Psychobiological Effects of Lifestyle Interventions in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change in Edinburgh Postpartum Depression Scale (EPDS) Score
研究概览
简要总结
This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation.
详细描述
Study Design This will be a randomized, parallel group, unblinded, single site superiority trial evaluating the impact of a physical activity intervention on reducing symptoms in people with known or screen-positivity for depression or anxiety during pregnancy. Participants will be randomized to a step count intervention versus usual care. Adherence will be monitored via Actigraph Link GT9X accelerometer watches.
Primary outcome: The primary outcome will be the mean within-person change in EPDS score between Time 2 (randomization) and Time 3 (37 weeks).
Secondary outcomes: Secondary outcomes will include additional psychobiologic measures, pregnancy complications, SMM events, and neonatal outcomes as shown below:
- Maternal Psychologic and Clinical: For psychologic measures, within person change in EPDS anxiety subscale score between Time 2 and Time 3, STAI score between Time 2 and Time 3, as well as within person change in both EPDS and STAI from Time 2 and Time 4 (6 weeks postpartum), will be assessed. Delivery outcomes (e.g. mode of delivery, gestational age at delivery) as well as complications including hypertensive disorders and SMM indicator events will be abstracted from the medical record.
- Maternal Biologic: For biologic measures, within person change in leukocyte telomere length and hair cortisol level from Time 2 and Time 3 will be assessed. Saliva samples for telomeres will be retained until the study is complete, at which point DNA will be extracted from leukocytes and telomere length will be measured using quantitative polymerase chain reaction. All correlated samples will be analyzed on the same 96-well plates. Telomere length results are reported as telomere "T" to single copy gene "S" standardized ratios which can be converted to base pairs using a standard equation. Within-person correlation of repeated continuous measures will be assessed using generalized estimated equations to evaluate longitudinal changes. Hair cortisol will be measured in two 3-inch hair sections, one at Time 2 and one at Time 3.
- Infant: Birthweight, Apgar scores, neonatal ICU admission, and length of stay will be evaluated.
Covariates: Demographic, clinical, and socioeconomic covariates of interest will be collected from participants. These variables will be ascertained via patient report (e.g. highest level of education, annual income, number of jobs worked, self-identified race and ethnicity, engagement in mental health treatments) and via chart abstraction (e.g. medical comorbidities, substance use, body mass index, neonatal birthweight and Apgar score). If covariates are unbalanced between groups, results from Aim 1 will be used to prioritize which covariates should be accounted for in adjusted models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Able to read and write in English or Spanish
- •Presenting for a prenatal visit with a viable singleton gestation (no known lethal fetal anomaly or plan for pregnancy termination) between 18 and 20 weeks 0 days
- •Any history of depression or anxiety, defined as: 1) documented depression or anxiety in the medical record within the preceding 2 years; 2) baseline EPDS score >=10 at intake prenatal visit; 3) baseline EPDS anxiety subscale 3A score >=5
排除标准
- •Known allergy to steel or rubber
- •Implantable medical device
- •Contraindication to physical activity such as a pre-existing cardiovascular condition or arrhythmia
- •Plan to relocate and/or deliver at another institution
- •Concurrent severe mental illness (diagnosis of bipolar disorder or schizophrenia)
- •Known lethal fetal anomaly or nonviable pregnancy
- •Baseline >30 min per week of vigorous physical activity (from Pregnancy Physical Activity Questionnaire, PPAQ)
研究组 & 干预措施
Usual step count
Participants will wear an Actigraph accelerometer watch, but not be given a step count goal, between 20 and 36 weeks of gestation.
干预措施: Actigraph watch (Device)
Step count goal
Participants will be given a daily step count goal of 8,000 steps per day based on the Actigraph watch, between 20 and 36 weeks of gestation. If they are not at goal, a step-up protocol will be designed for each participant and reviewed with a study team member every 2 weeks.
干预措施: Step count goal (Behavioral)
Step count goal
Participants will be given a daily step count goal of 8,000 steps per day based on the Actigraph watch, between 20 and 36 weeks of gestation. If they are not at goal, a step-up protocol will be designed for each participant and reviewed with a study team member every 2 weeks.
干预措施: Actigraph watch (Device)
结局指标
主要结局
Change in Edinburgh Postpartum Depression Scale (EPDS) Score
时间窗: Randomization around 20 weeks gestation and end of study (around 37 weeks gestation).
The mean within person change in EPDS score between randomization and the end of the study will be compared between the 2 arms. The EPDS is a 10-question validated measure with a score range of 0-30 for depression and/or anxiety screening in pregnancy that has been translated into many languages. A score of \>=10 has been shown to be consistent with depressive symptoms.
次要结局
- Change in EPDS Anxiety Subscale Score(Randomization around 20 weeks gestation and end of study (around 37 weeks))
- Change in State-Trait Anxiety Inventory (STAI) Score(Randomization around 20 weeks gestation and end of study (around 37 weeks))
- Change in leukocyte telomere length(Randomization around 20 weeks and end of study (around 37 weeks))
- Change in hair cortisol level(Randomization around 20 weeks and end of study (around 37 weeks))
- Frequency of pregnancy complications(6 weeks postpartum)
- Frequency of neonatal complications(6 weeks postpartum)
- Neonatal leukocyte telomere length(Day of life 1)
研究者
Danielle Panelli
Principal Investigator
Stanford University