Lifestyle Counseling for Pregnancy

(BETTER Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Bilgay Izci Balserak, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Illinois at Chicago

Must not be taking: Hypoglycemics, Stimulants, Sleeping aids

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

Trial Summary

What is the purpose of this trial?

The purpose of this randomized controlled trial is to establish the effectiveness of a culturally targeted and individually tailored behavioral intervention to promote maternal glucose metabolism in African American women.

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 data supports the effectiveness of the treatment Lifestyle Counseling for Pregnancy?

Research shows that lifestyle counseling, including dietary guidance and health education, can help prevent gestational diabetes (a type of diabetes that develops during pregnancy) and reduce the risk of having a baby with high birthweight in women at high risk for these conditions.

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Is lifestyle counseling safe for pregnant women?

Research on lifestyle counseling for pregnant women, especially those at high risk for gestational diabetes, shows it is generally safe. These studies focus on improving diet and health education without reporting any significant safety concerns.

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How is the Lifestyle Counseling treatment for pregnancy different from other treatments?

Lifestyle Counseling for pregnancy is unique because it focuses on modifying daily habits, like diet and exercise, to prevent gestational diabetes and high birthweight in newborns, rather than using medication, which may not be suitable for pregnant women.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Illinois at Chicago Chicago, IL

Who Is Running the Clinical Trial?

University of Illinois at Chicago Lead Sponsor

National Institute on Minority Health and Health Disparities (NIMHD) Collaborator

Office of Research on Women's Health (ORWH) Collaborator

Office of Behavioral and Social Sciences Research (OBSSR) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of a lifestyle intervention during pregnancy-findings from the Finnish gestational diabetes prevention trial (RADIEL). [2019] To assess the effect of lifestyle counseling on perinatal outcomes among women at high risk for gestational diabetes.

2. United States 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. [2022] Our objective was to examine whether gestational diabetes mellitus (GDM) or newborns' high birthweight can be prevented by lifestyle counseling in pregnant women at high risk of GDM.

3. Switzerland 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. [2023] To examine the effects of lifestyle interventions, including dietary guidance, health education and weight management, on pregnancy outcomes in women at high risk of gestational diabetes mellitus (GDM).

4. Korea (South) pubmed.ncbi.nlm.nih.gov

[Effects of a coaching program on comprehensive lifestyle modification for women with gestational diabetes mellitus]. [2022] The purpose of this study was to investigate the effects of using a Coaching Program on Comprehensive Lifestyle Modification with pregnant women who have gestational diabetes.

5. Poland 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. [2021] This study aimed to explore the effect of interdisciplinary and diversified health education combined with personalized nutrition intervention on FPG, 2hPG, SDS, SAS scores and pregnancy outcome of gestational diabetes mellitus (GDM).

6. England 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. [2021] We assessed the effects of a lifestyle intervention on gestational diabetes mellitus (GDM) incidence and risk of adverse maternal outcomes among pregnant women at high risk for GDM.

7. Switzerland 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. [2020] Evaluate if an intervention based on nutritional counseling decreases total sugars and energy consumption in overweight and obese pregnant women, compared to their previous consumption and compared to women who only received routine counseling.

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Strategies for diabetes prevention before and after pregnancy in women with GDM. [2022] Interventions for lifestyle modification promoting weight loss and pharmacotherapy interventions for improving insulin sensitivity have been shown to be effective in preventing or delaying the onset of type 2 diabetes (T2DM) in high risk populations. Women with gestational diabetes mellitus (GDM) are at high risk for T2DM, but only two trials have assessed the feasibility of diabetes prevention in this population. We present evidence supporting an intervention with lifestyle modification for women with GDM that would begin during pregnancy and continue through the postpartum period, as pharmacotherapy interventions may not be appropriate for pregnant women or women of reproductive age who could again become pregnant. Young women with GDM may not be aware of their diabetes risk and may perceive difficulty in changing behaviors. Thus, novel approaches will be necessary to translate the lifestyle modification programs previously proven effective among older women with impaired glucose tolerance to younger women with a recent history of GDM, particularly those with normal glucose tolerance postpartum. Understanding barriers to increasing physical activity and adopting a healthy diet and finding strategies for the successful integration of lifestyle modification programs into the busy schedules of women with young children remain priorities for future research.

9. China pubmed.ncbi.nlm.nih.gov

[Application of different nutrition therapies in pregnancy with abnormal glucose metabolism]. [2012] To explore the effect of different nutrition therapies on abnormal glucose metabolism during pregnancy and pregnancy outcomes.