Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Postpartum weight loss at 6 months postpartum
研究概览
简要总结
Hypertensive disorders of pregnancy (HDP) are now well-recognized risk factors for adverse outcomes in the postpartum period and for development of future cardiovascular disease (CVD). Postpartum BMI has emerged as a strong predictor of both short- and long-term blood pressure (BP) control in observational studies suggesting that earlier postpartum lifestyle modifications may be instrumental in future CVD risk reduction in women with HDP. While such lifestyle modifications are recognized as critical for postpartum health, implementation and engagement of postpartum women remains a challenge as new mothers face greater barriers to in-person care given childcare responsibilities. The proposed study will investigate the acceptability of a virtual cardiac wellness program and its impact on weight, lifestyle modifications, cardiometabolic health, patient engagement, and outcomes following HDP as compared to the standard of care for postpartum women at Massachusetts General Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
In order to enable us to conduct a placebo-controlled study, we will not disclose to participants which intervention they have been assigned to. In order to obtain blinded data, incomplete disclosure is necessary to make the research scientifically valid and feasible. Unblinding subjects increases the risk that a favorable outcome is associated with the intervention simply because subjects are aware that they received an intervention and thus performing a placebo-controlled trial is necessary to determine the true effect of the intervention.
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
- •Women with a diagnosis of HDP inclusive of gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with superimposed preeclampsia
- •Pre-pregnancy BMI >18.5
- •Age ≥ 18 years
- •Access to a phone
- •Delivery at MGH and receive longitudinal obstetrics care at MGH
排除标准
- •Moderate or severe cognitive impairment
- •Current incarceration
- •Pre-pregnancy BMI ≤ 18.5
- •Women without a documented pre-natal weight or weight recorded 1 year prior to pregnancy
- •Baseline exercise of > 150 minutes/ week at the time of study enrollment
- •Not cleared for exercise by primary OB
结局指标
主要结局
Postpartum weight loss at 6 months postpartum
时间窗: 1 year
Postpartum weight loss (Last prenatal visit weight- weight at 6 months postpartum) as a proportion of weight gained during pregnancy (Last prenatal visit weight- either 1st prenatal weight or pre-pregnancy weight within 1 year)
次要结局
- Change in stress as assessed by self-reported stress survey(6 months)
- Change in self efficacy for physical activity assessed by questionnaire(6 months)
- Change in cardiovascular disease knowledge assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire(6 months)
- Postpartum weight loss at 1 year postpartum(1 year)
- Return to pre-pregnancy weight(1 year)
- Changes in blood pressure(1 year)
- Change in self efficacy for diet(6 months)
- Change in sedentary time(6 months)
- Change in physical activity as assessed by modified Duke Activity Status Index(6 months)
- Change in quality of diet assessed by Dietary Approaches to Stop Hypertension (DASH) score(6 months)
- Change in physical activity as assessed by self-reported physical activity survey(6 months)
- Change in stress as assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire(6 months)
研究者
Amy A. Sarma, MD
Cardiologist
Massachusetts General Hospital