Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants Using Cannabis
研究概览
简要总结
This study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence.
详细描述
This study will recruit 20 women in an open trial who are high risk for prenatal cannabis use for a 12-week program of using a Fitbit activity tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18+
- •12-25 weeks gestation with a healthy singleton pregnancy
- •Medically cleared for moderate physical activity
- •Self-report of cannabis use at least once/week in the 3 months prior to the pregnancy desire to not engage in prenatal cannabis use
- •Elevated depression (EPDS>=7) or anxiety (GAD7>=5)
- •English-speaking
- •Owns a smartphone to enable use of the Fitbit app
- •Current physical activity does not meet health recommendations (150 min/week mod intensity activity)
- •Expresses interest in reducing or discontinuing cannabis use
排除标准
- •Current DSM-5 diagnosis of moderate/severe substance use disorder other than CUD or nicotine use disorder
- •Use of illicit substances in the last 3 months (other than cannabis)
- •Acute psychotic symptoms
- •Current or recent suicidality or homicidally
- •Current anorexia or bulimia
- •Cognitive impairment
- •Physical or medical problems that would not allow safe participation in moderate intensity PA (i.e., not medical cleared by Ob/Gyn)
- •Has a plan to relocate away from the area during study period
- •Recently started new mental health or substance use treatment within past 4 weeks.
研究组 & 干预措施
Intervention
In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
干预措施: LPA + Fitbit Intervention (Behavioral)
结局指标
主要结局
Number of Participants Using Cannabis
时间窗: from week 6 to the end of the intervention at week 12
Number of participants using cannabis at week 12, assessed via the Timeline Follow Back
Steps/Day
时间窗: Baseline to 12-week endpoint
objectively-measured via wearable device
International Physical Activity Questionnaire (IPAQ) Walked 10+ Continuous Min/Day
时间窗: Baseline to 12-week endpoint
Number who reported walking 4 or more days/week for 10 or more continuous minutes per day
次要结局
- Edinburgh Postnatal Depression Screen(past week, assessed at week 12 (end of intervention))
- Generalized Anxiety Disorder -7(past 2 weeks, assessed at week 12 (end of intervention))
- Client Satisfaction Questionnaire (CSQ-8)(Week 12 End of Treatment (EOT))