Janeen B. Leon

Effect of Food Additives on Hyperphosphatemia Among Patients With End-stage Renal Disease: A Randomized Controlled Trial

CONTEXT High dietary phosphorus intake has deleterious consequences for renal patients and is possibly harmful for the general public as well. To prevent hyperphosphatemia, patients with end-stage renal disease limit their intake of foods that are naturally high in phosphorus. However, phosphorus-containing additives are increasingly being added to processed and fast foods. The effect of such additives on serum phosphorus levels is unclear. OBJECTIVE To determine the effect of limiting the intake of phosphorus-containing food additives on serum phosphorus levels among patients with end-stage renal disease. DESIGN, SETTING, AND PARTICIPANTS Cluster randomized controlled trial at 14 long-term hemodialysis facilities in northeast Ohio. Two hundred seventy-nine patients with elevated baseline serum phosphorus levels (>5.5 mg/dL) were recruited between May and October 2007. Two shifts at each of 12 large facilities and 1 shift at each of 2 small facilities were randomly assigned to an intervention or control group. INTERVENTION Intervention participants (n=145) received education on avoiding foods with phosphorus additives when purchasing groceries or visiting fast food restaurants. Control participants (n=134) continued to receive usual care. MAIN OUTCOME MEASURE Change in serum phosphorus level after 3 months. RESULTS At baseline, there was no significant difference in serum phosphorus levels between the 2 groups. After 3 months, the decline in serum phosphorus levels was 0.6 mg/dL larger among intervention vs control participants (95% confidence interval, -1.0 to -0.1 mg/dL). Intervention participants also had statistically significant increases in reading ingredient lists (P<.001) and nutrition facts labels (P = .04) but no significant increase in food knowledge scores (P = .13). CONCLUSION Educating end-stage renal disease patients to avoid phosphorus-containing food additives resulted in modest improvements in hyperphosphatemia. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00583570.

Impact of Navigators on Completion of Steps in the Kidney Transplant Process: A Randomized, Controlled Trial

BACKGROUND AND OBJECTIVES Many patients with ESRD, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These eight sequential steps are as follows: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. This study sought to determine the effect of navigators on completion of steps. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS Cluster randomized, controlled trial at 23 Ohio hemodialysis facilities. One hundred sixty-seven patients were recruited between January 2009 and August 2009 and were followed for up to 24 months or until study end in February 2011. Trained kidney transplant recipients met monthly with intervention participants (n=92), determined their step in the transplant process, and provided tailored information and assistance in completing the step. Control participants (n=75) continued to receive usual care. The primary outcome was the number of transplant process steps completed. RESULTS Starting step did not significantly differ between the two groups. By the end of the trial, intervention participants completed more than twice as many steps as control participants (3.5 versus 1.6 steps; difference, 1.9 steps; 95% confidence interval, 1.3-2.5 steps). The effect of the intervention on step completion was similar across race and sex subgroups. CONCLUSIONS Use of trained transplant recipients as navigators resulted in increased completion of transplant process steps.

The Prevalence of Phosphorus-Containing Food Additives in Top-Selling Foods in Grocery Stores

OBJECTIVE The objective of this study was to determine the prevalence of phosphorus-containing food additives in best-selling processed grocery products and to compare the phosphorus content of a subset of top-selling foods with and without phosphorus additives. DESIGN The labels of 2394 best-selling branded grocery products in northeast Ohio were reviewed for phosphorus additives. The top 5 best-selling products containing phosphorus additives from each food category were matched with similar products without phosphorus additives and analyzed for phosphorus content. Four days of sample meals consisting of foods with and without phosphorus additives were created, and daily phosphorus and pricing differentials were computed. MAIN OUTCOME MEASURES Presence of phosphorus-containing food additives, phosphorus content. RESULTS Forty-four percent of the best-selling grocery items contained phosphorus additives. The additives were particularly common in prepared frozen foods (72%), dry food mixes (70%), packaged meat (65%), bread and baked goods (57%), soup (54%), and yogurt (51%) categories. Phosphorus additive-containing foods averaged 67 mg phosphorus/100 g more than matched nonadditive-containing foods (P = .03). Sample meals comprised mostly of phosphorus additive-containing foods had 736 mg more phosphorus per day compared with meals consisting of only additive-free foods. Phosphorus additive-free meals cost an average of

Can a Nutrition Intervention Improve Albumin Levels Among Hemodialysis Patients? A Pilot Study

2.00 more per day. CONCLUSION Phosphorus additives are common in best-selling processed groceries and contribute significantly to their phosphorus content. Moreover, phosphorus additive foods are less costly than phosphorus additive-free foods. As a result, persons with chronic kidney disease may purchase these popular low-cost groceries and unknowingly increase their intake of highly bioavailable phosphorus.

Fast food, phosphorus-containing additives, and the renal diet.

OBJECTIVE To determine the effect of a tailored intervention on albumin levels among hemodialysis patients. DESIGN Randomized controlled trial. SETTING Eight freestanding chronic hemodialysis units in northeast Ohio. SUBJECTS Eighty-three randomly selected adult patients who had been on dialysis for at least 6 months and had a mean albumin <3.7 g/dL (bromcresol green method) or <3.4 g/dL (bromcresol purple method) for the last 3 months. To better elucidate the feasibility and outcomes of the intervention, we selected more intervention than control patients. INTERVENTION Dietitians of the 52 intervention patients determined whether any of the following potential barriers to adequate protein nutrition were present for each patient: (1) poor knowledge of protein-containing foods, (2) poor appetite, (3) needing help shopping or cooking, (4) low fluid intake, and (5) inadequate dialysis. Depending on the specific barriers present, the dietitians (1) educated patients on protein-containing foods, (2) recommended snacks for which patients had preserved appetite, (3) helped set up social supports, (4) provided recommendations on fluid intake, and/or (5) arranged for improved dialysis. Dietitians of the 31 control patients continued to provide usual care. MAIN OUTCOME MEASURES Change in albumin after 6 months, stratified as minimal change (less than.25 g/dL increase or decrease), moderate improvement (.25 to.49 g/dL increase), and large improvement (increase of .50 g/dL or more). To examine the role of inflammatory states, we also determined serum C-reactive protein levels at the beginning and end of the trial. RESULTS Among intervention patients, 29% had a minimal change in albumin, 44% had a moderate improvement, and 27% had a large improvement. Among control patients, 74% had a minimal change in albumin, 19% had a moderate improvement, and 6% had a large improvement (P <.001 for comparison of intervention and control subjects). About 60% of subjects had high baseline C-reactive protein levels (> 10 mg/L). However, there was little relationship between change in albumin and either baseline C-reactive protein levels or changes in C-reactive protein levels (P = .83). CONCLUSION A nutrition intervention tailored to patient-specific barriers resulted in improved albumin levels even among patients with high C-reactive protein levels. Further work is needed to refine and test this intervention on a larger sample.

Effect of an iPod Video Intervention on Consent to Donate Organs: A Randomized Trial

OBJECTIVE Fast food is commonly consumed by hemodialysis patients, but many menu items are not compatible with renal diets because of their sodium, potassium, or phosphorus content. Moreover, the phosphorus content of fast foods is difficult for patients to estimate, because phosphorus-containing additives are commonly added to many fast foods. We sought to determine how many fast-food entrees and side dishes are compatible with renal diets. METHODS We examined nutrition-facts labels and ingredient lists provided by 15 fast-food chains. Each entree and side dish was first assessed according to traditional criteria (limited sodium, potassium, and naturally occurring phosphorus content), and then according to the presence of a phosphorus -containing additive. RESULTS Of 804 total entrees across all restaurants, 415 (52%) were acceptable according to traditional criteria, but only 128 (16%) were also free of phosphorus-containing additives. Of 163 total side dishes, 37 (23%) were acceptable according to traditional criteria, and 27 (17%) were also free of phosphorus-containing additives. There were no acceptable entrees at 3 chains, and no acceptable side dishes at 5 chains. CONCLUSION Only a small proportion of fast-food entrees and side dishes are compatible with renal diets. The widespread use of phosphorus-containing additives is a major impediment to the availability of acceptable fast-food choices for hemodialysis patients. We recommend limiting the use of phosphorus-containing additives, and including phosphorus content in nutrition-facts labels.

Barriers to adequate protein nutrition among hemodialysis patients

BACKGROUND The gap between the supply of organs available for transplantation and demand is growing, especially among ethnic groups. OBJECTIVE To evaluate the effect of a video designed to address concerns of ethnic groups about organ donation. DESIGN Cluster randomized, controlled trial. Randomization was performed by using a random-number table with centralized allocation concealment. Participants and investigators assessing outcomes were not blinded to group assignment. (ClinicalTrials.gov registration number: NCT00870506) SETTING Twelve branches of the Ohio Bureau of Motor Vehicles in northeastern Ohio. PARTICIPANTS 952 participants aged 15 to 66 years. INTERVENTION Video (intervention; n = 443) or usual Bureau of Motor Vehicles license practices (control; n = 509). MEASUREMENTS The primary outcome was the proportion of participants who provided consent for organ donation on a newly acquired drivers license, learners permit, or state identification card. Secondary outcomes included willingness to make a living kidney donation to a family member in need and personal beliefs about donation. RESULTS More participants who viewed the video consented to donate organs than control participants (84% vs. 72%; difference, 12 percentage points [95% CI, 6 to 17 percentage points]). The video was effective among black participants (76% vs. 54%; difference, 22 percentage points [CI, 9 to 35 percentage points]) and white participants (88% vs. 77%; difference, 11 percentage points [CI, 5 to 15 percentage points]). At the end of the trial, fewer intervention than control participants reported having insufficient information about organ donation (34% vs. 44%; difference, -10 percentage points [CI, -16 to -4 percentage points]), wanting to be buried with all of their organs (14% vs. 25%; difference, -11 percentage points [CI, -16 to -6 percentage points]), and having conflicts with organ donation (7% vs. 11%; difference, -4 percentage points [CI, -8 to -2 percentage points]). LIMITATION How the observed increases in consent to donate organs might translate into a greater organ supply in the region is unclear. CONCLUSION Exposure to a brief video addressing concerns that ethnic groups have about organ donation just before obtaining a license, permit, or identification card increased consent to donate organs among white and black participants. PRIMARY FUNDING SOURCE National Institutes of Health and the Robert Wood Johnson Foundation.

Public Health Approach to Addressing Hyperphosphatemia Among Dialysis Patients

OBJECTIVE Determine the relative importance of potential medical, behavioral, and socioeconomic barriers to adequate protein nutrition among hemodialysis patients. DESIGN Cross-sectional study. SETTING All 22 chronic hemodialysis units in northeast Ohio. PATIENTS 298 randomly selected chronic hemodialysis patients. INTERVENTION We interviewed and abstracted the chart of each patient to assess protein nutritional status (albumin and protein catabolic rate), potential medical barriers (poor appetite, inadequate dialysis, bioincompatible dialysis membrane, difficulty chewing, and comorbid conditions), potential behavioral barriers (knowledge of protein containing foods and dietary noncompliance), and potential socioeconomic barriers (expense of protein containing foods and needing help shopping and cooking). MAIN OUTCOME MEASURE We used logistic regression to examine the relationship between protein nutritional status and potential barriers. RESULTS Albumin levels of <35 g/L were independently associated with Kt/V of <1.2 (odds ratio, 2.4), having more than three comorbid conditions (odds ratio, 4.0), inability to name any protein-containing foods (odds ratio, 2. 3), and needing help shopping and cooking (odds ratio, 2.6). Normalized protein catabolic rate of <1.0 g/kg/d was independently associated with poor appetite (odds ratio, 3.3), Kt/V of <1.2 (odds ratio, 3.1), and dietary compliance as indicated by low interdialytic fluid gain (odds ratio, 2.2). CONCLUSION Three medical factors (poor appetite, inadequate dialysis, and comorbid conditions), two behavioral factors (lack of knowledge of protein containing foods and low interdialytic fluid gain), and one socioeconomic factor (needing help shopping and cooking) are independently associated with inadequate protein nutrition among hemodialysis patients. Further work is needed to develop interventions to overcome these barriers and to determine the effect of such interventions on protein nutrition and patient mortality and morbidity.

Direct Messaging to Parents/Guardians to Improve Adolescent Immunizations

Elevated serum phosphorus levels are a major source of morbidity and mortality for the 350,000 Americans receiving chronic dialysis treatment. Despite the widespread application of medical and behavioral interventions, the prevalence of hyperphosphatemia remains exceedingly high. At first glance, a public health perspective may seem inappropriate for addressing a disorder of mineral metabolism among patients receiving a life-sustaining treatment. However, we analyzed this topic from a public health perspective and identified many opportunities to improve the management of hyperphosphatemia, including (1) media and cultural messages about food, (2) the availability of appropriate foods and medications, (3) physical structures such as the location of products in grocery stores, and (4) social structures such as food-labeling laws.

Determinants of metabolic acidosis among hemodialysis patients.

PURPOSE To study the impact on adolescent immunization rates of direct messages to parents/guardians. METHODS Electronic health record rules identified adolescents needing an immunization. Parents/guardians of adolescents were messaged via a single vendor using automated text, prerecorded voice, and/or postcard. RESULTS Parents/guardians of 3,393 patients, ages 11-18 years, with one or more primary care visits in the prior 2 years, identified as needing (average of 2.04 years) a vaccination (meningococcal conjugate, human papillomavirus, or tetanus, diphtheria, and pertussis vaccines) were messaged (mean age, 14 years; 50% male; 38% African-American; 23% white; 19% Hispanic; and 79% public health insurance). A total of 7,094 messages were sent: 3,334 automated voice (47%), 2,631 texts (37%), and 1,129 postcards (16%). After the first message, 865 adolescents (25.5%) received at least one vaccine. Within 24 weeks of messaging 1,324 vaccines (745 human papillomavirus; 403 meningococcal conjugate; and 176 tetanus, diphtheria, and pertussis vaccines) occurred in 959 visits (83.8% physician visits and 16.2% nurse visits). Average visits generated