Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility of treatment measured by participation rates
研究概览
简要总结
The purpose of the Preconception and Pregnancy Obesity Treatment and Prevention Among Women with A History of Depression preliminary study is to provide a lifestyle intervention for women with a history of depression who are trying to conceive or are pregnant in order to prevent excessive pre-pregnancy weights, avoid excessive gestational weight gain, and to improve other markers of metabolic health. The treatment program consists of 10 private sessions with a trained clinician at no cost to participants.
详细描述
The investigators are evaluating a new lifestyle intervention to help women with a history of depression who are pregnant or trying to conceive to learn to exercise, eat well, and live a healthy lifestyle. They are interested in examining if this therapy-based program can positively impact eating and exercising habits and see if the treatment is enjoyable. All participants will receive this 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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of depression
- •Pregnant in first trimester or planning to become pregnant within next year
- •Ability to give informed consent
- •Age > or = 18 and < 45 years
- •Overweight or obese (Body mass index > 25 kg/m^2)
排除标准
- •Unwilling/unable to comply with study procedures
- •Endorsed item on the Physical Activity Readiness Questionnaire (PAR-Q)
- •Diagnosis of anorexia nervosa or bulimia nervosa in the past month
- •Diagnosis of substance dependence in the past month
- •Active suicidality (Montgomery Asberg Depression Rating Scale (MADRS) item 10 score > 4)
- •Exercising regularly (i.e., 5 days per week for 30 min)
- •Neurologic disorder or history of head trauma
- •Contraindications to exercise or diet interventions (e.g., co-morbid nutritional and metabolic diseases, physical injuries, contraindications to exercise for pregnant women)
结局指标
主要结局
Feasibility of treatment measured by participation rates
时间窗: 10 weeks
Participation rates measure attendance at weekly sessions.
Acceptability of treatment on Client Satisfaction Questionnaire (CSQ-8)
时间窗: 10 weeks
The CSQ-8 is a reliable and valid self-report measure of satisfaction with care and perceived quality and acceptability of treatment.
次要结局
- Weight loss(10 weeks)
- Exercise duration on the Exercise Questionnaire (EQ)(10 weeks)
- Depression severity on the Montgomery-Asberg Depression Rating Scale (MADRS)(10 weeks)
研究者
Louisa Grandin Sylvia
Director of Psychology
Massachusetts General Hospital