Joan E. Cowdery

Stroke Health and Risk Education (SHARE): Design, methods, and theoretical basis

BACKGROUND Stroke is a disease with tremendous individual, family, and societal impact across all race/ethnic groups. Mexican Americans, the largest subgroup of Hispanic Americans, are at even higher risk of stroke than European Americans. AIM To test the effectiveness of a culturally sensitive, church-based, multi-component, motivational enhancement intervention for Mexican Americans and European Americans in reducing stroke risk factors. METHODS Participants enroll in family or friendship pairs, from the same Catholic church in the Corpus Christi Texas area, and are encouraged to change diet and physical activity behaviors and provide support for behavior change to their partners. Churches are randomized to either the intervention or control group. Goal enrollment for each of the 10 participating churches is 40 participant pairs. The intervention consists of self-help materials (including a motivational short film, cookbook/healthy eating guide, physical activity guide with pedometer, and photonovella), five motivational interviewing calls, two tailored newsletters, parish health promotion activities and environmental changes, and a peer support workshop where participants learn to provide autonomy supportive counseling to their partner. SHAREs three primary outcomes are self-reported sodium intake, fruit and vegetable intake, and level of physical activity. Participants complete questionnaires and have measurements at baseline, six months, and twelve months. Persistence testing is performed at 18 months in the intervention group. The trial is registered with clinicaltrials.gov (NCT01378780).

A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial.

Background and Purpose— The Stroke Health and Risk Education Project was a cluster-randomized, faith-based, culturally sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. Methods— Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the 3 outcomes was significant at the 0.05/3 level. Results— Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53 years; 84% subjects were Hispanic/Latino; and 64% subjects were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day [95% confidence interval: 0.08, 0.42], P=0.002), a greater decrease in sodium intake (−123.17 mg/d [−194.76, −51.59], P=0.04), but no difference in change in moderate- or greater-intensity physical activity (−27 metabolic equivalent–minutes per week [−526, 471], P=0.56). Conclusions— This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary end point. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01378780.

Exergame Apps and Physical Activity: The Results of the ZOMBIE Trial.

Background: Although there are thousands of health and fitness smartphone apps currently available, little research exists regarding the effects of mobile app technology on physical activity behavior. Purpose: The purpose of this study was to test whether Exergame smartphone applications increase physical activity levels. Methods: This was a 12-week randomized, controlled, parallel group trial. The intervention consisted of the use of Exergame smartphone apps and motivational messaging. Validated instruments were used to measure physical activity, enjoyment, motivation, and competence. Results: Forty subjects were randomized and completed baseline assessments; 39 (97.5%) completed the 12-week follow-up. Median age was 32 years (interquartile range [IQR] = 25, 41.75); 85% were women. No differences between groups were identified in primary or secondary outcomes. Within group, physical activity decreased in the controls and autonomous motivation increased in the intervention group. Discussion: Exploratory findings were interesting regarding the use of Exergames to encourage physical activity. The intervention group showed less of a decline in activity, suggesting a possible attenuation of the observed seasonal fluctuation by the use of the Exergames. Translation to Health Education Practice Given their popularity, health educators should continue to explore the use of Exergame apps as a tool to facilitate physical activity.

A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors

Background and Purpose— The Stroke Health and Risk Education Project was a cluster-randomized, faith-based, culturally sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. Methods— Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the 3 outcomes was significant at the 0.05/3 level. Results— Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53 years; 84% subjects were Hispanic/Latino; and 64% subjects were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day [95% confidence interval: 0.08, 0.42], P=0.002), a greater decrease in sodium intake (−123.17 mg/d [−194.76, −51.59], P=0.04), but no difference in change in moderate- or greater-intensity physical activity (−27 metabolic equivalent–minutes per week [−526, 471], P=0.56). Conclusions— This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary end point. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01378780.

Adolescent knowledge and attitudes related to clinical trials.

Background or aims Poor enrollment plagues most clinical trials. Furthermore, despite mandates to improve minority representation in clinical trial participation, little progress has been made. We investigated the knowledge and attitudes of adolescents related to clinical trials and made race/ethnicity comparisons in an attempt to identify a possible educational intervention target. Methods Students aged 13–18 years in southeast Michigan were offered participation through a class at one high school or two academic summer enrichment programs that drew from multiple high schools (73% response). Questionnaires previously validated in adults were administered. Non-Hispanic whites were compared with minorities using Wilcoxon rank-sum tests. Results Of the 82 respondents, the median age was 16 years (interquartile range: 15–17 years); 22 (28%) were white, 41 (51%) were African American, 11 (14%) were multiracial, 2 (2%) were American Indian or Alaska Native, 1 (1%) was Asian, 3 (4%) were Native Hawaiian or other Pacific Islander, and 2 respondents did not report a race (but did report Hispanic ethnicity). Nine (12%) were Hispanic. Only 27 (33%) had ever heard of a clinical trial. On a scale from 1 (most receptive) to 5 (least receptive) for learning more about a clinical trial for a relevant medical condition, the median score was 2 (interquartile range: 1–3) and for participating in a clinical trial for a relevant medical condition was 2 (interquartile range: 2–3). Overall knowledge was poor, with a median of 46% (interquartile range: 23%−62%) of knowledge answers correct. Knowledge was reduced (p = 0.0006) and attitudes were more negative (p = 0.05) in minorities than non-Hispanic whites, while minorities also endorsed more substantial barriers to trial participation (p = 0.0002). Distrust was similar between minority students and non-Hispanic whites (p = 0.15), and self-efficacy was greater in non-Hispanic whites (p = 0.05). Conclusion Educational interventions directed toward adolescents that address knowledge, attitudes, and distrust in order to improve clinical trial awareness and receptivity overall are needed and may represent a tool to address disparities in minority enrollment in clinical trials.

Reach Out Churches: A Community-Based Participatory Research Pilot Trial to Assess the Feasibility of a Mobile Health Technology Intervention to Reduce Blood Pressure Among African Americans:

Innovative strategies are needed to reduce the hypertension epidemic among African Americans. Reach Out was a faith-collaborative, mobile health, randomized, pilot intervention trial of four mobile health components to reduce high blood pressure (BP) compared to usual care. It was designed and tested within a community-based participatory research framework among African Americans recruited and randomized from churches in Flint, Michigan. The purpose of this pilot study was to assess the feasibility of the Reach Out processes. Feasibility was assessed by willingness to consent (acceptance of randomization), proportion of weeks participants texted their BP readings (intervention use), number lost to follow-up (retention), and responses to postintervention surveys and focus groups (acceptance of intervention). Of the 425 church members who underwent BP screening, 94 enrolled in the study and 73 (78%) completed the 6-month outcome assessment. Median age was 58 years, and 79% were women. Participants responded with their BPs on an average of 13.7 (SD = 10.7) weeks out of 26 weeks that the BP prompts were sent. All participants reported satisfaction with the intervention. Reach Out, a faith-collaborative, mobile health intervention was feasible. Further study of the efficacy of the intervention and additional mobile health strategies should be considered.

A multicomponent behavioral intervention to reduce stroke risk factor behaviors: The SHARE Cluster-Randomized Controlled Trial

Background and Purpose— The Stroke Health and Risk Education Project was a cluster-randomized, faith-based, culturally sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. Methods— Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the 3 outcomes was significant at the 0.05/3 level. Results— Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53 years; 84% subjects were Hispanic/Latino; and 64% subjects were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day [95% confidence interval: 0.08, 0.42], P=0.002), a greater decrease in sodium intake (−123.17 mg/d [−194.76, −51.59], P=0.04), but no difference in change in moderate- or greater-intensity physical activity (−27 metabolic equivalent–minutes per week [−526, 471], P=0.56). Conclusions— This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary end point. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01378780.

Relationship of Self-Determination Theory Constructs and Physical Activity and Diet in a Mexican American Population in Nueces County, Texas

Due to disparities in stroke risk among U.S. Hispanics, the need for culturally tailored, theory based effective health behavior change interventions persists. The purpose of this study was to examine selfdetermination theory (SDT) constructs related to cardiovascular disease (CVD) risk factors in a predominantly Mexican American population. The Stroke Health and Risk Education (SHARE) project was a cluster-randomized, faith-based behavioral intervention trial that enrolled Mexican Americans (MAs) and non-Hispanic whites (NHWs) from Catholic Churches in Nueces County, Texas. Data regarding SDT constructs and dietary and physical activity behaviors were collected via computer-assisted interviews using standardized instruments at the baseline assessment. Of the 801 subjects who consented, 760 completed baseline interviews. After eliminating cases with missing data, 733 participants (617 MA and 116 NHW) were included in the analyses. Participants were predominantly Mexican American (84%) and female (64%), and had a median age of 53 years. There were no significant ethnic differences in any of the baseline SDT scale scores with the exception of higher autonomous motivation scores for exercise among MAs (7.00 vs. 6.67, p = 0.01). Demographic differences in mean SDT scale scores were identified for sex, age, and income. Perceived competence and autonomous motivation were both significant predictors of diet and physical activity behaviors. This study increases our understanding of SDT constructs relative to diet and physical activity in a large, predominantly Mexican American sample. The results indicate that SDT is an appropriate framework to address CVD behavioral risk factors in a predominantly Hispanic population.