Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

Depression Clinical Trial

— A-RCT  

Official title:

Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A-RCT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03416010
• Other study ID #: 2017B0425
• Secondary ID: 1R01MD012770-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: April 20, 2024

Study information

• Verified date: August 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 299
• Est. completion date: April 20, 2024
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Affective Symptoms
• Anxiety
• Depression
• Depression, Postpartum
• Depressive Disorder
• Emotional Disturbances
• Malnutrition
• Nutritional Deficiency
• Post-Partum Depression
• Pregnancy Late

Intervention

Behavioral:
• COPE-P
Session 1 ABCs (A=Antecedent or Activator event, B=Belief that follows the event, C=Consequence: how you feel and how you behave). Session 2 self-esteem and positive self-talk, including ways to build self-esteem and the group provides examples of how to change unhealthy habits into healthy ones. Session 3 stress/coping during pregnancy. Physical and emotional responses to stress are discussed along with healthy snacking and healthy ways to cope with typical stresses. Session 4 planning, goal setting and the 4-step problem solving process. Session 5 dealing with emotions in healthy ways through positive thinking and effective communication. Session 6 coping with stressful situations encountered during pregnancy while continuing to reinforce the thinking-feeling-behaving triangle.

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York
United States	OSU Total Health and Wellness	Columbus	Ohio
United States	OSUWMC OB/GYN Clinic	Columbus	Ohio

Sponsors (9)

Lead Sponsor	Collaborator
Ohio State University	Boston College, Drexel University, Jacobi Medical Center, National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH), New York University, University of Arizona, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs	Healthy Lifestyle Beliefs Scale survey will be administered at each of the in-person meetings. This scale taps beliefs about various facets of maintaining a healthy lifestyle. This 16-item is scored on a five point Likert-type scale that ranging from 1 strongly disagree to 5 strongly agree. The higher the score the higher the beliefs of maintaining a healthy lifestyle.	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Primary	Change is being assessed for an increase or decrease in self-reported Anxiety level	The Generalized Anxiety Scale (GAD-7) is a 7-item survey which measures anxiety will be administered at each of the in-person meetings. The GAD-7 is a 7-item, 4-point Likert-type scale ranging from (0) Not at all to (3). Scores range from 0 to 21, with higher scores indicating greater functional impairment related to the patient's experience of anxiety. A score greater than or equal to 10 indicates moderate and higher anxiety and will be used in this study,	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Primary	Change is being assessed for an increase or decrease in self-reported stress	The Perceived Stress Scale (PSS) is a scale measuring stress will be administered at each of the in-person meetings. This scale is a standardized measure of global stress designed to elicit the degree to which respondents find their lives unpredictable, uncontrollable, and overloading (three central components of stress). A score of 20 or greater is the high stress cut-off and will be used in this study.	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Primary	Change is being assessed for an Increase or decrease in self-reported healthy lifestyle behaviors	The Healthy Lifestyle Behaviors Scale survey will be administered at each of the in-person meetings. Participants respond to each of the 15 items (e.g., I exercised regularly; I talked about my worries) on a 5-point Likert-type scale that ranges from 1 strongly disagree to 5 strongly agree. The higher the score the higher the healthy lifestyle behaviors are practiced.	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Primary	Change is being assessed for an increase or decrease in self-reported depressive symptoms	The Edinburgh Postnatal Depression Scale (EPDS) is a scale measuring depressive symptoms will be administered at each of the in-person meetings. The Edinburgh Postnatal Depression Scale is a 10 item self-report perinatal depression questionnaire. The scale asks participants to describe how they have felt in the previous week. Unlike other depression screening tools, the EPDS excludes questions regarding somatic symptoms of pregnancy and has been found to be equivalent to a structured interview in determining prevalence of depression. Scores range from 0-30 with higher scores signifying higher severity of depressive symptoms. A cut-off score of 10 on the EPDS will be used in this study to indicate moderate depressive symptoms.	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Secondary	birth weight	record of birth weight as recorded in patient's medical file	T2= 6-8 week postpartum visit
Secondary	Mode of Delivery: C-section, forceps/vacuum, vaginal	record of mode of delivery as recorded in patient's medical file	T2= 6-8 week postpartum visit
Secondary	Breastfeeding initiation time	DPI Form: survey administered at meeting 3 and meeting 4	T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit
Secondary	breastfeeding duration	DPI Form: survey administered at meeting 3 and meeting 4	T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit
Secondary	Mode of Delivery	(C/S, Vaginal, Forceps/Vacuum)	T2= 6-8 week postpartum visit
Secondary	COPE-P Acceptability	Index (COPE-P group): Survey administered at meeting 2 and meeting 3	T1 = 31 gestational weeks, T2= 6-8 week postpartum visit
Secondary	Nutritional intake	24 Hour Nutrition Log/Food Processor: survey will be administered at each of the in-person meetings	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Secondary	Level of Exercise	Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings	T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Secondary	Gestational age at birth	Gestational age at birth will be collected as reported on patient's medical chart	T2= 6-8 week postpartum visit
Secondary	Participant weight	weight in pounds will be collected and reported at each of the in person meetings	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Secondary	Participant Body Mass Index (BMI)	derived calculation from weight and height values reported at each of the in person meetings	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Secondary	Participant height	height in feet and inches will be recorded at each of the in person meetings	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Secondary	Group Prenatal Care Acceptability	Survey addressing participant responses to prenatal care in a group setting	T1=31 gestational weeks
Secondary	Program Evaluation	Separate forms for intervention and attention control that address qualitative data regarding participant experience in study program as well as delivery method, virtually or in-person	T1=31 gestational weeks; T3=6 month well-baby visit