15 Participants Needed

Nutrition-Lifestyle Therapy for Gestational Diabetes

BC
Overseen ByBrandon Cobb, BA
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Sansum Diabetes Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

RP

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

I had diabetes during my pregnancy.
Self-reported Hispanic and/or Latino/a heritage
BMI ≥ 26.0 kg/m2 and ≤ 42.0 kg/m2

Exclusion Criteria

I am able to understand and willing to follow the study's requirements.
Evidence of fetal malformation
Active substance abuse with alcohol or drugs by self-report
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of the dietary-lifestyle behavioral intervention through focus groups to incorporate feedback on the program

1 year

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)

21 weeks
12 sessions (in-person, virtual, or phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including glucose monitoring and weight gain assessment

4 weeks

Treatment Details

Interventions

  • Nutrition-behavior lifestyle program
Trial Overview The study tests a culturally tailored nutrition-behavior lifestyle program aimed at preventing excessive weight gain and improving blood sugar control during pregnancy. Delivered by community health workers (CHWs), it promotes eating plant-based foods over processed ones through a randomized controlled trial involving the local Latino community.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Nutrition-behavior lifestyle program groupExperimental Treatment1 Intervention
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
Group II: Standard care groupActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sansum Diabetes Research Institute

Lead Sponsor

Trials
39
Recruited
2,300+

Findings from Research

The implementation of a structured model of care for gestational diabetes in regional Australian sites significantly increased the proportion of women receiving best practice nutrition therapy from 3.5% to 87.8% at Site 1, demonstrating the efficacy of the approach.
Despite challenges such as organizational barriers, the project successfully reduced the number of women requiring medication for gestational diabetes, indicating improved management of the condition through enhanced support and resources.
Clinically relevant improvements achieved from a facilitated implementation of a gestational diabetes model of care.Wilkinson, SA., McCray, SJ., Kempe, A., et al.[2019]
A group-based lifestyle modification program for women with previous gestational diabetes showed some improvement in dietary quality, particularly in dairy consumption, but overall diet quality remained low after 12 months.
While the intervention group reduced alcohol intake by 2% and improved dairy scores, the total Australian Recommended Food Score (ARFS) did not significantly change, indicating a need for more effective strategies to enhance dietary quality in this population.
The effect of a diabetes prevention program on dietary quality in women with previous gestational diabetes.O'Reilly, S., Versace, V., Mohebbi, M., et al.[2020]
Nutrition therapy is essential for managing gestational diabetes mellitus (GDM), and guidelines have been developed by leading organizations to provide evidence-based recommendations for pregnant women with GDM.
While it is recognized that nutrition needs during pregnancy are similar for women with and without diabetes, there is still limited evidence supporting specific nutrition practices for GDM, highlighting the need for further research in this area.
Recommendations for nutrition best practice in the management of gestational diabetes mellitus. Executive summary (1).[2007]

References

Clinically relevant improvements achieved from a facilitated implementation of a gestational diabetes model of care. [2019]
The effect of a diabetes prevention program on dietary quality in women with previous gestational diabetes. [2020]
Recommendations for nutrition best practice in the management of gestational diabetes mellitus. Executive summary (1). [2007]
Nutrition therapy recommendations for the management of adults with diabetes. [2022]
Impact of gestational diabetes mellitus nutrition practice guidelines implemented by registered dietitians on pregnancy outcomes. [2022]
Effect of Dietary Intervention Designed with Behavior Change Wheel on Compliance with Dietary Control in Women with Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial. [2023]
Gestational diabetes mellitus: a kitchen table approach. [2009]
Gestational diabetes and nutritional recommendations. [2019]
Impact of dietary counseling on the perception of diet in patients with gestational diabetes mellitus. [2022]
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