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临床试验/NCT02791932
NCT02791932已完成不适用

Exercise Intervention for Preventing Perinatal Depression

University of Minnesota2 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2017年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
2
主要终点
Edinburgh Postnatal Depression Scale

研究概览

简要总结

Fifteen percent of women experience depression during pregnancy or postpartum (i.e., perinatal depression). Furthermore, 38% of low income women experience postpartum depression. Given few women with perinatal depression seek treatment, there is a need for innovative, low cost interventions that can be integrated within existing community-based programs serving women in need (e.g., low income women). The primary aim of this study is to examine the efficacy of a novel exercise intervention designed to prevent perinatal depression among women attending federally qualified health centers serving high risk women.

详细描述

Approximately 15% of women experience perinatal depression (depression during pregnancy or postpartum). Furthermore, 38% of low income women experience postpartum depression (Gree-Smith et al., 2012). Perinatal depression is associated with numerous maternal (e.g., weight retention), infant (e.g., poor infant-child bond), and lifespan (e.g., behavior problems) consequences (Barker et al., 2011, Herring et al., 2008, Hipwell et al., 2000). Psychosocial interventions are efficacious for perinatal depression; however, only 10% of women seek treatment (Oppo et al., 2009). There is a need for innovative, low cost interventions that can be integrated within existing community-based programs serving women in need (e.g., low income women). Preliminary evidence indicates that exercise may be a novel, efficacious intervention. The primary aim of this study is to examine the efficacy of a novel exercise intervention designed to prevent perinatal depression among women attending federally qualified health centers serving high risk women. Possible effects on gestational weight gain and retention will also be explored. This study will build upon the study team's previous work by recruiting low income women and integrating the intervention with community-based clinics. Participants (n=200) who are low income and pregnant (less than 20 weeks) will be randomly assigned to either a telephone-based intervention that has been previously shown to increase exercise among perinatal women (Lewis et al., 2011) or usual care.

With regard to the primary aim, the investigators predict that participants randomized to the exercise intervention will report fewer depressive symptoms (as measured by Edinburgh Postnatal Depression Scale) at 36 weeks gestation and three months postpartum than women in the usual care condition. The secondary aim is to examine the efficacy of an exercise intervention on moderating prenatal weight gain and facilitating postpartum weight loss. The investigators will also examine several potential mediators (e.g., depression coping, self-efficacy, perceived stress, sleep, fatigue) and the effect of the exercise intervention on maternal (e.g., hypertension, gestational diabetes, mode of delivery) and infant outcomes (e.g., birth weight, gestational age at delivery, breastfeeding, safe sleep).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • less than 20 weeks pregnant
  • must speak English or Spanish
  • willing to be randomly assigned to either of the two study arms
  • healthcare provider consent
  • access to a telephone (92% of low income women have access to a telephone and Minnesota offers free phone access for low income individuals; Fasts, 2015)
  • being at risk for depression (defined as having a history of depression) but are not currently depressed.
  • consistent with prior research, history of depression will be defined as ever being told by a healthcare provider that she has depression and/or being prescribed an antidepressant for depression.

排除标准

  • less than 18 years of age
  • currently exercising 60 or more minutes per week
  • unable to exercise for 20 minutes continuously
  • history of heart disease, lung disease, anemia, musculoskeletal problems (e.g., arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising), poorly controlled hypertension, seizure disorder, exercise induced asthma, or any other medical condition that would make exercise unsafe
  • taking medication that interferes with heart rate responses to exercise such as beta blockers; participating in another exercise or weight management study
  • another member of the household participating in the study
  • currently receiving antidepressant medication or psychotherapy for depression; - hospitalization for a psychiatric disorder during previous six months
  • pregnant with multiple fetuses.
  • participants depressed at the baseline assessment will be referred to their healthcare provider.
  • there will have a safety protocol in place for worsening symptoms of depression and suicidal ideation

结局指标

主要结局

Edinburgh Postnatal Depression Scale

时间窗: Change from baseline to 3 months postpartum

次要结局

  • Postpartum Weight Retention(Change from baseline to 3 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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