Process evaluation of a clinical preventive nutrition intervention

Preventive

Medicine

33, 82-90

doi:l0.1006/pmed.2001.0863,

(2001)

available

online at http:Nwww.idealibrary.com

on

IIEkl@

Process Evaluation of a Clinical Preventive Nutrition Intervention’ Mary K. Hunt, M.P.H., R.D., FADA,” Rebecca Lobb, M.P.H.,? Helen K. Delichatsios, M.D., S.M.,$ Courtney Stone, M.P.H.,$ Karen Emmons, Ph.D.,*,2,3and Matthew W. Gillman, M.D., S.M.$ *Center for Community-Based Research, Dana-Farber Cancer Institute, 44 Binney Street, Boston, Massachusetts 02115; TDepartment of Ambulatory Care and Prevention, Harvard Pilgrim Health Care, 133 Brookline Avenue, Boston, Massachusetts 02215; and $Department of Ambulatory Care and Prevention, Harvard Medical School/Harvard Pilgrim Health Care, 133 Brookline Avenue, Boston, Massachusetts 02215

the relationship between diet and health and (2) tailored study recommendations. The inclusion of both parts of the diet-health endorsement, but not the length of time spent, appeared to correlate with healthful outcomes. Conclusions. These process data suggest that the brief PCP diet-health endorsement contributed to the intervention effect on fruits and vegetables. 0 2001 Amer.

Background. We report process data on the feasibility of delivering a clinical preventive nutrition intervention that was effective in increasing participants’ consumption of fruits and vegetables. We also examine relationships between process variables and study outcomes. Methods. We randomly assigned six practice sites in a managed care organization to a dietary intervention or control condition. We invited adults 18 years of age or older scheduled for routine health visits within the subsequent 2 months to participate. Of the 566 patients we contacted from the intervention sites, 230 (41%) enrolled. From the control sites, we contacted 617, and 274 (44%) enrolled. Intervention participants received a tailored letter providing feedback on their consump tion of target foods together with recommendations for improvement, stage-matched nutrition education booklets, a diet-health endorsement from their primary care providers (PCPs), and two motivational counseling telephone calls. Of enrollees, 195 (85%) in the intervention group and 252 (92%) in the control group returned the final survey 3 months later. Results. Seventy-one percent of both participants and PCPs reported that the PCPs had discussed the relationship between diet and health at their visit. Fifty-seven percent of participants and 62% of PCPs reported that they discussed the complete diet-health endorsement, which included: (1) acknowledgment of

ican Health Foundation

and Academic Press

Words: nutrition education; preventive nutrition; physician counseling; process evaluation. Key

INTRODUCTION

Adopting healthful eating behaviors can reduce morbidity and mortality from cancer and other chronic diseases 11-31. In addition to worksites, schools, and mass media, physicians’offices are important community settings for health promotion and disease prevention 141. Patients cite their physicians as reliable and credible sources of health information 15-81, and physicians agree that clinicians should provide dietary advice 19,101.However, only 20 to 50% of patients report that physicians discuss diet with them [11,12]. Brief motivational messages from physicians, with counseling from allied health professionals and a supportive office environment, reduce physician burden, make counseling more likely, and yield substantially increased rates of behavior change, compared with physician advice alone [JO,131. National guidelines recommend that physicians routinely advise their patients regarding behavioral risk factors for chronic disease [11,14,151. Several studies, however, have identified barriers physicians experience to providing nutrition counseling [7,16-181. Although physicians are well prepared in academic disciplines such as biochemistry and physiology, which form the

1The investigator team acknowledges Pew Charitable Trusts for financial support of this project through its Partnerships for Quality Education Program. 2 To whom reprint requests should be addressed at the Dana-Farber Cancer Institute and Harvard School of Public Health, 44 Binney Street, Boston, MA 02115. Fax: (617) 632-5690. E-mail: [email protected]. 3 Dr. Emmons is also affiliated with Harvard University, School of Public Health, Department of Health and Social Behavior, 677 Hintington Avenue, Boston, MA 02115 82

Copyright 0 2001 by American Health Foundation All rights of reproduction

0091-7435101 $35.00 and Academic Press in any form reserved.

EVALUATION

OF A NUTRITION

scientific basis of nutrition, they typically receive little training in translating nutrition science into food-focused dietary guidance U9-221 and in the skills needed to conduct behavior change counseling [16,23,24]. Another common barrier is lack of time [16-181. In addition, physicians report lack of high-quality nutrition education materials, inadequate reimbursement, and perceived patient noncompliance as barriers to nutrition counseling [9,16-18,21,251. The evolution of American medical care into a system that includes more managed care [26,271 requires new methods so physicians can provide advice regarding behavioral risk factors for chronic disease within the necessary time constraints. Managed care settings can both enhance and restrain disease prevention/health promotion efforts 128-301. For example, a managed care organization’s responsibility for a defined population provides a strong rationale for promoting health and preventing disease. The payoffs, however, are long term, and managed care organizations must be able to strike a balance between long-term outcomes and controlling short-term costs [211. The current study evaluated a nutrition intervention that addresses known barriers to preventive nutrition counseling (Table 1). The intervention synthesizes traditional clinical counseling with public health approaches to bring primary prevention to a patient population. In addition, this pilot study allows methods to be developed, tested, and refined prior to conducting a large population-based trial [311. The purposes of this paper are to report study process evaluation data and to examine associations between process variables and indicators of feasibility and study outcomes. These data provide a response to the call by health promotion program evaluators to report characteristics of interventions that make program effectiveness results more interpretable [32,331, help explain variability in results [331, and inform future efforts in similar areas 1321. METHODS

Study Design

EatSmart was a randomized, controlled pilot study designed to examine the feasibility and efficacy of an intervention in which patients’primary care providers (PCPs) provided a brief endorsement that consisted of: (1) an acknowledgement of the relationship between diet and health and (2) tailored study recommendations. PCPs were both primary care physicians and nurse practitioners. Telephone counselors provided motivational counseling support. The intervention targets were increased consumption of fruits and vegetables, decreased consumption of red and processed meats, and substitution of low-fat for whole-fat milk products. This

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83 TABLE 1

Strategies

Used in EatSmart

Providing Barrier Lack of time

Lack of food guidante knowledge

Lack of behavioral counseling knowledge and skills Lack of high-quality nutrition education materials Perceived patient noncompliance

Inadequate reimbursement

to Address Barriers to PCPs

Clinical Preventive

Nutrition

EatSmart

Interventions strategies

PCP gives only a brief diet-health endorsement. Health educators provide food guidance and motivational counseling by telephone. PCPs receive food guidance training. PCPs informed of patient’s tailored recommendations at the time of the visit. Health educators receive food guidance training. Health educators provide food guidance. Registered Dietitian provides consultation as needed. Trained student health educators provide motivational counseling. Educational materials and motivational counseling incorporate behavioral techniques such as stages of change. Study investigators design stage-matched educational materials specifically for the study. The intervention focuses on healthful eating, not weight loss. Personalized feedback letters and motivational counseling increase the likelihood of participant “buy-in.” Study not designed to address reimbursement.

study received approval from the Human Subjects Committee of Harvard Pilgrim Health Care. Setting

We conducted this study in six group practices affiliated with Harvard Pilgrim Health Care, a large managed care organization (MCO) in eastern Massachusetts. We paired the practices on the basis of number of physicians at each site. Within each pair we randomly assigned the practices to an intervention or a control condition. All health care providers at each site participated in the study, 28 providers in the intervention and 50 in the control sites. We identified patients through the practice site appointment systems. Eligible patients were those 18 years of age or older who had scheduled routine appointments with their primary care providers within the subsequent 2 months. We excluded pregnant women because some may have needed dietary modifications. We also excluded patients on gluten-free or renal-failure diets because specific dietary components included on a diet for generally healthy adults were contraindicated by their disease conditions. We excluded patients with cognitive impairments and those who did not speak English because they may have been unable to comprehend the intervention messages.

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HUNT ET AL.

Intervention

Participants in the control condition received a baseline survey with a follow-up mailing that included a report of their intake of fruits and vegetables, red and processed meat, and dairy products together with a Food Guide Pyramid brochure and a final survey with a tailored feedback letter. Participants in the intervention condition received: (1) a baseline survey with a follow-up mailing that included a tailored feedback letter and stage-matched educational brochures; (2) a brief in-person PCP diethealth endorsement supported by PCP training; (3) two motivational counseling telephone calls, supported by training of telephone counselors; (4) consultation with the study Registered Dietitian on an as-needed basis; and (5) a final survey with a tailored feedback letter. We describe components of the intervention below. Tailored feedback letters. We assessed patients’ dietary intakes prior to their PCP visit using an N-item food frequency questionnaire described below. We composed letters that summarized participants’ personal intake of fruits and vegetables, red and processed meat, and high-fat and low-fat milk products. We used SAS to generate recommendations tailored to the participant’s intake based on a predetermined algorithm that matched actual intake with study recommendations. These recommendations were to eat five or more servings of fruits and vegetables a day, three or fewer servings of red meat a week, and at least two servings of low-fat milk products each day along with two or fewer servings of whole-milk products a week. We mailed a letter with these recommendations to each participant as well as his/her PCP The letter served as a prompt to PCPs to give the diet-health endorsement and to reinforce participants’ tailored recommendations.

We created an algorithm for stages of readiness to change consumption of fruits and vegetables and saturated fat that used data from the baseline diet assessment as well as the Health Habits Survey 1341.Based on the transtheoretical stages of change model 135-381, we designed educational materials in booklet form that addressed fruit and vegetable and red and processed meat consumption that were appropriate for three stages, i.e., precontemplation/contemplation, preparation, or action/ maintenance. For example, precontemplatiomcontemplation materials addressed the pros and cons of the food recommendations. To the booklets for patients in preparation we added information on building skills to help establish regular healthful eating patterns. For patients in action/maintenance we added messages that would assist in maintaining established healthful eating patterns. Although dairy products also contribute to saturated fat intake, we did not include educational information on dairy foods because the short Stage-matched

educational

booklets.

length of the study period restricted the amount of information participants could assimilate and the number of behaviors they could change. We mailed these stagematched educational booklets to participants together with the tailored feedback letter. Brief primary care provider diet-health endorsement. We asked PCPs to give participants a two-part

diet-health endorsement. PCPs first acknowledged the relationship between diet and chronic disease prevention and, second, they reviewed the participant’s tailored feedback letter and encouraged them to work toward developing an eating pattern that incorporated the EatSmart recommendations. We provided several cues to increase the likelihood that providers would implement the endorsement. On the day of the scheduled visit, the medical assistants identified study participants from the appointment schedules, flagged their records, and placed the EatSmart recommendations in a prominent place in the medical record. In addition, we requested that participants bring a copy of their recommendations to the visit and initiate a discussion about nutrition with their providers. We asked PCPs to keep their messages brief and to tell participants that they would receive more information from the telephone counselors. Of the 28 clinicians who participated in the study, 19 attended a l-h orientation. These sessions offered the opportunity for PCPs to (1) learn the essential elements of the study; (2) understand their responsibilities; (3) complete PrimeScreen, the dietary assessment instrument; (4) participate in a role play with their colleagues on giving the endorsement; and (5) have a lunch that incorporated the EatSmart recommendations. We provided a video to the remaining nine clinicians to review prior to the start of the study. Motivational

Telephone Counseling

Motivational interviewing has been used effectively to enhance self-efficacy, increase recognition of inconsistencies between patients’ behavior and recommended health behaviors, teach skills for dissonance reduction through behavior change, and enhance motivation for change 1391.Primary components of motivational interviewing are de-emphasis on labeling, giving the patient responsibility for deciding if the behavior is problematic, encouraging participants to clarify and resolve ambivalence about behavior change, and setting goals as a means of initiating the change process. EatSmart telephone counselors had experience with patient contact prior to the training and were enrolled in Master’s level programs at the time of the study All telephone counselors attended two 4-h training workshops on the techniques of motivational interviewing, which were adapted for use in this intervention. Telephone counselors also attended one 2-h training on foods and nutrients related to the primary outcomes. In addition, the

EVALUATION

OF A NUTRITION

counselors met weekly with the project manager to review compliance with the protocol and use of motivational counseling techniques. The counselors called participants at 2 weeks and 2 months following the study visit to provide motivational counseling, chiefly for groups of foods participants chose to improve. In addition to consultation from a Registered Dietitian and study physician (M.W.G.), we provided health educators with several supports such as a library of nutrition textbooks and computer Web sites. Consultation

with‘ a Registered

Dietitian

A Registered Dietitian, who was an employee of the MCO, served as a resource when participants had dietary questions telephone counselors could not answer. The telephone counselors sent a referral form to the Registered Dietitian, who then called the participant. Data Collection,

Measures,

and Data Management

We mailed invitations to participate in the study together with baseline surveys to 566 patients in the intervention practice sites and 617 patients in the control sites. From the intervention sites, 230 (41%) patients returned completed surveys, and from the control sites, 274 (44%) patients completed and returned surveys, thus enrolling in the study Of enrollees, 195 (85%) in the intervention condition and 252 (92%) controls returned the final health habits survey 3 months later. To collect data from participants, we used two instruments, i.e., a Health Habits Survey, which included a short food frequency questionnaire called PrimeScreen, and surveys administered at the time of participants’ telephone interviews. For data collection from PCPs, we developed a provider survey The Health Habits Survey included an l&item food frequency questionnaire [401 derived from the longer versions of Willett and colleagues 1411.In their validation study, the authors report that for foods and food groups, the mean correlation coefficient was 0.70 for reproducibility and 0.61 for comparability with the 131-item semiquantitative food frequency questionnaire. Additional questions included on the Health Habits Survey were 3 items assessing stage of readiness to change [42], 2 items examining participants’ sources of nutrition information, 3 items assessing past experiences with provider nutrition counseling, 12 questions collecting sociodemographic information, and 4 questions assessing preferred timing of the telephone counseling calls. We sent a $5.00 gift to participants after completion of each survey. To estimate the extent to which PCPs typically address nutrition, we asked participants two questions at baseline, “During the past year, how many times did your current primary care provider discuss nutrition with you?” and “When your primary care provider discusses nutrition with you about how many minutes

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535

does he/she spend on the topic?” We asked the same questions in the final survey, using instead the past 3 months as the time period, to reflect the length of the intervention. Using questions from the annual Trends Survey of the American Dietetic Association 181 we asked patients on both the baseline and the followup surveys two questions about where they obtained nutrition information and which sources they found to be the most useful. To determine the most common sources of nutrition information, we asked participants to rank their top three responses to the question, “Where do you see or hear the most information on nutrition.” Possible responses were television, magazines, newspapers, radio, doctors, nurses, dietitians/ nutritionists, family/friends, food package labels, other. Because a large number of patients merely checked, but did not rank their responses, we recorded the proportion of patients who chose each possible response. To determine which sources of nutrition information were most useful, we asked participants, to rank each source as “not useful,” “somewhat, useful,” or “very useful.” Surveys administered to participants sion of the motivational counseling call.

at the conclu-

At the conclusion of each telephone interview, the counselors administered surveys to participants. Of the 230 patients we invited to participate in the two motivational counseling calls, 217 (94%) completed the first interview and survey and 183 (80%) completed the second interview and accompanying survey. At the end of the first telephone interview, we asked (1) “Did you see (provider’s name) as scheduled on (appointment date)?” At the end of both interviews, we asked (2) “Did (provider’s name) talk to you about nutrition at that visit?” (3) “Did (provider’s name) review the EatSmart recommendations with you during that visit?” (4) “Did (provider’s name) review your fruit and vegetable intake with you?” (5) “Did (provider’s name) review your red and processed meat intake with you?” (6) “About how many minutes did (provider’s name) spend talking with you about nutrition?” Primary care provider survey. We administered a 6item survey to 28 PCPs at the end of the intervention period. Twenty-one PCPs returned surveys for a response rate of 75%.. We used responses to the following questions on the PCP survey as estimates of the extent of the implementation of the endorsement: “How often did you talk with study participants during their visits about the benefits of healthy eating?” and “When you did provide nutrition information to study participants, how often did you consider the EatSmart recommendations?” The response categories for these two questions were “never,” “some of the time,” “often,” “always,” and “do not remember.” To obtain an estimate of t,he time it took to

86

HUNT ET AL.

deliver the endorsement, we asked, “For those patients with whom you had nutrition discussions, on average, how many minutes did those discussions take?” We used the following questions to elicit provider attitudes toward the intervention: “To what extent did the EatSmart recommendations make it easier to discuss the benefits of healthy eating with study participants?” with response categories “not at all,” “a little,” “moderately,” “a lot,” and “do not remember” and “Would you support implementing a nutrition program like EatSmart at your practice?” with response categories “yes, ” “no,” and “maybe.”

Indicators of Feasibility Intervention

of Implementing

the

At baseline, 50% of patients in the intervention group and 53% in the control group reported that they had had at least one nutrition discussion with their provider in the year prior to the study. Forty-eight percent of the patients in the Intervention and 59% of patients in the Control group estimated that these discussions lasted 5 min or less. The average number of ambulatory visits in the year prior to the study was 2.8 in the Intervention group and 2.5 in the Control. In the Intervention group 23% (62/274) of participants did not have Data management for tailored feedback letters. A an ambulatory visit in the year prior to the study and 30% (69/230) in the Control. research assistant performed all data management Seventy-one percent (154/217) of participants in the functions weekly, including data entry and report procintervention group reported that they discussed either essing for the stage-matched nutrition materials, using the diet-health relationship or the tailored recommenMicrosoft Office applications and SAS, a statistical dations with their providers at the study visits and 57% analysis software. The data were entered into an MS (124/217) reported that they discussed the complete ACCESS database and then converted to a SAS file. A diet-health endorsement, which included the relationSAS program, written by the study analyst, ran through ship between diet and health and the tailored recoman algorithm of decision points to determine patients’ mendations. The median length of the nutrition discusdietary intake, personal recommendations, and stage sion, as reported by participants, was 5 min (range of readiness to change based on questions related to l-30). diet and health habits. The results of the SAS program Seventy-one percent (15/21) of the providers reported were returned to MS ACCESS and the personalized acknowledging the diet-health, relationship often or alfeedback letters printed in MS WORD. These functions ways while 62% (13/21) said they gave the EatSmart required a median of 10 min per participant. recommendations often or always. PCPs reported that, on average, the median length of the endorsement was Data Analysis 3 min (range l-7.5). The difference in ranges in time reported by participants and providers may be due to We performed statistical analyses using SAS soft- the way in which the questions were asked. Particiware version 6.12 for Windows [43]. We measured pants were asked to report a time for the specific visit changes in food and nutrient outcomes from baseline and providers were asked to report an average time for to follow-up (3 months) based on the PrimeScreen 1341, all visits. A majority of providers (12/21) stated that and we examined associations between selected process they found the EatSmart recommendations made it easvariables and outcomes. We used mixed model analysis ier to deliver the nutrition endorsement. Eighty-one of covariance to adjust for age, sex, race, and baseline percent of providers stated that they would or might intake. Since the unit of randomization was the practice support providing EatSmart recommendations in their site, we also adjusted for the random effect of site nested practices (Table 2). in the intervention group. We performed an intentionto-treat analysis that assumed that intake at follow-up Associations of Process Variables to Outcomes was the same as intake at baseline among nonresponWe examined possible associations between process dents to the follow-up survey. variables and outcomes for fruit and vegetable and red and processed meat consumption. The baseline mean RESULTS daily servings of fruits and vegetables was 2.9 in the intervention group and 3.3 in the control group. At the 3-month follow-up, mean intakes were 4.0 and 3.7 servStudy Group Characteristics ings per day, respectively. Adjusting for age, sex, race, Participants were generally older adults (Interven- and baseline intake of fruits and vegetables, the estition, mean 50 years; Control, mean 57 years), female mated difference between groups in change in mean (Intervention, 77%; Control, 63%), well educated (Inter- daily servings of fruits and vegetables was 0.6 (95% CI vention, 62% Bachelor’s degree or more; Control, 57% 0.3,O.N We found no overall intervention effect for red Bachelor’s degree or more), and non-Hispanic white and processed meats [adjusted regression estimate 0.0 (Intervention, 83%; Control, 97%). servings per week (95% CI -0.3, 0.311[341.

EVALUATION

OF A NUTRITION

87

INTERVENTION

TABLE 2 Primary Care Provider (PCP) Participant,

and Reports of PCP Implementation

of Diet-Health

Endorsement

Participant (n = 217) Implementation

of diet-health

N

endorsement

Acknowledged diet-health relationship or discussed tailored recommendations Acknowledged diet-health relationship and discussed tailored recommendations EatSmart recommendations made the endorsement easier A lot Moderately A little Not at all I would support implementing EatSmart in my practice Yes Maybe No Duration of diet-health endorsement” [median number of minutes (range)] “Missing

data for 4% of participants;

154” 124

5

PCP 112= 21) (%,

N

(%i -

(71) (57)

15 13

(71) (62)

4 8 7 2

(19) (38) (33) 110)

11 6 3 3

1521 (291 (141 (1-7.5)

(l-30)

n = 154.

Table 3 shows relationships between the extent of intervention implementation and the magnitude of outcomes among intervention participants. For both fruits and vegetables and red and processed meat, the biggest effects appear to have occurred in the 54% (124/217) of participants who received both the acknowledgment of

the relationship between diet and health endorsement and reinforcement of the participant’s tailored recommendations from the PCP (Table 3). Among participants receiving a PCP endorsement, the length of the discussion was not clearly related to change in dietary behavior. In contrast, the length of the motivational

TABLE 3 Relationships

between Extent of Intervention Implementation and Change in Consumption Red and Processed Meat among Intervention Participants

Change in fruit and vegetable consumption (servings per day)”

Extent of intervention implementation (N : 230) No PCP visit PCP visit only PCP visit + acknowledgment PCP visit + acknowledgment recommendation P for trend

of Fruits and Vegetables

and

Change in red and processed meat consumption (servings per week)”

(%I

Mean

(SD)

Mean

SD

21 55 30

(9%) (24%) (13%)

1.08 0.97 0.96

(0.1, 2.1) (0.4, 1.6) (0.3, 1.7)

0.23 --0.08 -0.50

( 0.7, 0.5 / (-. 1.3, 0.3 I

124

(54%)

1.32

(0.9, 1.7)

-0.41

N

(-0.8,

1.21

+ 0.51

( --0.9, 0.01 0.06

Time (% of participants) Length of PCP endorsement

(n = 154)

(34%) (31%) (31%)

1.34 1.18 1.25

P for trend Length of first counseling

1-3 min 4-6 min >7 min -

call (n = 217)

1-5 min 6-10 min >ll min -

(3%) (45%) (53%)

0.55 1.11 1.30

1-5 min 6-10 min >ll min -

(20%) (55%) (25%)

0.76 1.03 1.22

P for trend Length of second counseling

P for trend “Adjusted

call (n = 183)

for age, sex, race, and baseline food intake.

(0.7, 2.0) (0.5, 1.8) (0.6, 1.9)

-0.36 0.73 -0.38

(-1.7, 2.8) (0.7, 1.6) (0.9, 1.8)

0.07 -0.13 ~-0.45

(0.2, 1.4) (0.6, 1.5) (0.7, 1.8)

-0.31 0.17 0.83

0.80

0.18

0.19

0.29

( --0.9, 0.2 1 c-1.3, -0.1) ( ~~1.0, 0.2 I (-2.3, 2.4: C---0.6, 0.41 ( ~-0.9, 0.0 1 0.05 i- 1.0, 0.41 (FO.6, 0.31 (- 1.4. -0.3) 0.24

HUNT -l!Al

88

counseling interviews appeared to be directly related to beneficial dietary changes, both for fruits and vegetables and for red and processed meat (Table 3). Surveys at the End of the Motivational Telephone Calls

Counseling

Participants reported spending a median of 15 min (range 3-30) with telephone counselors on the first telephone interviews and a median of 10 min (range 2-35) on the second interview. At the end of the second motivational counseling telephone call, 33% of patients reported that they were quite or extremely satisfied with their discussions with PCPs and 72% reported that they were quite or extremely satisfied with the discussions with the telephone counselors. The telephone counselors found that 89% of participants reported setting goals and 57% reported that they had reached their first goal. When asked to report up to two groups of food that were emphasized during the telephone counseling, 74% of participants reported that fruit and vegetable consumption was emphasized while 16% reported the primary focus as red and processed meats, 16% as low-fat dairy products, and 10% as whole-fat dairy products. Participants' Reports of Sources of Nutrition Information At the end of the intervention, participants in both groups reported their top three sources of nutrition information as television, magazines, and newspapers and their most valuable sources of information as doctors, dietitians, and nurses. Referrals

to the Registered

Dietitian

Health educators referred to the Registered Dietitian.

7 of the 230 participants

DISCUSSION

EatSmart innovations included conceptualizing the brief PCP intervention as a diet-health endorsement rather than a counseling session, designing the intervention with components specifically targeted to barriers that have been identified in the literature, training telephone counselors in the techniques of motivational interviewing, and designing and using educational booklets matched to participants’ stage of readiness to change eating behaviors. Process evaluation results of the EatSmart intervention showed a trend toward an association between the extent of intervention implementation and the outcomes. Delivery of both elements of the endorsement, but not the length of time, appeared to correlate with healthful outcomes. The adjusted effect estimates suggest a “dose-response” effect of including both elements

AL. ”

of the endorsement for red and processed meat but less so for fruits and vegetables. Small stratum-specific samples, however, limit precision of the estimates. There appears to be an association between the length of the motivational counseling interviews and beneficial dietary changes. However, these results may be confounded by the tendency for those more motivated to change to be more interested and, therefore, this may have been the reason for their longer interviews. Coupled with the overall beneficial effect of EatSmart on fruit and vegetable consumption, these data suggest that the EatSmart intervention is one effective response to the call by national health organizations for the development and delivery of population-based preventive services in clinical practice [11,15,44-461 and for the need for evidence that brief counseling strategies can have an impact on patient outcomes 111,471. The lack of change in consumption of red and processed meats and substitution of low-fat for high-fat milk products might be explained by the fact that almost three-fourths of the participants chose to set goals focused on increasing their fruit and vegetable consumption, while only 16% chose to set goals related to red and processed meats. This disparity may be explained by the relative simplicity of purchasing and preparation skills needed to change consumption of fruits and vegetables compared with red and processed meat and to the fact that there is a heightened public awareness of the health benefits of increased consumption of fruits and vegetables 148,491. Other investigators have reported feasibility and efficacy results from nutrition intervention studies in primary care settings with patients who were identified as having chronic disease or being at high risk 116,17,20,50-531. Patients with chronic disease were more highly motivated to change their behavior than patients without chronic disease [12,521. It is encouraging, therefore, that EatSmart had an impact on behavior of generally healthy adults. While about one-half of the PCPs said they would support implementing Eat Smart in their practices, the other one-half either were undecided or reported they would not do so. In preparation for a larger trial to test the EatSmart intervention we would conduct in-depth interviews with pilot-study providers to determine specific ways in which PCP participation could be enhanced. In the field of smoking cessation, investigators have found that there is a strong dose-response relationship between interpersonal contact, whether by physician or nonphysician, and favorable health behavior change 1541. Interpersonal contact among those EatSmart participants who received both parts of the diet-health

EVALUATION

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endorsement and the high level of participant satisfaction with the motivational interviews may have contributed to favorable reported outcomes in fruit and vegetable consumption. Social desirability bias, the participant’s desire to please the researcher, may also have played a role. EatSmart results support an assumption upon which this study is based, i.e., that health professionals are credible and reliable sources of nutrition information [Sl. At the time of the final survey, a mean of 47% of intervention participants and 40% of control participants reported doctors, dietitians, and nurses as their most useful sources of nutrition information. EatSmart was a pilot study; thus, the restricted sample size reduces confidence in the findings. In addition, the limited number of racial/ethnic minorities may limit generalizability. Both for dietary intake and for participant and PCP reports related to the delivery of the nutrition endorsement we used self-report measures. Although this is accepted practice in intervention trials, it does introduce the possibility of response bias. We were able to demonstrate that a large percentage of PCPs were willing and able to deliver the endorsement and that this could be done in a relatively brief period of time; however, the evidence for feasibility of this intervention is limited by lack of a formal cost-effectiveness component. This study, however, used a randomized, controlled design, employed a theory-based intervention, recruited and retained a high proportion of study participants, and had an impact on outcomes. These features provide a rationale for implementing a refined intervention in a randomized controlled trial with a larger number of practice sites and a more representative population. ACKNOWLEDGMENTS We are indebted to Jackie Hecht, M.P.H., who trained the health educators in techniques of motivational counseling and to Amy Hsi and Tara Murphy who conducted the counseling calls used in the study. Irma Miroshnik made substantial contributions to this work by designing and managing data systems. Anne Stoddard, Sc.D., served as the biostatistics consultant and Nadine Branstein, R.D., as the Registered Dietitian consultant. Alan Daly was responsible for the production of the manuscript. Dr. Gillman is a Robert Wood Johnson Generalist Physician Faculty Scholar. REFERENCES National Research Council National Academy of Sciences. Diet and health: implications for reducing chronic disease risk. In: Washington: National Academy Press, 1989:3-22. AICR. Food, nutrition and the prevention perspective. Washington: AICR, 1997.

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