A Randomized Trial of Weight Change in a National Home Visiting Program.

INTRODUCTION: Clinical trials have demonstrated significant impact in reducing weight and incidence of type 2 diabetes mellitus. However, the intensity of these trials limits their scalability to real world settings. The purpose of this study was to embed a lifestyle intervention for overweight and obese mothers within the routine practice of a parent education, home visiting organization. DESIGN: Pragmatic trial that used a stratified random design. SETTING/PARTICIPANTS: Overweight or obese mothers of preschool children located across St. Louis, Missouri, enrolled in Parents As Teachers, a home visiting organization reaching women and children nationwide. INTERVENTION: A lifestyle intervention derived from the Diabetes Prevention Program was embedded within Parents As Teachers entitled Healthy Eating and Active Living Taught at Home (HEALTH). MAIN OUTCOME MEASURES: Outcomes included the proportion of women that achieved 5% weight loss at 24 months and improvements in clinical and behavioral outcomes at 12 and 24 months. Participants were enrolled from 2012 to 2014 and data analysis began in 2016. RESULTS: Women in the usual care versus intervention group were significantly less likely to achieve 5% weight loss at 24 months (11% vs 26%, p=0.01). At 12 months, there was a 2.8-kg difference in weight between groups (p=0.0006), and by 24 months a 4.7-kg difference in weight (3.2 [SD=7.6] kg vs -1.5 [SD=8.3] kg, p=0.002); group differences in waist circumference were also evident by 12 months (2.1 [SD=8.4] cm vs -0.7 [SD=9.8] cm, p=0.04) and 24 months (3.8 [SD=10.6] cm vs -2.5 [SD=9.1] cm, p=0.005), as were improvements in behavioral outcomes. There was no difference in blood pressure between groups. CONCLUSIONS: HEALTH achieved modest but clinically significant weight loss outcomes, and reduced weight gain in mothers of young children. The scalability of this embedded intervention offers the potential to reach mothers in Parents As Teachers programs nationally. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01567033.

Health Literacy INDEX: development, reliability, and validity of a new tool for evaluating the health literacy demands of health information materials.

There is no consensus on how best to assess the health literacy demands of health information materials. Comprehensive, reliable, and valid assessment tools are needed. The authors report on the development, refinement, and testing of Health Literacy INDEX, a new tool reflecting empirical evidence and best practices. INDEX is comprised of 63 indicators organized into 10 criteria: plain language, clear purpose, supporting graphics, user involvement, skill-based learning, audience appropriateness, user instruction, development details, evaluation methods, and strength of evidence. In a sample of 100 materials, intercoder agreement was high: 90% or better for 52% of indicators, and above 80% for nearly all others. Overall scores generated by INDEX were highly correlated with average ratings from 12 health literacy experts (r = 0.89, p < .0001). Additional research is warranted to examine the association between evaluation ratings generated by INDEX and individual understanding, behaviors, and improved health. Health Literacy INDEX is a comprehensive tool with evidence for reliability and validity that can be used to evaluate the health literacy demands of health information materials. Although improvement in health information materials is just one aspect of mitigating the effects of limited health literacy on health outcomes, it is an essential step toward a more health literate public.

Influenza vaccination concerns among older blacks: a randomized controlled trial.

CONTEXT: Vaccination can decrease the morbidity and mortality caused by influenza, yet vaccination rates remain low, especially among minority groups. Previous studies have found that important barriers to vaccination include the fear of adverse reactions and concern that the vaccine causes influenza. BACKGROUND: This research aimed to assess the effects of messages designed to address concerns about the safety and effectiveness of vaccination among blacks aged >or=50 years. DESIGN: In a randomized controlled trial conducted in 2007 with pre-exposure and post-exposure measurements, participants were randomly assigned to read either the vaccine safety messages (VSM) developed for the study (treatment condition) or the vaccine information statement (VIS) currently given to those getting the vaccine (control condition). SETTING/PARTICIPANTS: A total of 108 participants participated in the study. Data were collected in either participants' residences, community settings, or university conference rooms. MAIN OUTCOME MEASURES: Influenza vaccine-related beliefs and intention to receive vaccination were assessed. RESULTS: Data analysis in 2007 and 2008 found that the randomization hypotheses of equal groups were retained. Participants exposed to the VSM showed greater improvement in post-exposure beliefs about how the vaccine works (p=0.0006) and the transmission of the flu (p=0.0034) as well as greater post-exposure disagreement with the belief that the vaccine causes influenza (p=0.0411). CONCLUSIONS: The VSM affected beliefs about vaccine safety and effectiveness to a greater degree than did the VIS. These findings show that VSM are effective in changing beliefs empirically linked with influenza vaccination and vaccination disparities. The dissemination of VSM to older blacks may increase vaccination rates and reduce vaccination disparities.