Better Lifestyle Counseling for African American Women During Pregnancy (BETTER)

University of Illinois

Status: Enrolling

Conditions: Fitness Trackers; Sleep Disparities; Overweight or Obesity; Pregnancy Related; Stress, Psychological; Sleep Disturbances; African Americans; Exercise; Sleep Hygiene; Pregnancy Complications; Disparities in Pregnancy Complications; Diversity

Treatments: Behavioral: Birth Prep; Behavioral: Better

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05234125

R01MD015724 (U.S. NIH Grant/Contract)

2021-0918

Details and patient eligibility

About

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.

Full description

This is a randomized controlled parallel-group trial with two arms. Potential subjects will be identified from the OB Clinics at UI health systems, the University of Illinois at Chicago. After baseline assessments, the subjects will be randomized to the attention control arm (Birth-Prep) or BETTER intervention.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• African American pregnant woman.
• Women between 16 and 22 GWs.
• Overweight or obese - pregravid Body Mass Index >25.0 kg/m2.
• Singleton gestation.
• Established prenatal care at The University of Illinois Hospital & Health Sciences.
• System Obstetric (UIHHSS' OB) clinics. Able to understand, speak and write in English.

Exclusion criteria

• Multiple gestations.
• Night-shift work.
• Diagnosed sleep disorders.
• Known fetal chromosomal or anatomical abnormalities.
• Diagnosed mood disorders.
• Gestational diabetes in early pregnancy.
• Glycated Hemoglobin (HbA1c) ≥ 6.5%.
• Hypoglycemic medications.
• Stimulant medication or taking a sleeping aid.
• Active drug abuse/excessive alcohol intake.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Intervention arm

Active Comparator group

Description:

Sleep hygiene practices and cognitive-behavioral principles

Treatment:

Behavioral: Better

Attention control

Placebo Comparator group

Description:

Training about pregnancy issues

Treatment:

Behavioral: Birth Prep