Rationale and design of a pilot randomized controlled trial to increase moderate-to-vigorous physical activity in preadolescent Latina girls and their mothers.

Background: Hispanic/Latina girls have a low prevalence of moderate-intensity physical activity (PA) compared to their male counterparts and non-Hispanic White girls. Mothers influence their children's activity levels by creating and supporting PA opportunities, modeling PA, and reinforcing children's efforts to be physically active. The Conmigo trial will evaluate a mother-daughter intervention to promote PA and examine potential mechanisms of change including mothers' PA, parenting regarding PA, and mother-daughter communication. Method: This randomized controlled trial examines the feasibility, acceptability, and impact of a 12-week intervention promoting PA in preadolescent Latina girls in San Diego County, CA. Participants (n = 90 dyads) are randomized to the Conmigo PA intervention or to a control group that receive an abbreviated version of the intervention. The intervention was informed by Social Cognitive Theory and Family Systems Theory and emphasize family-level factors to promote PA using an actor-partner model. Mothers and daughters attend weekly 90-min sessions in English or in Spanish via Zoom video conferencing, supported by facilitator follow-ups and WhatsApp supportive chat group for mothers. Objective (accelerometer) and self-report measures at baseline, 3 months, and 6 months capture the frequency and intensity of PA and correlates and predictors of PA. We also examine the impact of the intervention on the bidirectional influence of mother-daughter PA. Implications: The findings from the Conmigo trial will form the basis of a randomized controlled community trial and will move the field forward in identifying targets of change in preventing chronic disease risk in Hispanic/Latino communities.

A Portfolio Analysis of Culturally Tailored Trials to Address Health and Healthcare Disparities.

In 2010, Patient-Centered Outcomes Research Institute (PCORI) was authorized by Congress to improve the quality and relevance of evidence available to help patients, caregivers, employers, insurers, and policy makers make better-informed health decisions. We conducted a qualitative analysis of behavioral health trials in the PCORI Addressing Disparities portfolio to examine cultural tailoring strategies across the following priority populations: racial and ethnic minorities, rural populations, people with low-income or low socioeconomic status, individuals with disabilities, people with low health literacy, and lesbian, gay, bisexual, and transgender (LGBT) communities. The Common Strategies for Enhancing Cultural Appropriateness model was used to examine cultural tailoring strategies within trials. We hypothesized increased intersectionality within a patient population at risk for disparities would correlate with the dosage and type of cultural tailoring strategies applied. Thirty-three behavioral health trials applied cultural tailoring strategies and a majority of trials (n = 30) used three or more strategies. Trends in cultural tailoring were associated with certain racial and ethnic groups; however, increased use of tailoring was not associated with the number of priority populations included in a trial. The PCORI Addressing Disparities portfolio demonstrates how a range of cultural tailoring strategies are used, within comparative clinical effectiveness research trials, to address the needs and intersectionality of patients to reduce health and healthcare disparities.