Strategies for Self-Management Around the Reproductive Transition: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of sessions attended among women enrolled in the study
研究概览
简要总结
The purpose of this study is to enable the investigator to conduct proof of concept work related to the feasibility, acceptability, initial efficacy and mechanisms of action (focusing on maternal and infant modifiable factors) for a novel self-management intervention for pregnant women.
详细描述
This proposed study aims to adapt intervention to address excessive gestational weight gain and psychosocial functioning among a socioeconomically and racially diverse sample of pregnant women .Additionally, data on behavioral mechanisms associated with self-regulatory capacity, such as impulsive control and the ability to delay rewards, that may be linked to self-regulation during pregnancy are needed to support future interventions.
In this study, the investigators will develop and adapt an intervention (Self-Management Around the Reproductive Transition; SMART) that addresses maternal weight, stress, and mood, and document the feasibility, acceptability and initial efficacy of the SMART intervention.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 14 years of age
- •Less than 16 weeks gestation
- •English speaking
- •Singleton pregnancy
- •Receiving care at Magee-Womens Hospital, Latterman family health or other UPMC practices that provide obstetric care
排除标准
- •Preexisting diabetes
- •Use of medications known to affect weight
- •Enrolled in current weight management programming
- •History of weight loss surgery
- •Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate care
结局指标
主要结局
Number of sessions attended among women enrolled in the study
时间窗: Approximately 9 months
Number of sessions attended will be calculated for each participant
Gestational weight gain
时间窗: Approximately 9 months
Gestational weight gain will be calculated for each participant. Weight in pounds will be measured on a calibrated scale while women are in street clothes without shoes.
Number of self-monitoring forms returned
时间窗: Approximately 9 months
Number of self-monitoring forms returned will be calculated for each participant
次要结局
- Depressive symptoms(Approximately 12 months)
- Perceived stress symptoms(Approximately 12 months)
研究者
Michele Levine
Associate Professor
University of Pittsburgh