4 research outputs found

    Multilevel Community Engagement to Inform a Randomized Clinical Trial

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    OBJECTIVE: To explore how patients, community-based perinatal support professionals, and health system clinicians and staff perceived facilitators and barriers to implementation of a randomized clinical trial (RCT) designed to optimize Black maternal heart health. METHODS: This article describes the formative work that we believed needed to occur before the start of the Change of H.E.A.R.T (Here for Equity, Advocacy, Reflection and Transformation) RCT. We used a qualitative, descriptive design and community-based, participatory approach, the latter of which allowed our team to intentionally focus on avoiding harm and equalizing power dynamics throughout the research process. Data were collected between November 2021 and January 2022 through six semistructured focus groups that included attending physicians and midwives (n=7), residents (n=4), nurses (n=6), support staff (n=7), community-based perinatal support professionals (n=6), and patients (n=8). RESULTS: Four primary themes emerged. The first three themes were present across all groups and included: 1) Trauma in the Community and Health System, 2) Lack of Trust, and 3) Desire to Be Heard and Valued. The fourth theme, Hope and Enthusiasm, was expressed predominantly by patients, community-based perinatal support professionals, residents, and support staff, and less so by the attending physician group. CONCLUSION: Participants articulated a number of key sentiments regarding facilitators and barriers to implementing Change of H.E.A.R.T. We noted variability in perceptions from different groups. This has important implications for health equity efforts in similarly underresourced health systems where Black birthing people experience the greatest morbidity and mortality. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT05499507

    Intervening during and after pregnancy to prevent weight retention among African American women

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    Efforts to prevent postpartum weight retention in extant clinical trials of African American women have proven exceedingly challenging. The primary purpose of this pilot study was to determine whether a behavioral intervention implemented in early pregnancy through 6 months postpartum could increase the proportion of African American women who were at or below their early pregnancy weights by 6 months postpartum. We additionally evaluated whether mothers' postpartum weight loss could be maintained at 12 months postpartum. Participants were 66 socioeconomically disadvantaged African American women (36% overweight, 64% obese) randomly assigned to a behavioral intervention or usual care group. The intervention, implemented from early pregnancy to 6 months postpartum, promoted weight control through: (1) empirically supported behavior change goals; (2) interactive self-monitoring text messages; (3) weekly to monthly health coach calls; and (4) skills training and support through Facebook. In modified intent-to-treat analyses, participants assigned to the intervention were significantly more likely to be at or below their early pregnancy weights by 6 months postpartum compared to usual care (56% vs. 29%, p = 0.04). At 12 months postpartum, the maternal weight difference between intervention and usual care groups was not maintained (41% vs. 38% respectively at or below early pregnancy weights, p = 0.83). Findings suggest that a combined pregnancy and postpartum weight control intervention improves 6 month weight outcomes in socioeconomically disadvantaged African American women with obesity. Longer interventions may be needed to overcome late postpartum weight gain among this high risk group. Clinical trial registration number: ClinicalTrials.gov identifier NCT0153077
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