Managing Stress - Communal Coping as a Family Getting Ready for Baby & My Family Plan How to Receive Social Support Making Choices at Restaurants & Social Eating Settings Learning Empowered Communication with Providers Maintaining Changes & Staying Motivated
Treatment:
Behavioral: Nutrition-behavior lifestyle program

Trial contacts and locations

1

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Central trial contact

Brandon Cobb, BA

Data sourced from clinicaltrials.gov

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