Lifestyle Counseling for Pregnancy

(BETTER Trial)

Overseen By Bilgay Izci Balserak, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Hypoglycemics, Stimulants, Sleeping aids

Disqualifiers: Multiple gestations, Sleep disorders, Mood disorders, Gestational diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16-36 gestational weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a special counseling program, called Better (a behavioral intervention for maternal glucose metabolism), can improve blood sugar levels in African American pregnant women. Researchers will compare two groups: one will receive guidance on sleep habits and behavior, while the other will get general pregnancy information. The goal is to determine if personalized lifestyle advice can effectively manage glucose levels during pregnancy. This trial suits African American women expecting one baby, who are between 16 and 22 weeks pregnant, and who are overweight or obese. Participants should receive prenatal care at the University of Illinois Hospital clinics.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance maternal health care practices.

Will I have to stop taking my current medications?

The trial requires that participants do not take hypoglycemic medications (medications that lower blood sugar) or stimulant medications, and they should not be using sleeping aids.

What prior data suggests that this behavioral intervention is safe for maternal glucose metabolism?

Research has shown that lifestyle counseling for pregnant women is generally safe. Studies have found that advice on diet and exercise is well-received. For instance, a study involving over 8,500 pregnant women showed that these lifestyle changes did not increase negative health events. Another study found that lifestyle counseling can even lower certain risks, such as low blood sugar in newborns. Overall, evidence suggests that lifestyle counseling is a safe option for pregnant women seeking to improve their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Better" lifestyle counseling approach for pregnancy because it focuses on improving sleep hygiene and incorporating cognitive-behavioral principles. Unlike traditional prenatal care that might emphasize general health and nutrition, this method specifically targets sleep and mental well-being, which are crucial yet often overlooked aspects of a healthy pregnancy. By addressing these areas, researchers hope to enhance overall maternal health and potentially improve pregnancy outcomes. This approach is about empowering expectant mothers with practical strategies to manage stress and improve sleep quality, which could lead to better health for both mother and baby.

What evidence suggests that this trial's treatments could be effective for promoting maternal glucose metabolism in African American women?

Research shows that lifestyle counseling during pregnancy can significantly improve how the body handles sugar. In this trial, participants in the intervention arm will receive lifestyle counseling, which previous studies have shown can lower the risk of developing gestational diabetes by nearly half compared to those who didn't receive it. Another study demonstrated that these interventions helped control weight gain and prevent health issues during pregnancy. While some studies found only a small effect on sugar levels, the overall evidence supports better outcomes for pregnant women. These findings suggest that lifestyle counseling can be crucial for promoting healthier pregnancies, especially for those at risk of health challenges. ^{2 4 6 7 8}

Who Is on the Research Team?

Bilgay Izci Balserak, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for African American women who are between 16 and 22 weeks pregnant, overweight or obese, with a single baby. They must be receiving prenatal care at UIHHSS' OB clinics and speak English. It's not for those working night shifts, with sleep or mood disorders, early gestational diabetes, drug/alcohol issues, or taking certain medications.

Inclusion Criteria

I am pregnant and between 16 and 22 weeks along.

Singleton gestation

Able to understand, speak and write in English

Exclusion Criteria

Active drug abuse/excessive alcohol intake

Glycated Hemoglobin (HbA1c) ≥ 6.5%

I am taking medication to lower my blood sugar.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including fasting glucose and sleep quality measurements

16-22 gestational weeks

Treatment

Participants receive either the BETTER intervention or attention control focusing on sleep hygiene and cognitive-behavioral principles

16-36 gestational weeks

Follow-up

Participants are monitored for maternal-fetal outcomes and glucose metabolism post-delivery

up to 3 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Better
• Birth Prep

Trial Overview

The study tests a behavioral intervention tailored to improve glucose metabolism in African American pregnant women. Participants will receive lifestyle counseling aimed at promoting better sleep and physical activity habits during pregnancy.

How Is the Trial Designed?

Group I: Intervention arm Active Control 1 Intervention

Sleep hygiene practices and cognitive-behavioral principles

Group II: Attention control Placebo Group 1 Intervention

Training about pregnancy issues

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Office of Research on Women's Health (ORWH)

Collaborator

Trials

34

Recruited

36,300+

Office of Behavioral and Social Sciences Research (OBSSR)

Collaborator

Trials

6

Recruited

8,100+

Published Research Related to This Trial

The lifestyle counseling intervention for pregnant women at high risk of gestational diabetes mellitus (GDM) did not significantly reduce the incidence of GDM, with 15.8% in the intervention group developing GDM compared to 12.4% in the usual care group.

However, the intervention successfully reduced newborn birthweight by an average of 133 grams and decreased the proportion of large-for-gestational-age (LGA) newborns, indicating that lifestyle changes can positively impact neonatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary prevention of gestational diabetes mellitus and large-for-gestational-age newborns by lifestyle counseling: a cluster-randomized controlled trial. Luoto, R., Kinnunen, TI., Aittasalo, M., et al.[2022]

In a study of 251 women at high risk for gestational diabetes mellitus (GDM), lifestyle interventions reduced the risk of GDM by 46.9% and pregnancy-induced hypertension (PIH) by 74.2% compared to a control group.

The interventions improved women's understanding of pregnancy-related health, helped manage weight gain, and prevented metabolic issues, emphasizing the importance of early screening and lifestyle changes for high-risk pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle interventions to prevent adverse pregnancy outcomes in women at high risk for gestational diabetes mellitus: a randomized controlled trial. Xu, J., Lin, X., Fang, Y., et al.[2023]

A study involving 180 gestational diabetes mellitus (GDM) patients showed that interdisciplinary health education combined with personalized nutrition significantly reduced fasting blood glucose (FPG), two-hour postprandial glucose (2hPBG), and glycated hemoglobin (HbA1C) levels compared to routine care.

The intervention also led to improved psychological scores (SDS and SAS) after treatment, indicating better overall management of GDM, although the difference in pregnancy outcomes between the two groups was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of interdisciplinary and diversified health education combined with personalized nutrition intervention on FPG, 2hPG, SDS, SAS scores and the pregnancy outcomes of gestational diabetes mellitus. Zhu, GH., Xu, Y., Zou, L., et al.[2021]

In a study of 492 women at high risk for gestational diabetes, lifestyle counseling did not lead to significant differences in gestational weight gain or perinatal outcomes compared to usual care.

The prevalence of gestational diabetes was high in both groups, with 44.8% in the intervention group and 48.1% in the control group, suggesting that early impaired glucose metabolism may limit the effectiveness of lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a lifestyle intervention during pregnancy-findings from the Finnish gestational diabetes prevention trial (RADIEL). Rönö, K., Grotenfelt, NE., Klemetti, MM., et al.[2019]

A study involving 433 overweight and obese pregnant women found that nutritional counseling significantly reduced total sugar intake by an average of 15 g/day and total energy consumption by 125 kcal/day compared to routine counseling.

The intervention was particularly effective in decreasing consumption of high-sugar foods like table sugar, sweets, and soft drinks, suggesting that targeted dietary education can help manage sugar intake during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Intervention of Dietary Counseling for Overweight and Obese Pregnant Women in the Consumption of Sugars and Energy. Anleu, E., Reyes, M., Araya B, M., et al.[2020]

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]

The study involved 83 pregnant women with abnormal glucose metabolism, who were divided into two groups to compare traditional food exchange serving (FES) and food exchange serving based on glycemic load (FES + GL). The FES + GL group showed a significant reduction in daily food glucose load and improved fasting and postprandial glucose levels after nutrition therapy.

While both nutrition therapies improved maternal and neonatal outcomes, the FES + GL approach was more effective in lowering blood glucose levels, suggesting it may be a better option for managing glucose metabolism during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of different nutrition therapies in pregnancy with abnormal glucose metabolism]. Ma, WJ., Qi, BH., Zhang, YJ., et al.[2012]

The Coaching Program on Comprehensive Lifestyle Modification significantly improved self-care behaviors and reduced depression, fasting blood sugar, and HbA1C levels in pregnant women with gestational diabetes, based on a study of 68 participants (34 in each group) over 4 weeks.

Despite the positive outcomes in health metrics, the program did not significantly enhance participants' knowledge about gestational diabetes, indicating that educational components may need further development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of a coaching program on comprehensive lifestyle modification for women with gestational diabetes mellitus]. Ko, JM., Lee, JK.[2022]

A lifestyle intervention focusing on diet, physical activity, and weight control significantly reduced the incidence of gestational diabetes mellitus (GDM) among high-risk pregnant women, with 281 participants analyzed from a larger group of 1822.

Women who received the lifestyle intervention had a lower risk of adverse maternal outcomes compared to those who only received usual prenatal care, indicating the effectiveness of tailored lifestyle changes during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention to prevent gestational diabetes mellitus and adverse maternal outcomes among pregnant women at high risk for gestational diabetes mellitus. Lin, X., Yang, T., Zhang, X., et al.[2021]

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Lifestyle Counseling for Pregnancy (BETTER Trial)

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