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

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ClinicalTrials.gov Identifier: NCT03416010
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
New York University
Jacobi Medical Center
Boston College
University of Arizona
Drexel University
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Bernadette Melnyk, Ohio State University

Tracking Information
First Submitted Date  ICMJE November 14, 2017
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE March 5, 2018
Estimated Primary Completion Date March 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
  • Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs [ Time Frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit ]
    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.
  • Change is being assessed for an increase or decrease in self-reported Anxiety level [ Time Frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit ]
    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,
  • Change is being assessed for an increase or decrease in self-reported stress [ Time Frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit ]
    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.
  • Change is being assessed for an Increase or decrease in self-reported healthy lifestyle behaviors [ Time Frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit ]
    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.
  • Change is being assessed for an increase or decrease in self-reported depressive symptoms [ Time Frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03416010 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
  • birth weight [ Time Frame: T2= 6-8 week postpartum visit ]
    record of birth weight as recorded in patient's medical file
  • Mode of Delivery: C-section, forceps/vacuum, vaginal [ Time Frame: T2= 6-8 week postpartum visit ]
    record of mode of delivery as recorded in patient's medical file
  • Breastfeeding initiation time [ Time Frame: T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit ]
    DPI Form: survey administered at meeting 3 and meeting 4
  • breastfeeding duration [ Time Frame: T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit ]
    DPI Form: survey administered at meeting 3 and meeting 4
  • Mode of Delivery [ Time Frame: T2= 6-8 week postpartum visit ]
    (C/S, Vaginal, Forceps/Vacuum)
  • COPE-P Acceptability [ Time Frame: T1 = 31 gestational weeks, T2= 6-8 week postpartum visit ]
    Index (COPE-P group): Survey administered at meeting 2 and meeting 3
  • Nutritional intake [ Time Frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit ]
    24 Hour Nutrition Log/Food Processor: survey will be administered at each of the in-person meetings
  • Level of Exercise [ Time Frame: T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit ]
    Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings
  • Gestational age at birth [ Time Frame: T2= 6-8 week postpartum visit ]
    Gestational age at birth will be collected as reported on patient's medical chart
  • Participant weight [ Time Frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit ]
    weight in pounds will be collected and reported at each of the in person meetings
  • Participant Body Mass Index (BMI) [ Time Frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit ]
    derived calculation from weight and height values reported at each of the in person meetings
  • Participant height [ Time Frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit ]
    height in feet and inches will be recorded at each of the in person meetings
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women
Official Title  ICMJE Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A-RCT
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 two sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic,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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
longitudinal, randomized block RCT with repeated measures
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Emotional Disturbances
  • Depression
  • Pregnancy Late
  • Post-Partum Depression
  • Anxiety
  • Nutritional Deficiency
Intervention  ICMJE 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.

Study Arms  ICMJE
  • No Intervention: Control
    In addition to standard prenatal care the PregnancyPlus attention control group for 6 weeks will receive 1.5 hours of ACOG-designed patient education pamphlets. Material will include prenatal and post-partum education.. Dr. Gennaro will conduct the training of the attention control group midwives. The same protocol for assessing fidelity for COPE-P also will be used for assessing fidelity to the attention control intervention
  • Active Comparator: Intervention
    In addition to standard prenatal care the COPE-P intervention group will also receive 1.5 hours each week for 6 weeks the cognitive-behavior skills building program driven by CBT as the theoretical framework by health care providers trained in COPE-P by Dr. Melnyk. The content of the COPE program is driven by the literature review, the theoretical framework, previous studies of COPE interventions with mothers of preterm infants and prior work with pregnant minority women by our team.
    Intervention: Behavioral: COPE-P
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date March 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women between the ages of 18-40 years old
  • Pregnant women in their first trimester with a singleton pregnancy
  • Pregnancy of less than 16 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnancy is only experienced by women so only women are included as study participants.
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jackie Hoying, PhD 6142924844 hoying.80@osu.edu
Contact: Bernadette Melnyk, PhD 6142924844 melnyk.15@osu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03416010
Other Study ID Numbers  ICMJE 2017B0425
1R01MD012770-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bernadette Melnyk, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • New York University
  • Jacobi Medical Center
  • Boston College
  • University of Arizona
  • Drexel University
  • National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Bernadette Melnyk, PhD Ohio State University
PRS Account Ohio State University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP