Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A-RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 6
- 主要终点
- Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3
时间窗: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child 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 minimum score is 16 and the maximum score is 80. The higher the score the higher the beliefs of maintaining a healthy lifestyle.
Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3
时间窗: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child 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 in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3
时间窗: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child 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 minimum score is 15 and the maximum score is 75. The higher the score the higher the healthy lifestyle behaviors are practiced.
Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3
时间窗: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child 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.
Change Self-reported Stress at Timepoint 0 to Timepoint 3
时间窗: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child 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). The minimum score is 0 and the maximum score is 40. A higher score is correlated with a higher amount of stress. A score of 20 or greater is the high stress cut-off and will be used in this study.
次要结局
- Birth Weight(T2= 6-8 week postpartum visit)
- Breastfeeding Initiation(T2= 6-8 week postpartum visit)
- Breastfeeding Duration(T3 = at 6 month well baby visit)
- Mode of Delivery(T2= 6-8 week postpartum visit)
- Nutritional Intake(Timepoint 0 (<19 weeks gestation), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit)
- Level of Exercise(T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit)
- Gestational Age at Birth(T2= 6-8 week postpartum visit)
- Weight(Timepoint 0 (<19 weeks gestation))
- Participant Body Mass Index (BMI)(Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit)
- Participant Height(Timepoint 0 (Baseline at screening))
- Group Prenatal Care Acceptability(T1=31 gestational weeks)
- Program Evaluation: Delivery Method(Timepoint 3, approximately 6 months postpartum)
- COPE-P Acceptability(Timepoint 2 (6 to 8 weeks postpartum))
- Program Evaluation(Timepoint 3, approximately 6 months postpartum)
研究者
Bernadette Melnyk
Dean and Professor, College of Nursing Vice President of Health Promotion, Professor of Pediatrics and Psychiatry, College of Medicine
Ohio State University