Lifestyle Changes for Gestational Diabetes

(TLC Trial)

Not currently recruiting at 1 trial location

Overseen By Amber R Ivins, MS

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Type 2 diabetes, Multiple gestation, Major fetal anomaly, Serious medical co-morbidity, Serious psychiatric illness, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6-10 sessions

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether group prenatal care focused on lifestyle changes (TLC Group Prenatal Care) can improve health outcomes for women at high risk for gestational diabetes and their babies. It compares this approach to traditional one-on-one prenatal visits. English-speaking women who are less than 16 weeks pregnant and have two or more risk factors for gestational diabetes, such as a family history of diabetes or a previous large baby, may be suitable candidates. Participants will attend group sessions to learn about pregnancy, healthy eating, and exercise. As an unphased trial, this study provides a unique opportunity to explore innovative prenatal care methods that could enhance health outcomes for mothers and babies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that TLC Group Prenatal Care is safe for pregnant women?

Research shows that the Targeted Lifestyle Change (TLC) Group Prenatal Care is generally manageable for participants. This program emphasizes lifestyle changes, such as exercise and nutrition advice, while providing education and support in a group setting. Studies have found that this type of group prenatal care can lead to better health outcomes. For instance, participants often gain less weight during pregnancy and are more likely to exclusively breastfeed six weeks after giving birth.

Because the program focuses on lifestyle changes rather than medication, it is considered safe with a very low risk of side effects. Studies have reported no serious side effects, indicating it is a well-tolerated option for expectant mothers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TLC Group Prenatal Care approach for gestational diabetes because it emphasizes collaborative learning and support, which is quite different from traditional, individual prenatal care. This method involves group sessions where pregnant women with risk factors for gestational diabetes can learn about and discuss exercise, nutrition, and behavioral health under the guidance of healthcare professionals. This group dynamic not only fosters a supportive community but also promotes a deeper understanding of lifestyle changes, potentially leading to better management of gestational diabetes. By focusing on education and peer support, this approach aims to empower women to take proactive steps in managing their condition.

What evidence suggests that TLC Group Prenatal Care is effective for gestational diabetes?

Research has shown that group prenatal care, such as the Targeted Lifestyle Change (TLC) program, can improve health outcomes for mothers and their babies. In this trial, participants will join either the TLC Group Prenatal Care or Traditional Prenatal Care. Studies have found that women in group prenatal care often gain less weight during pregnancy and are more likely to exclusively breastfeed six weeks postpartum. TLC sessions emphasize lifestyle changes, such as healthy eating and exercise, which are crucial for managing the risk of gestational diabetes. Although the risk of developing gestational diabetes is similar in both traditional and group care, group care can enhance overall pregnancy health, making TLC a promising option for those at high risk. ^{1 2 5 6 7}

Who Is on the Research Team?

Ebony B Carter, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for English-speaking women under 16 weeks pregnant, at high risk for gestational diabetes due to factors like being overweight, inactive, having a family history of diabetes or certain ethnic backgrounds. They must be able to attend group prenatal visits and agree to random assignment in the study.

Inclusion Criteria

You have two or more of the following: high body mass index (BMI), physical inactivity, a close family member with diabetes, belong to a high-risk race or ethnicity, had a previous large baby, had gestational diabetes before, have high blood pressure, low levels of "good" cholesterol or high triglycerides, polycystic ovarian syndrome, high blood sugar levels, history of heart disease, can attend group prenatal visits on specific days and times, are willing to be randomly assigned to a group, and can provide informed consent.

English speaking

≤16 weeks' gestation

Exclusion Criteria

You have tested positive for high blood sugar during early pregnancy.

I have type 2 diabetes.

Multiple gestation (require extra care)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Targeted Lifestyle Change Group Prenatal Care (TLC) starting in the late first trimester or early second trimester, focusing on education about pregnancy, exercise/nutrition, and behavioral health.

6-10 sessions

6-10 visits (in-person)

Follow-up

Participants are monitored for maternal and neonatal outcomes, including psychosocial stress and depression, up to 12 weeks postpartum.

4-12 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• TLC Group Prenatal Care

Trial Overview The study is testing Targeted Lifestyle Change Group Prenatal Care (TLC) to see if it improves outcomes for mothers and babies at risk of gestational diabetes. Women will be randomly placed into groups where they receive this specialized care during pregnancy.

How Is the Trial Designed?

Group I: TLC Group Prenatal Care Experimental Treatment 1 Intervention

TLC will start in the late first trimester or early second trimester and run for \~6-10 sessions. Groups of 2-10 consented women, with two or more GDM risk factors, will meet under the supervision of an obstetric provider (nurse practitioner or MD) and co-facilitator (health educator, nutritionist, or nurse) for two-hour sessions. A major focus of TLC will be education, and much of each visit will be spent on pregnancy, exercise/nutrition education, and behavioral health.

Group II: Traditional Prenatal Care Active Control 1 Intervention

Subjects randomized to routine care will receive their prenatal care with their primary obstetric provider. Patients are seen for 10-15 minutes every four weeks until 28 weeks' gestation, every two weeks (or more by provider discretion) until 37 weeks and weekly until delivery. Visits focus on routine screening tests and prenatal care. Traditional care participants will receive a phone call once a month, until 28 weeks gestation, from a nurse practitioner to check-in on pregnancy goals, healthy eating, and exercise. Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes.

TLC Group Prenatal Care is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Group Prenatal Care for:

• Prenatal care for high-risk pregnancies
• Prevention of gestational diabetes mellitus (GDM)

Approved in European Union as CenteringPregnancy for:

• Prenatal care for low-risk pregnancies
• Improvement of maternal and neonatal outcomes

Approved in Canada as Group Prenatal Care for:

• Prenatal care for high-risk pregnancies
• Prevention of preterm birth

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

A study involving 700 women with gestational diabetes showed that a shared care (SC) approach with lifestyle modifications led to a lower rate of macrosomia (11.2% vs. 17.5%) compared to usual care, indicating improved pregnancy outcomes.

While the SC group had a lower average birth weight and reduced macrosomia risk, they also experienced a higher rate of pregnancy-induced hypertension (PIH), suggesting that while lifestyle changes can be beneficial, they may also carry some risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes. Yang, X., Tian, H., Zhang, F., et al.[2022]

Diabetic pregnant women (gravidas) in Centering® group care had significantly lower mean fasting blood sugar levels (91.0 mg/dL) compared to those receiving standard prenatal care (105.5 mg/dL), indicating better immediate glycemic control.

Patients in the Centering® group reported higher satisfaction scores regarding their ability to see a physician and reduced waiting times, suggesting that this care model may enhance the overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycemic control, compliance, and satisfaction for diabetic gravidas in centering group care. Parikh, LI., Jelin, AC., Iqbal, SN., et al.[2019]

Integrating group-based lifestyle sessions (GBLS) into prenatal care shows promise for managing gestational weight gain, with positive feedback from both care providers and patients.

Preliminary data from two feasibility studies suggest that while GBLS can positively influence weight gain patterns, there is a need for more research on its implementation and effectiveness in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group-based lifestyle sessions for gestational weight gain management: a mixed method approach. Harden, SM., Beauchamp, MR., Pitts, BH., et al.[2014]

The Gestational Diabetes Group Program (GDGP) effectively improved diabetes self-management education for pregnant women, leading to significant increases in knowledge and empowerment regarding their condition.

Participants in the GDGP reported high satisfaction levels and experienced optimal pregnancy outcomes, demonstrating the program's efficacy in supporting underserved populations through an interdisciplinary care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Gestational Diabetes Group Program. Nasso, J., McCloskey, C., Nordquist, S., et al.[2020]

Women with gestational diabetes who successfully managed their condition through lifestyle modifications were generally younger and had a lower pre-pregnancy body mass index compared to those who required medication, suggesting that these factors may influence glycemic control outcomes.

The study identified specific diagnostic parameters, such as glucose challenge test and fasting oral glucose tolerance test results, that can help predict which women are likely to need anti-diabetic medications instead of achieving control through lifestyle changes alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of women with gestational diabetes who failed to achieve glycemic control by lifestyle modifications. Krispin, E., Ashkenazi Katz, A., Shmuel, E., et al.[2021]

A systematic review of 13 randomized controlled trials involving 3745 women with previous gestational diabetes found that lifestyle interventions reduced the incidence of type 2 diabetes by 24% compared to standard care.

Despite the positive findings, caution is advised due to evidence of publication bias, which may affect the reliability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention for the prevention of type 2 diabetes in women with prior gestational diabetes: A systematic review and meta-analysis. Retnakaran, M., Viana, LV., Kramer, CK.[2023]

In a study of 1035 pregnant women, 82.6% achieved successful glycemic control after just two weeks of lifestyle changes, including diet and exercise, highlighting the effectiveness of these interventions for managing gestational diabetes mellitus (GDM).

Younger women (under 35) and those with a pre-pregnancy BMI under 25 had significantly higher rates of glycemic control, suggesting that age and weight management are important factors in the success of lifestyle interventions for GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Lifestyle Changes in Glycemic Control among Pregnant Women with Gestational Diabetes Mellitus. Le, DC., Vu, TB., Tran, TN., et al.[2023]

Lifestyle modifications aimed at weight loss and improving insulin sensitivity can effectively prevent or delay type 2 diabetes (T2DM) in high-risk populations, including women with gestational diabetes mellitus (GDM).

There is a need for tailored lifestyle intervention programs that begin during pregnancy and continue postpartum, as pharmacotherapy may not be suitable for women of reproductive age, and understanding the unique challenges faced by young mothers is crucial for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for diabetes prevention before and after pregnancy in women with GDM. Ferrara, A., Ehrlich, SF.[2022]

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]

Women with a history of gestational diabetes mellitus (GDM) are at an increased risk for developing type 2 diabetes, highlighting the importance of preventive measures.

The pilot of the National Diabetes Prevention Program lifestyle change program specifically targeted women with GDM, providing insights into recruitment challenges and participation that can inform future implementations of similar programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking Postpartum and Parenting Women With a National Diabetes Prevention Program: Recruitment Efforts, Challenges, and Recommendations. Gómez, ML., Hieronymus, LB., Ashford, KB., et al.[2020]

The study developed reliable and valid measures to assess psychosocial factors influencing physical activity and diet in women with a history of gestational diabetes mellitus (GDM), based on a survey of 160 participants.

These measures demonstrated good internal reliability and construct validity, which will help in evaluating behavior change interventions aimed at promoting healthy lifestyles in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and Validity of Measures for Investigating the Determinants of Health Behaviors Among Women With a History of Gestational Diabetes. Smith, BJ., Cheung, NW., Najnin, N., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04090307

Targeted Lifestyle Change Group Prenatal Care (TLC) Long term, the investigator aims to test the central hypothesis that those in TLC will have better maternal and neonatal outcomes than those in TC.

2. researchforme.unc.edu researchforme.unc.edu/study-details?rcid=5364

Targeted lifestyle change (TLC) group prenatal care for ... The purpose of this study is to find out if a type of group prenatal care focused on lifestyle changes can help improve the health of pregnant people who are ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10466168/

Group vs Individual Prenatal Care and Gestational ... These findings suggest that individuals receiving both group prenatal care and traditional individual prenatal care had similar risk of developing GD.

4. ysph.yale.edu ysph.yale.edu/news-article/group-prenatal-care-intervention-shows-promising-results-in-reducing-adverse-pregnancy-outcomes/

Group Prenatal Care Intervention Shows Promising Results in ... Key Findings: · Reduced gestational weight gain. · Increased likelihood of exclusive breastfeeding at six weeks postpartum (44.4% group members vs ...

5. diabetesjournals.org diabetesjournals.org/diabetes/article/74/2/138/157459/Innovating-Diabetes-Care-in-Pregnancy-Do-Group

Do Group Care Models Improve Outcomes and Equity? A ... There is compelling evidence that SMAs improve glycemic control for nonpregnant patients with diabetes, GPC reduces Black and White health ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04090307?term=fetal&viewType=Table&checkSpell=&rank=8

Targeted Lifestyle Change Group Prenatal Care (TLC) A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04090307/targeted-lifestyle-change-group-prenatal-care

Targeted Lifestyle Change Group Prenatal Care To conduct a randomized trial to determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal and neonatal outcomes ...