Nutrition-Lifestyle Therapy for Gestational Diabetes

Overseen By Brandon Cobb, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sansum Diabetes Research Institute

Must not be taking: Corticosteroids, Antipsychotics

Disqualifiers: Type 1 diabetes, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 21 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a nutrition and lifestyle program designed to help pregnant Latina women manage type 2 diabetes. The program aims to improve blood sugar control and prevent excessive weight gain during pregnancy by promoting a diet rich in fruits, vegetables, nuts, and grains. Participants engage with community health workers through personalized sessions. Pregnant women who identify as Hispanic or Latina, have type 2 diabetes, and struggle with weight management may be well-suited for this trial. As an unphased trial, participants receive personalized support and contribute to valuable research that may enhance health outcomes for pregnant women with type 2 diabetes.

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 prior data suggests that this nutrition-behavior lifestyle program is safe for pregnant Latina women with T2D?

Research has shown that lifestyle programs are generally safe and can improve diet quality in women who have had gestational diabetes. These programs typically emphasize healthier eating and exercise. Other studies have found that similar lifestyle changes can help prevent gestational diabetes in women at high risk.

The nutrition and behavior program in this trial involves no medication. Participants meet with community health workers to learn about healthy eating and exercise during pregnancy. Similar lifestyle programs have reported no serious side effects. This program encourages healthier choices, such as eating more fruits, vegetables, nuts, and grains. It offers a safe way to improve blood sugar control and manage weight during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition-behavior lifestyle program for gestational diabetes because it takes a holistic approach that combines education with practical lifestyle changes. Unlike standard treatments that often focus solely on medication or basic dietary advice, this program offers personalized sessions where participants learn about food groups, carbohydrate management, and stress coping techniques tailored specifically for pregnancy. The program also emphasizes communal support and empowered communication with healthcare providers, aiming to equip expectant mothers with the knowledge and skills they need to manage their condition effectively and independently. This comprehensive and supportive approach could potentially lead to better long-term health outcomes for both mothers and their babies.

What evidence suggests that this nutrition-behavior lifestyle program is effective for gestational diabetes?

Research has shown that lifestyle changes during pregnancy can help manage blood sugar levels in women with gestational diabetes (GDM). For example, studies have found that a healthy diet and regular exercise can improve blood sugar levels and prevent excessive weight gain. Specifically, diet plans like the DASH diet, which emphasizes fruits, vegetables, and whole grains, have proven helpful. In this trial, participants in the Nutrition-behavior lifestyle program group will engage in a community-based program designed to encourage lifestyle changes. These programs have proven to be as effective, or even more effective, than standard care, helping pregnant women achieve better health outcomes. ^{2 4 6 7 8}

Who Is on the Research Team?

Rachyl Pines, PhD

Principal Investigator

Sansum Diabetes Research Insititute

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Nutrition-behavior lifestyle program group Experimental Treatment 1 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 group Active Control 1 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.

Who Is Running the Clinical Trial?

Sansum Diabetes Research Institute

Lead Sponsor

Trials

39

Recruited

2,300+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for nutrition best practice in the management of gestational diabetes mellitus. Executive summary (1). [2007]

Dietary counseling for patients with gestational diabetes mellitus (GDM) was found to be effective, as most patients understood the dieticians' suggestions and recognized their previous unhealthy eating habits.

Despite the positive reception of dietary advice, many patients struggled to implement recommended practices like frequent meals, often due to conflicting information from mass media.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of dietary counseling on the perception of diet in patients with gestational diabetes mellitus. Kishimoto, M., Kato, R., Oshiba, Y.[2022]

There is no one-size-fits-all meal plan for people with diabetes; nutrition therapy must be tailored to each individual's health goals, preferences, and circumstances.

Effective nutrition interventions should focus on a variety of minimally processed, nutrient-dense foods and provide practical tools for sustainable behavior change in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition therapy recommendations for the management of adults with diabetes. Evert, AB., Boucher, JL., Cypress, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A clinical trial involving 215 women with gestational diabetes showed that following specific nutrition practice guidelines led to less insulin use and better control of glycated hemoglobin levels in diabetes clinic settings compared to usual care.

Women receiving care under the nutrition practice guidelines had a lower proportion of elevated glycated hemoglobin levels (8.1%) compared to those in the usual care group (13.6%), suggesting that these guidelines may improve management of gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of gestational diabetes mellitus nutrition practice guidelines implemented by registered dietitians on pregnancy outcomes. Reader, D., Splett, P., Gunderson, EP.[2022]

This study is a randomized controlled trial involving 60 women with gestational diabetes mellitus (GDM), aiming to improve dietary compliance and glucose control through a behavior change wheel (BCW) intervention compared to general dietary management.

The trial seeks to determine if the BCW-based dietary intervention can lead to better maternal glucose metabolism and reduce adverse pregnancy outcomes, potentially establishing a new approach for self-management in women with GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Xu, J., Wu, Y., Zou, Z., et al.[2023]

The Healthy Start for Mom & Me program effectively addresses gestational diabetes in disadvantaged communities by focusing on education, community involvement, and building local capacity, which is crucial for at-risk women and teens in Winnipeg.

A qualitative case study from 1999 highlighted that the program's health education practices are tailored to the specific needs of marginalized women, improving service providers' understanding of participants' life contexts and evolving the role of community dietitians in prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational diabetes mellitus: a kitchen table approach. Vogel, E., Anderson, K., Raine, K., et al.[2009]

Medical nutrition therapy is essential for managing gestational diabetes mellitus (GDM), focusing on meeting the nutritional needs of both mother and fetus while maintaining optimal blood sugar levels.

Current guidelines recommend a balanced diet for women with GDM, but there is still debate over the best dietary compositions and weight management strategies, highlighting the need for further research to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational diabetes and nutritional recommendations. Gunderson, EP.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10672732/

Effectiveness of Lifestyle Interventions during Pregnancy on ... Conclusions: The results of this study support the efficacy of lifestyle interventions during pregnancy for preventing GDM in high-risk women if an exercise ...

2. withpower.com withpower.com/trial/phase-diabetes-mellitus-2024-b9a4a

Nutrition-Lifestyle Therapy for Gestational Diabetes Trial Overview The study tests a culturally tailored nutrition-behavior lifestyle program aimed at preventing excessive weight gain and improving blood sugar ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/10641955.2025.2552693

Full article: Evaluation of a lifestyle intervention for women ... Most GDM women can achieve good blood glucose control through lifestyle intervention (Citation10,Citation11). The effectiveness of lifestyle interventions ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831324001649

Effects of Dietary Approaches and Exercise Interventions ... Our findings suggest that the DASH diet and low GI diet, and resistance exercise may be beneficial for maternal outcomes in pregnancies with GDM.

5. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-022-02038-9

Community-based non-pharmacological interventions for ... Community-based non-pharmacological interventions are more effective than placebo; and are more or as effective as usual care.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11216049/

Digital therapeutics-based lifestyle intervention for gestational ... Primary outcomes include the incidence of GDM at 24–28 weeks gestation and gestational weight gain (GWG). Secondary outcomes comprise ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01489163

Lifestyle Intervention Program for Women With Gestational ... A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers ...

8. diabetesjournals.org diabetesjournals.org/care/article/30/Supplement_2/S188/23903/Medical-Nutrition-Therapy-and-Lifestyle

Medical Nutrition Therapy and Lifestyle Interventions Outcome measures that help guide adjustments to the food plan are: weight changes, blood glucose and ketone levels, and review of food records.