A randomized clinical trial evaluating online interventions to improve fruit and vegetable consumption.

OBJECTIVES: We assessed change in fruit and vegetable intake in a population-based sample, comparing an online untailored program (arm 1) with a tailored behavioral intervention (arm 2) and with a tailored behavioral intervention plus motivational interviewing-based counseling via e-mail (arm 3). METHODS: We conducted a randomized controlled intervention trial, enrolling members aged 21 to 65 years from 5 health plans in Seattle, Washington; Denver, Colorado; Minneapolis, Minnesota; Detroit, Michigan; and Atlanta, Georgia. Participants reported fruit and vegetable intake at baseline and at 3, 6, and 12 months. We assessed mean change in fruit and vegetable servings per day at 12 months after baseline, using a validated self-report fruit and vegetable food frequency questionnaire. RESULTS: Of 2540 trial participants, 80% were followed up at 12 months. Overall baseline mean fruit and vegetable intake was 4.4 servings per day. Average servings increased by more than 2 servings across all study arms (P<.001), with the greatest increase (+2.8 servings) among participants of arm 3 (P=.05, compared with control). Overall program satisfaction was high. CONCLUSIONS: This online nutritional intervention was well received, convenient, easy to disseminate, and associated with sustained dietary change. Such programs have promise as population-based dietary interventions.

Body mass index measurement and obesity prevalence in ten U.S. health plans.

OBJECTIVE: The objective of this study was to examine the frequency of body mass index (BMI) measurement before the implementation of two new Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity that require U.S. health plans to annually report the frequency of BMI and BMI percentile measurement among all adults and children who had at least one outpatient visit during the past two years. DESIGN: Cross-sectional study. SETTING: A consortium of ten U.S. health plans and care delivery systems from the Health Maintenance Organization Research Network, which together provide care to more than 6.5 million adults and children. PARTICIPANTS: Children and adults, age 2 years and older, who were continuously enrolled in one of ten U.S. health plans for at least one full year from 2005 to 2006. METHODS: We extracted available anthropometric data for 3.7 million adults and 1.2 million children with at least one visit captured from ten electronic medical record databases from 2005 to 2006. RESULTS: We found that the availability of BMI measurements for adults ranged widely across health plans from 28% to 88%, and availability of BMI percentiles for children ranged from 21% to 81%. Among adults and children with BMI measures in these ten health plans, the overall prevalence of overweight and obesity were very similar to those reported in the 2005 to 2006 U.S. national surveys that used measured heights and weights. CONCLUSION: The newly approved HEDIS performance measures likely represent an important step in addressing the quality of obesity care in the United States. The current study demonstrates that these HEDIS measures are achievable, especially among health plans that have implemented electronic medical records. Future research should assess the relationship between BMI assessment, provider counseling and treatment practices, and long-term changes in obesity rates among different population groups.

A new audience segmentation tool for African Americans: the black identity classification scale.

Many health communications target African Americans in an attempt to remediate race-based health disparities. Such materials often assume that African Americans are culturally homogeneous; however, research indicates that African Americans are heterogeneous in their attitudes, behaviors, and beliefs. The Black Identity Classification Scale (BICS) was designed as a telephone-administered tool to segment African American audiences into 16 ethnic identity types. The BICS was pretested using focus groups, telephone pretests, and a pilot study (n = 306). The final scale then was administered to 625 Black adults participating in a dietary intervention study, where it generally demonstrated good internal consistency reliability. The construct validity of the BICS also was explored by comparing participants' responses to culturally associated survey items. The distribution of the 16 BICS identity types in the intervention study is presented, as well as select characteristics for participants with core identity components. Although additional research is warranted, these findings suggest that the BICS has good psychometric properties and may be an effective tool for identifying African American audience segments.

Media messages about cancer: what do people understand?

Health messages on television and other mass media have the potential to significantly influence the public's health-related knowledge and behaviors, but little is known about people's ability to comprehend such messages. To investigate whether people understood the spoken information in media messages about cancer prevention and screening, we recruited 44 adults from 3 sites to view 6 messages aired on television and the internet. Participants were asked to paraphrase main points and selected phrases. Qualitative analysis methods were used to identify what content was correctly and accurately recalled and paraphrased, and to describe misunderstandings and misconceptions. While most participants accurately recalled and paraphrased the gist of the messages used here, overgeneralization (e.g., believing preventative behaviors to be more protective than stated), loss of details (e.g., misremembering the recommended age for screening), and confusion or misunderstandings around specific concepts (e.g., interpreting "early stage" as the stage in one's life rather than cancer stage) were common. Variability in the public's ability to understand spoken media messages may limit the effectiveness of both pubic health campaigns and provider-patient communication. Additional research is needed to identify message characteristics that enhance understandability and improve comprehension of spoken media messages about cancer.

Engagement and retention: measuring breadth and depth of participant use of an online intervention.

BACKGROUND: The Internet provides us with tools (user metrics or paradata) to evaluate how users interact with online interventions. Analysis of these paradata can lead to design improvements. OBJECTIVE: The objective was to explore the qualities of online participant engagement in an online intervention. We analyzed the paradata in a randomized controlled trial of alternative versions of an online intervention designed to promote consumption of fruit and vegetables. METHODS: Volunteers were randomized to 1 of 3 study arms involving several online sessions. We created 2 indirect measures of breadth and depth to measure different dimensions and dynamics of program engagement based on factor analysis of paradata measures of Web pages visited and time spent online with the intervention materials. Multiple regression was used to assess influence of engagement on retention and change in dietary intake. RESULTS: Baseline surveys were completed by 2513 enrolled participants. Of these, 86.3% (n = 2168) completed the follow-up surveys at 3 months, 79.6% (n = 2027) at 6 months, and 79.4% (n = 1995) at 12 months. The 2 tailored intervention arms exhibited significantly more engagement than the untailored arm (P < .01). Breadth and depth measures of engagement were significantly associated with completion of follow-up surveys (odds ratios [OR] = 4.11 and 2.12, respectively, both P values < .001). The breadth measure of engagement was also significantly positively associated with a key study outcome, the mean increase in fruit and vegetable consumption (P < .001). CONCLUSIONS: By exploring participants' exposures to online interventions, paradata are valuable in explaining the effects of tailoring in increasing participant engagement in the intervention. Controlling for intervention arm, greater engagement is also associated with retention of participants and positive change in a key outcome of the intervention, dietary change. This paper demonstrates the utility of paradata capture and analysis for evaluating online health interventions. TRIAL REGISTRATION: NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5u8sSr0Ty).

Challenges in researching racially sensitive topics in HMOs.

When research designed to close the disparities gap is conducted in real-world health care settings, unique sensitivities may arise, particularly when race is the focus of interventions. Researchers encountered this issue in the course of a randomized trial investigating the influence of ethnic identity (EI) among African American (AA) study participants. The study was conducted by the research programs at three health maintenance organizations (HMOs) and the University of Michigan Center for Health Communications Research, as described in this issue of the journal (Resnicow et al., 2009). This commentary describes the research partnership's concerns for the racially sensitive nature of the study and the precautions undertaken to mitigate them. The research study's experiences may be informative and insightful for health plans and research centers invested in health disparities research.

Tailoring a fruit and vegetable intervention on ethnic identity: results of a randomized study.

OBJECTIVE: Many targeted interventions have been developed and tested with African Americans (AA); however, AAs are a highly heterogeneous group. One characteristic that varies across AAs is Ethnic Identity (EI). Little research has been conducted on how to incorporate EI into the design of health messages and programs. DESIGN: We tested whether tailoring a print-based fruit and vegetable (F & V) intervention on EI would enhance program impact. AA adults were recruited from two integrated healthcare delivery systems and then randomized to receive three newsletters focused on F & V behavior change over three months. One set of newsletters was tailored only on demographic and social cognitive variables (control condition), whereas the other (experimental condition) was additionally tailored on EI. MAIN OUTCOME MEASURES: The primary outcome for the study was F & V intake, assessed at baseline and three months later using the composite of two brief self-report frequency measures. RESULTS: A total of 560 eligible participants were enrolled, of which 468 provided complete 3-month follow-up data. The experimental group increased their daily mean F & V intake by 1.1 servings compared to .8 servings in the control group (p = .13). Afrocentric experimental group participants showed a 1.4 increase in F & V servings per day compared to a .43 servings per day increase among Afrocentric controls (p < .05). CONCLUSIONS: Although the overall between-group effects were not significant, tailoring dietary messages on ethnic identity may improve intervention impact for some AA subgroups.

Cost analyses of a web-based behavioral intervention to enhance fruit and vegetable consumption.

BACKGROUND: The purpose of this paper is to evaluate costs associated with the online intervention trial, Making Effective Nutritional Choices for Cancer Prevention (MENU), and to connect the findings to the study outcomes. METHODS: Using prospective data collected during the MENU development and implementation phases, we estimated overall costs per person, incremental costs for the three arms of the MENU intervention, and incremental costs per change in fruit and vegetable (F&V) consumption across the studied population. The MENU study was conducted in five HMO sites of the Cancer Research Network. The number of eligible study participants who were enrolled in the study was 2,540. Recruited participants were randomized into (1) an untailored website program, (2) tailored website program, or (3) tailored web program plus personalized counseling (HOBI) via email. The primary measures for these analyses include the total intervention costs, average cost per participant, and the average cost per mean change in daily intake of F&V, stratified by study arm. RESULTS: The mean change in F&V consumption was greater in both the tailored arm and statistically higher in the HOBI arm relative to the untailored arm. The untailored arm achieved +2.34 servings increase vs. the tailored website arm (+2.68) and the HOBI arm (+2.80) servings increase. Total intervention costs for MENU participants who completed the 12-month follow-up assessment, by study arm, were estimated to be $197,197 or $110 respectively. This translates to $69 per participant in the untailored web site intervention, $81 per participant in the tailored website intervention, and $184 per participant in the HOBI intervention and a cost per average change in F&V consumption to be $35, $27 and $61 respectively. CONCLUSIONS: Providing personalized "tailored" messages and additional personalized support via email generated an additional $12-$115 per participant, over the untailored web program. Incremental increases in F&V consumption associated with the email support arm were associated with considerable increases in intervention costs, suggesting that the most cost effective arm of the MENU study by servings gained was the tailored website.

Recruitment to a randomized web-based nutritional intervention trial: characteristics of participants compared to non-participants.

BACKGROUND: Web-based behavioral programs efficiently disseminate health information to a broad population, and online tailoring may increase their effectiveness. While the number of Internet-based behavioral interventions has grown in the last several years, additional information is needed to understand the characteristics of subjects who enroll in these interventions, relative to those subjects who are invited to enroll. OBJECTIVE: The aim of the study was to compare the characteristics of participants who enrolled in an online dietary intervention trial (MENU) with those who were invited but chose not to participate, in order to better understand how these groups differ. METHODS: The MENU trial was conducted among five health plans participating in the HMO Cancer Research Network in collaboration with the University of Michigan Center for Health Communication Research. Approximately 6000 health plan members per site, between the ages of 21 and 65, and stratified by gender with oversampling of minority populations, were randomly selected for recruitment and were mailed an invitation letter containing website information and a US$2 bill with the promise of US$20 for completing follow-up surveys. Administrative and area-based data using geocoding along with baseline survey data were used to compare invitees (HMO members sent the introductory letter), responders (those who entered a study ID on the website), and enrollees (those who completed the enrollment process). Generalized estimating equation multivariate and logistic regression models were used to assess predictors of response and enrollment. RESULTS: Of 28,460 members invited to participate, 4270 (15.0%) accessed the website. Of the eligible responders, 2540 (8.9%) completed the consent form and baseline survey and were enrolled and randomized. The odds of responding were 10% lower for every decade of increased age (P < .001), while the likelihood of enrolling was 10% higher for every decade increase in age (P < .001). Women were more likely to respond and to enroll (P < .001). Those living in a census tract associated with higher education levels were more likely to respond and enroll, as well as those residing in tracts with higher income (P < .001). With a 22% (n = 566) enrollment rate for African Americans and 8% (n = 192) for Hispanics, the enrolled sample was more racially and ethnically diverse than the background sampling frame. CONCLUSIONS: Relative to members invited to participate in the Internet-based intervention, those who enrolled were more likely to be older and live in census tracts associated with higher socioeconomic status. While oversampling of minority health plan members generated an enrolled sample that was more racially and ethnically diverse than the overall health plan population, additional research is needed to better understand methods that will expand the penetration of Internet interventions into more socioeconomically diverse populations. TRIAL REGISTRATION: Clinicaltrials.gov NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5jB50xSfU).

Tailoring a fruit and vegetable intervention on novel motivational constructs: results of a randomized study.

BACKGROUND: Tailored health communications to date have been based on a rather narrow set of theoretical constructs. PURPOSE: This study was designed to test whether tailoring a print-based fruit and vegetable (F & V) intervention on relatively novel constructs from self-determination theory (SDT) and motivational interviewing (MI) increases intervention impact, perceived relevance, and program satisfaction. The study also aimed to explore possible user characteristics that may moderate intervention response. METHODS: African American adults were recruited from two integrated health care delivery systems, one based in the Detroit Metro area and the other in the Atlanta Metro area, and then randomized to receive three tailored newsletters over 3 months. One set of newsletters was tailored only on demographic and social cognitive variables (control condition), whereas the other (experimental condition) was tailored on SDT and MI principles and strategies. The primary focus of the newsletters and the primary outcome for the study was fruit and vegetable intake assessed with two brief self-report measures. Preference for autonomy support was assessed at baseline with a single item: "In general, when it comes to my health I would rather an expert just tell me what I should do". Most between-group differences were examined using change scores. RESULTS: A total of 512 (31%) eligible participants, of 1,650 invited, were enrolled, of which 423 provided complete 3-month follow-up data. Considering the entire sample, there were no significant between-group differences in daily F & V intake at 3 month follow-up. Both groups showed similar increases of around one serving per day of F & V on the short form and half a serving per day on the long form. There were, however, significant interactions of intervention group with preference for autonomy-supportive communication as well as with age. Specifically, individuals in the experimental intervention who, at baseline, preferred an autonomy-supportive style of communication increased their F & V intake by 1.07 servings compared to 0.43 servings among controls. Among younger controls, there was a larger change in F & V intake, 0.59 servings, than their experimental group counterparts, 0.29 servings. Conversely, older experimental group participants showed a larger change in F & V, 1.09 servings, than older controls, 0.48. CONCLUSION: Our study confirms the importance of assessing individual differences as potential moderators of tailored health interventions. For those who prefer an autonomy-supportive style of communication, tailoring on values and other motivational constructs can enhance message impact and perceived relevance.

More than words: patients' views on apology and disclosure when things go wrong in cancer care.

OBJECTIVE: Guidelines on apology and disclosure after adverse events and errors have been in place for over 5 years. This study examines whether patients consider recommended responses to be appropriate and desirable, and whether clinicians' actions after adverse events are consistent with recommendations. METHODS: Patients who believed that something had gone wrong during their cancer care were identified. During in-depth interviews, patients described the event, clinicians' responses, and their reactions. RESULTS: 78 patients were interviewed. Patients' valued apology and expressions of remorse, empathy and caring, explanation, acknowledgement of responsibility, and efforts to prevent recurrences, but these key elements were often missing. For many patients, actions and evidence of clinician learning were most important. CONCLUSION: Patients' reports of apology and disclosure when they believe something has gone wrong in their care suggest that clinicians' responses continue to fall short of expectations. PRACTICE IMPLICATIONS: Clinicians preparing to talk with patients after an adverse event or medical error should be aware that patients expect their actions to be congruent with their words of apology and caring. Healthcare systems need to support clinicians throughout the disclosure process, and facilitate both system and individual learning to prevent recurrences.

Toward patient-centered cancer care: patient perceptions of problematic events, impact, and response.

PURPOSE: Cancer treatments are complex, involving multiple clinicians, toxic therapies, and uncertain outcomes. Consequently, patients are vulnerable when breakdowns in care occur. This study explored cancer patients' perceptions of preventable, harmful events; the impact of these events; and interactions with clinicians after such events. PATIENTS AND METHODS: In-depth telephone interviews were conducted with cancer patients from three clinical sites. Patients were eligible if they believed: something "went wrong" during their cancer care; the event could have been prevented; and the event caused, or could have caused, significant harm. Interviews focused on patients' perceptions of the event, its impact, and clinicians' responses to the event. RESULTS: Ninety-three of 416 patients queried believed something had gone wrong in their care that was preventable and caused or could have caused harm. Seventy-eight patients completed interviews. Of those interviewed, 28% described a problem with medical care, such as a delay in diagnosis or treatment; 47% described a communication problem, including problems with information exchange or manner; and 24% described problems with both medical care and communication. Perceived harms included physical and emotional harm, disruption of life, effect on family members, damaged physician-patient relationship, and financial expense. Few clinicians initiated discussion of the problematic events. Most patients did not formally report their concerns. CONCLUSION: Cancer patients who believe they experienced a preventable, harmful event during their cancer diagnosis or care often do not formally report their concerns. Systems are needed to encourage patients to report such events and to help physicians and health care systems respond effectively.

Health literacy and cancer prevention: two new instruments to assess comprehension.

OBJECTIVES: Ability to understand spoken health information is an important facet of health literacy, but to date, no instrument has been available to quantify patients' ability in this area. We sought to develop a test to assess comprehension of spoken health messages related to cancer prevention and screening to fill this gap, and a complementary test of comprehension of written health messages. METHODS: We used the Sentence Verification Technique to write items based on realistic health messages about cancer prevention and screening, including media messages, clinical encounters and clinical print materials. Items were reviewed, revised, and pre-tested. Adults aged 40-70 participated in a pilot administration in Georgia, Hawaii, and Massachusetts. RESULTS: The Cancer Message Literacy Test-Listening is self-administered via touchscreen laptop computer. No reading is required. It takes approximately 1 hour. The Cancer Message Literacy Test-Reading is self-administered on paper. It takes approximately 10min. CONCLUSIONS: These two new tests will allow researchers to assess comprehension of spoken health messages, to examine the relationship between listening and reading literacy, and to explore the impact of each form of literacy on health-related outcomes. PRACTICE IMPLICATIONS: Researchers and clinicians now have a means of measuring comprehension of spoken health information.

Ethnic Identity predicts loss-to-follow-up in a health promotion trial.

BACKGROUND: Higher rates of attrition in health research have been reported for African Americans (AAs). However, little is known about which AAs are more prone to drop out and why. One potential predictor that has not been explored is Ethnic Identity (EI). This study examined the association between EI and loss-to-follow-up among AAs enrolled in a health promotion intervention to increase fruit and vegetable intake. METHODS: Five hundred and sixty AA adults from two integrated health care delivery systems in Atlanta and Detroit were enrolled into a randomized intervention trial. At baseline, all participants were classified into six EI core groups: Afrocentric, Black American, Bicultural, Multicultural, Assimilated, and High Cultural Mistrust. We examined loss-to-follow-up rates by these EI type. RESULTS: Overall, 92 participants (16%) were lost to follow up. Loss-to-follow-up rates were higher among those classified as Afrocentric (24%) than those without an Afrocentric identity (13%). After adjustment for covariates, Afrocentric participants were 1.9 times (CI: 1.1-3.6) more likely to be lost to follow up than participants without this identity type. CONCLUSIONS: Assessing EI of AAs in research studies may help identify groups at risk for dropout and/or non-response.

Focus groups inform a web-based program to increase fruit and vegetable intake.

OBJECTIVE: To use focus groups to inform a web-based educational intervention for increased fruit and vegetable (FV) consumption. METHODS: Twelve groups (participants=137, aged 21-65) were recruited from four geographically diverse health systems. Four groups were stratified by gender and eight by race (white and African American) and gender. Questions included perceptions of healthy eating, factors that encourage or serve as barriers to FV consumption and features preferred for a web-based educational intervention. RESULTS: Though knowledgeable about healthy eating, participants did not know how to achieve or always care about healthy nutritional choices. Motivators for FV consumption included being role models and health concerns. Barriers included: lack of time, expense and FV availability. Website preferences included: visuals, links, tailored materials, menu suggestions, goal setting assistance, printable summaries and built in motivation. The developers incorporated nearly all suggestions. CONCLUSION: Focus groups provided needs-based tactical strategies for an online, education intervention targeting factors to improve FV consumption. PRACTICE IMPLICATIONS: Focus groups can provide valuable input to inform interventions. Further, web-based programs' abilities to offer information without time or geographic constraints, with capacity for tailoring and tracking progress makes them a valuable addition in the arsenal of efforts to promote healthy behaviors.