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

高危少数族裔孕妇的健康生活方式干预：随机对照试验

• 批准号: 9921220
• 负责人: SUSAN GENNARO
• 金额: $ 72.55万
• 依托单位: BOSTON COLLEGE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-26 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9921220
• 关键词: Age; Anxiety; Behavior; Behavioral; Belief; Birth; Birth Weight; Body Weight decreased; Breast Feeding; Characteristics; Cognitive; Cognitive Therapy; Control Groups; Depression screen; Educational Background; Ethnic Origin; Evidence based intervention; Exercise; Gestational Age; Health; Health Promotion; Health behavior; Hispanics; Income; Intervention; Language; Link; Marital Status; Maternal Health; Mediating; Mental Depression; Mental Health; Minority; New York; Ohio; Outcome; Participant; Physical activity; Pilot Projects; Population; Postpartum Period; Pregnancy; Pregnancy Outcome; Pregnant Women; Prenatal care; Prevalence; Preventive care; Public Health; Race; Randomized Controlled Trials; Reporting; Research; Role; Site; Stress; Testing; Treatment Efficacy; Weight Gain; Woman; anxiety symptoms; attentional control; base; coping; depressive symptoms; design; efficacy testing; emotional distress; emotional experience; empowerment; evidence base; experience; health disparity; healthy lifestyle; high risk; high risk population; improved; innovation; lifestyle intervention; nutrition; parity; physical conditioning; post intervention; postpartum weight; pregnant; prenatal health; prenatal intervention; primary outcome; programs; psychological symptom; psychosocial; screening; secondary outcome; skills; stress symptom; theories; therapy design

Project Summary/Abstract 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. To meet the specific aims of this study we will: Specific Aim 1. Use a RCT to evaluate the short- and more long-term efficacy of the COPE-P program to improve healthy lifestyle behaviors (nutrition and exercise), psychosocial health, and birth and post-natal outcomes in pregnant emotionally distressed minority women as compared to an attention control group. Hypotheses 1a (primary outcomes). Immediately after the COPE-P program, at 4-6 weeks postpartum (3 months post intervention), and at 6 months postpartum (8 months post intervention), COPE-P participants will report higher healthy lifestyle behaviors, and less anxiety, stress and depressive symptoms than will the attention control participants. Hypothesis 1b (secondary outcomes). COPE-P participants will demonstrate more appropriate pregnancy weight gain, better birth outcomes (mode of delivery, birth weight, and gestational age), more appropriate postpartum weight loss, and better breastfeeding outcomes than attention control participants. Specific Aim 2. Examine the role of cognitive beliefs and perceived difficulty in leading a healthy lifestyle in mediating the effects of the COPE-P program on healthy lifestyle behaviors and psychological symptoms in minority pregnant women. Hypothesis 2 (theory building exploratory). The effects of the COPE-P program on participants' healthy lifestyle behaviors and levels of anxiety, stress and depressive symptoms will be mediated by beliefs about their ability to make healthy lifestyles choices and their perceived difficulty in leading a healthy lifestyle. Exploratory Aim. Explore characteristics that may moderate healthy lifestyle behaviors, psychosocial health, and birth and post-natal outcomes (e.g., race/ethnicity, income, age, parity, language, level of education, marital status). There is an urgent need to develop and evaluate theoretically-driven, culturally appropriate coping interventions that can be embedded in routine prenatal care and be widely scaled if found to be efficacious.

项目总结/摘要 本申请的总体目的是评估旨在减少 怀孕的、情绪紧张的少数民族妇女的健康差距。这项随机对照试验将测试 一个六个会议（间隔超过18周）认知行为技能建设（CBSB）产前护理干预 （专门设计，并根据先前的研究，为怀孕的少数民族妇女经历的情绪 在两个地点。为实现本研究的具体目标，我们将： 具体目标1。使用随机对照试验评价COPE-P项目的短期和长期疗效， 改善健康的生活方式行为（营养和锻炼）、心理社会健康以及分娩和产后 结果在怀孕的情绪困扰的少数民族妇女相比，注意力控制组。 假设1a（主要结局）。COPE-P计划后立即，产后4-6周 （干预后3个月）和产后6个月（干预后8个月），COPE-P参与者 将报告更健康的生活方式行为，更少的焦虑，压力和抑郁症状比将 注意力控制参与者 假设1b（次要结局）。COPE-P参与者将展示更合适的 怀孕体重增加、更好的分娩结局（分娩方式、出生体重和胎龄）等 适当的产后体重减轻，以及比注意力控制参与者更好的母乳喂养结果。 具体目标2。检查认知信念和感知困难在领导健康生活方式中的作用， 调解COPE-P计划对健康生活方式行为和心理症状的影响， 少数民族孕妇。 假设2（理论建设探索）。COPE-P计划对参与者健康的影响 生活方式行为和焦虑，压力和抑郁症状的水平将通过以下信念介导： 他们做出健康生活方式选择的能力以及他们在领导健康生活方式方面的感知困难。 探索目标。探索可能调节健康生活方式行为、心理健康、 以及出生和产后结果（例如，种族/族裔、收入、年龄、均等、语言、教育水平， 婚姻状况）。 迫切需要制定和评估理论驱动的、文化上适当的应对干预措施 可以嵌入到常规的产前护理中，如果发现有效，可以广泛推广。