Nutrition-Lifestyle Therapy for Gestational Diabetes
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current diabetes medications. However, if you are taking non-diabetes medications that affect body weight or metabolism, you may not be eligible to participate.
What data supports the effectiveness of the treatment Nutrition-behavior lifestyle program for gestational diabetes?
Research shows that nutrition therapy is a key part of managing gestational diabetes, and implementing nutrition practice guidelines can lead to better blood sugar control and reduced insulin use. Additionally, lifestyle programs have been effective in improving diet quality in women with previous gestational diabetes.12345
Is Nutrition-Lifestyle Therapy safe for gestational diabetes?
Nutrition therapy is considered a safe and important part of managing gestational diabetes, as supported by several nutrition and diabetes organizations. While specific safety data is limited, the general consensus is that nutrition requirements during pregnancy are similar for women with or without diabetes, indicating a safe approach.12367
How is the Nutrition-behavior lifestyle program treatment different from other treatments for gestational diabetes?
The Nutrition-behavior lifestyle program is unique because it focuses on a community-based approach that combines nutrition and lifestyle changes, rather than relying solely on medical nutrition therapy. This program emphasizes group-based support and education to improve dietary quality and lifestyle habits, which can be more accessible and sustainable for women with gestational diabetes.12389
What is the purpose of this trial?
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.
Research Team
Rachyl Pines, PhD
Principal Investigator
Sansum Diabetes Research Insititute
Eligibility Criteria
This trial is for pregnant Latina women with diabetes, aged 18 or older, who self-identify as Hispanic/Latino and have a BMI between 26.0 and 42.0 kg/m2. It's not for those with Type 1 Diabetes, active substance abuse issues, on certain medications like corticosteroids or antipsychotics, carrying multiple fetuses, if there are fetal malformations present, HbA1c levels ≥10%, or unable to consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention Development
Development of the dietary-lifestyle behavioral intervention through focus groups to incorporate feedback on the program
Treatment
Participants receive the nutrition-behavior lifestyle program with CHWs for 8 sessions (almost weekly from weeks 14 to 27 gestation) and then 4 sessions (almost biweekly from weeks 28-35 gestation)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including glucose monitoring and weight gain assessment
Treatment Details
Interventions
- Nutrition-behavior lifestyle program
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sansum Diabetes Research Institute
Lead Sponsor