Obesity Clinical Trial
Official title:
The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)
The overarching goal of our proposal is to reduce disparities in perinatal cardiovascular disease risk factors among Black women utilizing a community-driven, social ecological framework.
Status | Recruiting |
Enrollment | 432 |
Est. completion date | October 10, 2026 |
Est. primary completion date | July 10, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age =18 years - baseline BMI =30 kg/m2 and/or diagnosis of HTN (=130/80 x 2) - gestational age <24 weeks by last menstrual period - smartphone ownership - self-identification as Black or African American |
Country | Name | City | State |
---|---|---|---|
United States | Temple University/Temple Health | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in blood pressure at 6-weeks postpartum. | Blood pressure will be measured at each time point on the upper arm three times at one-minute intervals after five minutes of quiet sitting. The investigators will use the validated Omron HEM-907XL and the appropriate size cuff. The investigators will average the three measures for analysis. | At baseline and 6-weeks postpartum | |
Primary | Change in blood pressure at 12-months postpartum. | Blood pressure will be measured at each time point on the upper arm three times at one-minute intervals after five minutes of quiet sitting. The investigators will use the validated Omron HEM-907XL and the appropriate size cuff. The investigators will average the three measures for analysis. | At baseline and 12-months postpartum | |
Primary | Change in body weight at 6-weeks postpartum. | Body weight will be measured in duplicate and recorded to the nearest 0.1kg using calibrated SECA scales at each time point. | At baseline and 6-weeks postpartum | |
Primary | Change in body weight at 12-months postpartum. | Body weight will be measured in duplicate and recorded to the nearest 0.1kg using calibrated SECA scales at each time point. | At baseline and 12-months postpartum | |
Secondary | Change in emotional support at 6-weeks postpartum. | The investigators will use the 8-item emotional support PROMIS instrument to measure perceived feelings of being cared for at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater emotional support. | At baseline and 6-weeks postpartum | |
Secondary | Change in emotional support at 12-months postpartum. | The investigators will use the 8-item emotional support PROMIS instrument to measure perceived feelings of being cared for at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater emotional support. | At baseline and 12-months postpartum | |
Secondary | Change in informational support at 6-weeks postpartum. | The investigators will use the 8-item informational support PROMIS instruments to measure perceived availability of helpful information or advice at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater informational support. | At baseline and 6-weeks postpartum | |
Secondary | Change in informational support at 12-months postpartum. | The investigators will use the 8-item informational support PROMIS instruments to measure perceived availability of helpful information or advice at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater informational support. | At baseline and 12-months postpartum | |
Secondary | Change in Perinatal Mood and Anxiety Disorders (PMADs) at 6-weeks postpartum. | PMADs will be assessed using the Beck Depression Inventory II (BDI-II), a 21-item screening tool. The BDI-II has demonstrated concurrent validity with other postpartum depression scales and validated cut points for mild/moderate depressive symptoms in Black women of low-socioeconomic position. The lowest possible raw score is 1; the highest possible raw score is 40. Higher scores indicate greater depressive symptoms. | At baseline and 6-weeks postpartum | |
Secondary | Change in PMADs at 12-months postpartum. | PMADs will be assessed using the Beck Depression Inventory II (BDI-II), a 21-item screening tool. The BDI-II has demonstrated concurrent validity with other postpartum depression scales and validated cut points for mild/moderate depressive symptoms in Black women of low-socioeconomic position. The lowest possible raw score is 1; the highest possible raw score is 40. Higher scores indicate greater depressive symptoms. | At baseline and 12-months postpartum | |
Secondary | Mothers autonomy in decision making at baseline. | The 7-item Mothers Autonomy in Decision Making scale rates patients' level of agency and autonomy experienced during conversations with a maternity provider. The range of scores is 7-42, with higher scores indicating more opportunities to take an active role and lead decisions. | Baseline | |
Secondary | Mothers autonomy in decision making at 6-weeks postpartum. | The 7-item Mothers Autonomy in Decision Making scale rates patients' level of agency and autonomy experienced during conversations with a maternity provider. The range of scores is 7-42, with higher scores indicating more opportunities to take an active role and lead decisions. | 6-weeks postpartum | |
Secondary | Respectful maternity care at baseline. | Respectful maternity care will be assessed by the 14-item Mothers on Respect Index, which examines the nature of provider-patient relationships and access to person-centered care. The range of scores is 14-84, with higher scores indicating more respectful care.
lead decisions. |
Baseline | |
Secondary | Respectful maternity care at 6-weeks postpartum. | Respectful maternity care will be assessed by the 14-item Mothers on Respect Index, which examines the nature of provider-patient relationships and access to person-centered care. The range of scores is 14-84, with higher scores indicating more respectful care. | 6-weeks postpartum | |
Secondary | Obstetric mistreatment at baseline. | The 8-item Mistreatment Index queries patients' experience of dimensions of mistreatment (e.g., physical abuse, discrimination). To describe the overall prevalence of mistreatment, the investigators will calculate the proportion of women who experienced each of the seven types of mistreatment and what proportion experience any mistreatment (i.e. any of the seven indicators). | Baseline | |
Secondary | Obstetric mistreatment at 6-weeks postpartum | The 8-item Mistreatment Index queries patients' experience of dimensions of mistreatment (e.g., physical abuse, discrimination). To describe the overall prevalence of mistreatment, the investigators will calculate the proportion of women who experienced each of the seven types of mistreatment and what proportion experience any mistreatment (i.e. any of the seven indicators). | 6-weeks postpartum | |
Secondary | Blood pressure control at 6-weeks postpartum for patients with hypertension (HTN) at baseline. | Blood pressure control will be assessed at each time point for patients with HTN at enrollment (proportion with mean systolic BP = 130mm/Hg or mean diastolic BP = 80mm/Hg). | 6-weeks postpartum | |
Secondary | Blood pressure control at 12-months postpartum for patients with hypertension at baseline. | Blood pressure control will be assessed at each time point for patients with HTN at enrollment (proportion with mean systolic BP = 130mm/Hg or mean diastolic BP = 80mm/Hg). | 12-months postpartum | |
Secondary | Incident hypertension at 6-weeks postpartum for patients who were normotensive at baseline. | Data will be collected about incident HTN at 6-weeks and 1-year postpartum for normotensive patients at enrollment (proportion with mean systolic BP =130 mm/Hg or mean diastolic BP = 80mm/Hg). | 6-weeks postpartum | |
Secondary | Incident hypertension at 12-months postpartum for patients who were normotensive at baseline. | Data will be collected about incident HTN at 6-weeks and 1-year postpartum for normotensive patients at enrollment (proportion with mean systolic BP =130 mm/Hg or mean diastolic BP = 80mm/Hg). | 12-months postpartum | |
Secondary | Breast/Chestfeeding initiation. | Breast/chestfeeding initiation will be assessed via questions adapted from the Infant Feeding Practices Study II. | 6-weeks postpartum | |
Secondary | Breast/Chestfeeding duration. | Breast/chestfeeding duration will be assessed via questions adapted from the Infant Feeding Practices Study II. | 12-months postpartum | |
Secondary | Breastfeeding support/self-efficacy at 6-weeks postpartum. | Breast/chestfeeding self-efficacy will be assessed via questions adapted from the Breastfeeding Self-Efficacy Scale. The range of scores is 14-70, with higher scores indicating greater self-efficacy. | 6-weeks postpartum | |
Secondary | Breastfeeding support/self-efficacy at 12-months postpartum. | Breast/chestfeeding self-efficacy will be assessed via questions adapted from the Breastfeeding Self-Efficacy Scale. he range of scores is 14-70, with higher scores indicating greater self-efficacy. | 12-months postpartum | |
Secondary | Mode of delivery. | Mode of delivery will be abstracted from the electronic health record and categorized as either operative delivery (cesarean section) or non-operative (vaginal delivery), stratified by birth history. | 6-weeks postpartum | |
Secondary | Infant birth weight. | Infant birth weight will be abstracted from electronic health record. The investigators will calculate sex-specific birth weight for gestational age percentile based on national data. | 6-weeks postpartum | |
Secondary | Preterm birth. | To determine rates of preterm birth, gestational length will be calculated from last menstrual period (LMP) unless ultrasound dating differs =10 days from LMP dating. Pregnancy loss will be assessed by self-report, verified by electronic health record. | 6-weeks postpartum | |
Secondary | Blood pressure change at 32-34 weeks gestation. | Assessed through validated home blood pressure telemonitoring devices to reduce patient burden so to not miss shifts in BP from normotensive to hypertensive during critical periods of elevated CVD risk - shifts that would prompt more intensive monitoring and earlier treatment. | Baseline and 32-34 weeks gestation | |
Secondary | Blood pressure change at 1 week postpartum. | Assessed through validated home blood pressure telemonitoring devices to reduce patient burden so to not miss shifts in BP from normotensive to hypertensive during critical periods of elevated CVD risk - shifts that would prompt more intensive monitoring and earlier treatment. | Baseline and 1-week postpartum | |
Secondary | Blood pressure change at 12 weeks postpartum. | Assessed through validated home blood pressure telemonitoring devices to reduce patient burden so to not miss shifts in BP from normotensive to hypertensive during critical periods of elevated CVD risk - shifts that would prompt more intensive monitoring and earlier treatment. | Baseline and 12-weeks postpartum |
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