Health TrialsbyHealthPanel

Better Lifestyle Counseling for African American Women During Pregnancy

ConditionsOverweight or ObesityPregnancy RelatedSleep DisturbancesSleep HygienePregnancy ComplicationsDiversityStress, PsychologicalFitness TrackersExerciseAfrican AmericansDisparities in Pregnancy ComplicationsSleep Disparities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversity of Illinois at Chicago

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

African American pregnant woman.

Women between 16 and 22 GWs.

Overweight or obese - pregravid Body Mass Index >25.0 kg/m2.

Singleton gestation.

Disqualifiers

Multiple gestations.

Night-shift work.

Diagnosed sleep disorders.

Known fetal chromosomal or anatomical abnormalities.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Better

    Behavioral

    It is a nonpharmacologic sleep intervention to improve maternal glucose metabolism in African American Pregnant Women (AAPW). Sleep BETTER is composed of sleep hygiene practices and cognitive-behavioral principles.

  • Birth Prep

    Behavioral

    The intervention involves training about pregnancy-related issues, and follow up

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Intervention armActive comparator 1 intervention
Group B: Attention controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fasting Glucose at baseline

A fasting blood sample for glucose will be collected

Time frame
16-22 Gestational Weeks (GWs)
2

Fasting Glucose

A fasting blood sample for glucose will be collected

Time frame
28-32 Gestational Weeks (GWs)

Secondary outcomes

1

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline

Insulin Resistance

Time frame
16-22 Gestational Weeks
2

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Insulin Resistance

Time frame
28-32 Gestational Weeks
3

Glucose Area Under the Curve at baseline

Glucose tolerance

Time frame
16-22 Gestational Weeks
4

Glucose Area Under the Curve

Glucose tolerance

Time frame
28-32 Gestational Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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