Clinical trial NCT03416010: Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women
Official title: Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A-RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Disturbances
Depression
Pregnancy Late
Post-Partum Depression
Anxiety
Nutritional Deficiency
Keywords: emotional distress pregnancy disparities minority depression
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: New York University
name: Jacobi Medical Center
name: Boston College
name: University of Arizona
name: Drexel University
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: University of South Florida
First posted: 2018-01-30
Enrollment: 299
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: longitudinal, randomized block RCT with repeated measures
Primary purpose: BASIC_SCIENCE

Brief summary: The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.

Detailed description: A randomized controlled trial will test a cognitive behavioral skills building intervention (COPE-P) in Black and Hispanic women experiencing emotional distress in two sites (New York and Ohio) to determine if the intervention leads to better health behaviors, better psychosocial health (anxiety, stress, and depressive symptoms), and improved birth and post-natal outcomes in women experiencing emotional distress. Developing scalable prenatal interventions designed to improve birth outcomes as well as maternal physical and psychosocial health is essential to decrease health disparities in pregnant minority women.

Eligibility criteria: Inclusion Criteria:

* Pregnant women between the ages of 18-40 years old
* Pregnant women experiencing an uncomplicated singleton pregnancy of less than 19 weeks
* Self-identified as either Black or Hispanic
* Able to read and speak English.
* The child participants born to the participants will have their record accessed for data collection.

Exclusion Criteria:

* Women with chronic medical conditions (e.g., hypertension, or diabetes), are currently receiving treatment or therapy for a psychiatric diagnosis, or have participated in this study with a prior pregnancy.
* Women with obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities.

Primary outcomes:
measure: Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3
timeFrame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
measure: Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3
timeFrame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
measure: Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3
timeFrame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
measure: Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3
timeFrame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
measure: Change Self-reported Stress at Timepoint 0 to Timepoint 3
timeFrame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Secondary outcomes:
measure: Birth Weight
timeFrame: T2= 6-8 week postpartum visit
measure: Breastfeeding Initiation
timeFrame: T2= 6-8 week postpartum visit
measure: Breastfeeding Duration
timeFrame: T3 = at 6 month well baby visit
measure: Mode of Delivery
timeFrame: T2= 6-8 week postpartum visit
measure: Nutritional Intake
timeFrame: Timepoint 0 (<19 weeks gestation), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
measure: Level of Exercise
timeFrame: T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
measure: Gestational Age at Birth
timeFrame: T2= 6-8 week postpartum visit
measure: Weight
timeFrame: Timepoint 0 (<19 weeks gestation)
measure: Participant Body Mass Index (BMI)
timeFrame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
measure: Participant Height
timeFrame: Timepoint 0 (Baseline at screening)
measure: Group Prenatal Care Acceptability
timeFrame: T1=31 gestational weeks
measure: Program Evaluation: Delivery Method
timeFrame: Timepoint 3, approximately 6 months postpartum
measure: COPE-P Acceptability
timeFrame: Timepoint 2 (6 to 8 weeks postpartum)
measure: Program Evaluation
timeFrame: Timepoint 3, approximately 6 months postpartum
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Columbus
country: United States
facility: OSU Total Health and Wellness
state: Ohio
city: Columbus
country: United States
facility: OSUWMC OB/GYN Clinic
state: Ohio
Study officials:
affiliation: Ohio State University
name: Bernadette Melnyk, PhD
role: PRINCIPAL_INVESTIGATOR
References: