Multilevel Community Engagement to Inform a Randomized Clinical Trial.

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.

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 NCT01530776.

Preventing excessive gestational weight gain among African American women: A randomized clinical trial.

OBJECTIVE: Evidence is lacking regarding effective weight control treatments in pregnancy for ethnic minority women with obesity. This study evaluated whether a technology-based behavioral intervention could decrease the proportion of African American women with overweight or obesity who exceeded Institute of Medicine (IOM) guidelines for gestational weight gain. METHODS: We conducted a two-arm pilot randomized clinical trial. Participants were 66 socioeconomically disadvantaged African American pregnant women (12.5 ± 3.7 weeks' gestation; 36% overweight, 64% obesity) recruited from two outpatient obstetric practices at Temple University between 2013 and 2014. We randomized participants to usual care (n = 33) or a behavioral intervention (n = 33) that promoted weight control in pregnancy. The intervention included: (1) empirically supported behavior change goals; (2) interactive self-monitoring text messages; (3) biweekly health coach calls; and (4) skills training and support through Facebook. RESULTS: The intervention reduced the proportion of women who exceeded IOM guidelines compared to usual care (37% vs. 66%, P = 0.033). Intervention participants gained less weight during pregnancy (8.7 vs. 12.3 kg, adjusted mean difference: -3.1 kg, 95% CI: -6.2 to -0.1). No group differences in neonatal or obstetric outcomes were found. CONCLUSIONS: The intervention resulted in lower prevalence of excessive gestational weight gain.

Using technology to promote postpartum weight loss in urban, low-income mothers: a pilot randomized controlled trial.

OBJECTIVE: To examine the feasibility, acceptability, and initial efficacy of a technology-based weight loss intervention for urban, low-income mothers. METHODS: Eighteen obese, ethnic minority, socioeconomically disadvantaged mothers in the first year after childbirth were randomly assigned to either: 1) technology-based intervention, which included empirically supported behavior-change strategies, daily skills, and self-monitoring text messages with personalized feedback, biweekly counseling calls from a health coach, and access to a Facebook support group, or 2) usual-care control. RESULTS: After 14 weeks of treatment, the technology-based intervention participants had significantly greater weight loss (-2.9 ± 3.6 kg) than usual care (0.5 ± 2.3 kg; adjusted mean difference: -3.2 kg, 95% confidence interval -6.2 to -0.1 kg, P = .04). One-third of intervention participants (3 of 9) and no control participants lost > 5% of their initial body weight at follow up. CONCLUSIONS AND IMPLICATIONS: Results suggest the potential for using technology to deliver a postpartum weight loss intervention among low-income racial/ethnic minorities.