Preventing Postpartum Depression: Exercise as Medicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Depression Symptoms
研究概览
简要总结
The purpose of this study is to test whether a web-based (eHealth) exercise intervention for new moms at increased risk for postpartum depression increases physical activity and decreases postpartum depression symptoms.
详细描述
Postpartum depression is a debilitating and costly condition that is associated with significant health consequences for mothers and children. Counseling for prevention of postpartum depression is currently recommended in women at high risk of postpartum depression; however, there is a shortage of mental health care providers. There is a need for effective interventions to prevent postpartum depression that can be easily integrated into health care systems, yet do not involve intense health care system resources. eHealth interventions are promising in this regard.
Strong evidence suggests physical activity can reduce depression risk. This study will assess the effectiveness of an eHealth exercise intervention tailored to postpartum mothers for increasing physical activity levels and improving depressive symptoms in women at increased risk of postpartum depression. This intervention addresses several identified barriers to physical activity in postpartum women. The study will randomize 200 women to receive an eHealth exercise intervention for postpartum women or usual postpartum care. Device-based physical activity and depressive symptoms will be measured at 3 and 6 months after randomization.
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 (Investigator)
盲法说明
The Investigators and programmers/analysts will be blinded to the intervention assignment. The participants, project manager and research assistant will not be masked.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •KPNC member between 2 and 6 months postpartum
- •Current PHQ-8 score between 10-20 and no current depression diagnosis
- •Delivered baby in KPNC
- •English-speaking
- •Own a smartphone, computer, or TV with internet access
- •Free of a heart condition and a physician recommending medically supervised physical activity
- •Body Mass Index (BMI) between 18.5 and 40 (kg/m2)
- •A baby weighing between 11-22 lbs
排除标准
- •Engaged in regular, moderate or vigorous physical activity >90 minutes or more per week
- •Pregnant or planning to become pregnant in the ensuing three months
- •A baby with chronic illness/disorder(s) that prevent participant from holding or lifting him/her
- •Chest pain during physical activity, or has had chest pain within the prior month
- •Taking medication for hypertension or a heart condition
- •Tendency to fall due to syncope or dizziness
- •Orthopedic problems that might be aggravated by physical activity
- •Has exercise-induced asthma
结局指标
主要结局
Depression Symptoms
时间窗: 3 months
Continuous measure of depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-8). PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.
Device-Measured Physical Activity
时间窗: 3 months
Actigraph-measured minutes of moderate/vigorous physical activity
次要结局
- Self-reported Physical Activity(6 months)
- Device-measured Physical Activity(6 months)
- Depressive Symptoms(6 months)