Food parenting topics in social media posts: Development of a coding system, examination of frequency of food parenting concepts, and comparison across Reddit and Facebook.

This study presents development of a coding system to examine food parenting topics presented in posts on social media, and compared topics between two social media platforms (Facebook, Reddit). Publicly available social media posts were gathered from Facebook (2 groups) and Reddit (3 subreddits) and a coding system was developed based on the concept map of food parenting proposed by Vaughn et al. (2016). Based on the developed coding system, we coded posts into overarching food parenting practice constructs (coercive control: attempts to dominate, pressure or impose parents' will on child, structure: organization of child's environment to facilitate competence, autonomy support: supporting child's ability to self-regulate through allowing food choices, conversations about food, and a positive emotional climate) and recipes. We also coded posts dichotomously as including a question or advice-seeking. Differences in frequencies of food parenting constructs presented in posts on Facebook and Reddit were considered using chi-square tests of independence. Of the 2459 posts coded, 900 were related to food parenting (37%). In the subsample of 900, posts related to structure (43%) and recipes (40%) were the most frequent. Close to half of the posts (44%) included questions about food parenting. Frequency of food parenting topics in posts was related to social media platform, with coercive control and structure more frequently discussed on Reddit and recipes more commonly posted on Facebook. Results suggest that food parenting topics discuss on social media differ by platform, which can aid researchers and practitioners in targeting social media-based outreach to the topics of most interest for users. Findings give insight into the everyday food parenting topics and questions that parents and caregivers may be exposed to on social media. TAXONOMY: Development of Feeding; Parenting; Online Information Services.

Comparisons of school and home-packed lunches for fruit and vegetable dietary behaviours among school-aged youths.

OBJECTIVE: School-based interventions and policies encourage youths to include and consume fruits and vegetables at lunchtime via school lunches, but limited research has examined how these behaviours compare when youths have home-packed lunches. The objective of the present study was to compare fruit and vegetable contents and consumption among students having school or home-packed lunches over the school week. DESIGN: Participants were observed over five consecutive days at school lunchtime. Trained analysts estimated students' lunchtime fruit and vegetable contents and consumption using digital imaging. Mixed models examined associations between fruit and vegetable dietary behaviours and lunch source (school v. home-packed), controlling for student gender, grade and school. SETTING: Three elementary schools in northern California, USA.ParticipantsFourth-, fifth- and sixth-grade students (nchildren 315; nobservations 1421). RESULTS: Students were significantly less likely to have and to consume fruits and vegetables (all P<0·05) when having home-packed lunches, compared with when having school lunches. Among those who did have or did consume these foods, having a home-packed lunch was associated with consuming significantly less fruit (P<0·05) but no differences for other dietary outcomes. CONCLUSIONS: The study adds to a growing body of literature indicating shortfalls in fruit and vegetable contents and consumption associated with having a home-packed lunch, relative to having a school lunch. Findings suggest that school-based interventions, particularly when targeting home-packed lunches, should focus on whether or not these foods are included and consumed, with less emphasis on quantities.

Parental and family predictors of fruits and vegetables in elementary school children's home-packed lunches across a school week.

Home-packed lunches have been found to be of lower nutritional quality than school-bought lunches, yet little is known about family-based factors associated with lunch packing. The current exploratory study examines parental and family predictors of fruits and vegetables packed in lunches, hypothesizing parents' nutrition knowledge and authoritative parenting as well as children's involvement in lunch decisions would relate to packing more fruits and vegetables, while financial difficulties would relate to packing fewer. Ninety parent-child dyads from 4th-6th grade participated for 5 consecutive school days. Lunch contents were recorded using a digital imaging procedure to capture the number of days a fruit or vegetable was packed, and servings of fruits and vegetables in lunches each day. Parents completed family and parenting questionnaires and daily reports of child involvement in lunch decisions. Count-based regression models and longitudinal analyses within a multilevel modeling framework were used to examine predictors of lunch contents. Higher nutrition knowledge was associated with packing more fruit across the week and more vegetables on Monday. Authoritative parenting was associated with packing fewer vegetables on Monday, but more servings across the week. Financial stress was related to higher rates of never packing vegetables and when vegetables were packed including fewer servings, while child involvement in lunch decisions was associated with packing more fruits across the week, packing vegetables on more days and more servings of vegetables on Monday. Findings suggest parental and family factors impact the foods in packed lunches, with implications for children's dietary intake at school. Outreach programs can help parents pack more fruits and vegetables by providing nutrition education and suggestions for affordable, healthy lunch options as well as encouraging child involvement in the lunch packing process.

My Child at mealtime parent self-assessment of food related behaviors: Validation with mealtime behaviors.

My Child at Mealtime (MCMT) is a visually enhanced, self-assessment tool designed to measure parent food related behaviors of low-income caregivers of preschool-aged children. The current study examined the factor structure of MCMT and the correspondence between MCMT parent- and child-centered food related behaviors with observed behaviors during a mealtime with their preschool aged child. Caregivers (N = 175) completed MCMT, and a subsample (n = 60) had a mealtime videotaped in their home. Exploratory and confirmatory factor analysis supported a two-factor structure resulting in parent-centered and child-centered MCMT subscales. There was a significant association between parent-centered MCMT scores and observed parent-centered behaviors at mealtime. Behavioral correspondence of MCMT child-centered behaviors was generally weaker. Overall, the findings suggest that caregivers' MCMT responses provide a valid measure of parent food related behaviors.

Feasibility and reliability of digital imaging for estimating food selection and consumption from students' packed lunches.

Although increasing attention is placed on the quality of foods in children's packed lunches, few studies have examined the capacity of observational methods to reliably determine both what is selected and consumed from these lunches. The objective of this project was to assess the feasibility and inter-rater reliability of digital imaging for determining selection and consumption from students' packed lunches, by adapting approaches previously applied to school lunches. Study 1 assessed feasibility and reliability of data collection among a sample of packed lunches (n = 155), while Study 2 further examined reliability in a larger sample of packed (n = 386) as well as school (n = 583) lunches. Based on the results from Study 1, it was feasible to collect and code most items in packed lunch images; missing data were most commonly attributed to packaging that limited visibility of contents. Across both studies, there was satisfactory reliability for determining food types selected, quantities selected, and quantities consumed in the eight food categories examined (weighted kappa coefficients 0.68-0.97 for packed lunches, 0.74-0.97 for school lunches), with lowest reliability for estimating condiments and meats/meat alternatives in packed lunches. In extending methods predominately applied to school lunches, these findings demonstrate the capacity of digital imaging for the objective estimation of selection and consumption from both school and packed lunches.

How you look versus how you feel: Associations between BMI z-score, body dissatisfaction, peer victimization, and self-worth for African American and white adolescents.

Being overweight and having negative self-perceptions (body dissatisfaction) can have problematic consequences for adolescents physically, socially, and psychologically. Understanding associations between weight, self-perceptions, and peer experiences across ethnicities is particularly important given recent increases in obesity among ethnic minorities. The current study aimed to address these issues by examining Body Mass Index (BMI) z-scores and body dissatisfaction predicting change in general self-worth over time via peer victimization experiences in a diverse sample of 236 youth (ages 10-16 years). Body dissatisfaction predicted decreases in self-worth over time even after controlling for BMI z-score. BMI z-scores predicted decreases in self-worth over time only for white adolescents, whereas body dissatisfaction directly predicted decreases in self-worth for African American youth and indirectly via peer victimization for white youth. Associations were also considered by gender. Implications for intervention efforts for both white and African American adolescents are discussed.

The Relationship Between Maternal and Infant Sleep Duration Across the First Two Years.

OBJECTIVES: The first objective of this study was to determine how mother-infant sleep duration is related across the first 2 years of life. The second objective was to determine whether these relationships change across the first 2 years of life. The third objective was to understand demographic and health predictors of the relationship between maternal and child sleep. METHODS: Parents of 464 infants from the STRONG Kids 2 study reported their own and infants' nocturnal sleep duration and other health information (i.e., breastfeeding) at 3, 12, 18, and 24 months postpartum. RESULTS: Latent transition models revealed 2 mother-infant sleep profiles exist at 3 to 24 months. The low maternal sleep ( LMS ) pattern was characterized by lower maternal sleep duration than the recommended amount and lower infant sleep duration. The average maternal sleep ( AMS ) pattern was characterized by average maternal sleep duration meeting the recommended standard and average infant sleep duration. Approximately half of the mothers who started in the LMS profile transitioned to the AMS profile after 12 months postpartum. The sleep profiles stabilized after 12 months postpartum with limited transitions across 12 to 24 months. More infant-signaled nighttime wakings, later bedtimes, more infant sleep problems, and more exclusive breastfeeding were predictors of being in the LMS profile. CONCLUSION: Mother-infant sleep profiles stabilized after age 12 months, and mother-infant sleep profiles are driven by infant sleep quality during the night. The findings suggest the need to establish a healthy sleep routine for mothers and infants in the first year of life to promote longer-term sleep hygiene.

Understanding the patient experience of Classic Galactosemia in pediatric and adult patients: increased disease burden, challenges with daily living, and how they evolve over time.

BACKGROUND: Classic Galactosemia (CG) is a rare, autosomal recessive condition. Newborn screening and a timely galactose-restricted diet can resolve acute symptoms and decrease fatalities, but significant chronic, progressive morbidities remain and significantly impact daily life. The objective of this study was to better understand the burden of disease in children and adults with CGs and describe how morbidities evolve over time. METHODS: A total of 49 individuals with CG from the United States (US) were included in the qualitative surveys (13 adults [9 self-reported] and 36 pediatric patients). Fifteen follow-up interviews were conducted with 5 adults and 10 caregivers, discussing 17 individuals with CG overall (2 caregivers each discussed 2 children). RESULTS: Qualitative survey and interview data demonstrated the substantial burden of CG. Difficulties in a wide range of functions were experienced, which included: speech articulation; language and communication; cognition, memory and learning; emotions; and social interactions. Most difficulties appeared in childhood and persisted or worsened with age. Most adults did not live independently. Others lived semi-independently and experienced many daily challenges and required support. Caregivers also described the burden of caring for someone with CG and spoke about the impact this has on their day-to-day life, work, and relationships. CONCLUSIONS: These findings demonstrate the pronounced and persistent burden of disease encountered by individuals with CG, and that the condition has a significant impact on the quality of life of caregivers.

Qualitative interviews with adults with Classic Galactosemia and their caregivers: disease burden and challenges with daily living.

BACKGROUND: Classic Galactosemia is a rare, autosomal recessive disease in which galactose is not metabolized properly due to severe deficiency/absence of the galactose-1-phosphate uridylyltransferase (GALT) enzyme, converting to an aberrant and toxic metabolite, galactitol. Newborn screening and timely galactose-restricted diet can resolve acute symptoms and decrease fatalities. However, despite this, significant chronic, progressive morbidities remain which have a real impact upon daily life. To better understand the burden of disease, 20 in-depth qualitative interviews were undertaken with adult patients (n = 12), and their caregivers (n = 8), enrolled in the ACTION-Galactosemia trial, part of a clinical program designed to investigate the safety and efficacy of AT-007 (govorestat) in reducing toxic galactitol and long-term clinical outcomes in Classic Galactosemia. RESULTS: Interviews revealed the substantial burden of Classic Galactosemia on patients and families. Most adults were not able to live independently, and all required support with day-to-day activities. Short- and long-term memory difficulties and tremors were identified as the most frequently experienced and challenging symptoms. Other difficulties such as fine motor skills and slow/slurred speech contribute to the significant impact on daily activities, affecting ability to communicate and interact with others. Symptoms were first noticed in early childhood and worsened with age. Classic Galactosemia impacted all areas of daily functioning and quality of life, leading to social isolation, anxiety, anger/frustration and depression. This demonstrates the significant burden of disease and challenges associated with Classic Galactosemia. CONCLUSIONS: The impact on both patients and caregivers underscores the severity of the unmet medical need and the importance of pharmacological intervention to halt or prevent disease progression. Any treatment that could reduce symptoms or slow functional decline would ease the burden of this condition on patients and caregivers.

Bedtimes, bedtime routines, and children's sleep across the first 2 years of life.

STUDY OBJECTIVES: The first objective of this study was to determine whether establishing bedtime routines in the first year of life predicts better sleep outcomes (i.e. longer sleep duration, less nighttime waking, earlier bedtime, shorter sleep latency, fewer sleep problems) across the first 2 years of life. The second objective was to determine whether specific adaptive bedtime activities (e.g. book reading) were associated with sleep outcomes. The third objective was to describe changes in adaptive bedtime activities (hug/kiss caregiver, say goodnight to family) across the first 2 years of life. METHODS: Parents of 468 children from the STRONG Kids 2 birth cohort were surveyed about bedtime and bedtime routines, their child's sleep duration, nighttime waking, sleep latency, and sleep problems at 3, 12, 18, and 24 months of age. RESULTS: Cross-lagged panel models revealed partial evidence for reciprocal associations between bedtime routine consistency and adaptive bedtime activities and better sleep outcomes over time. Specifically, more bedtime routine consistency predicted less nighttime waking and sleep problems, and more bedtime adaptive activities predicted longer sleep duration and fewer sleep problems. DISCUSSION: The findings are discussed from a developmental perspective to highlight how consistency of bedtime routines established as early as 3 months of age may affect sleep outcomes and that the adaptive activities associated with these routines may increase in frequency over the first 2 years of life.

Connections between Friendship Quality, Peer Competence, and Obesity in Early Childhood through Adolescence.

Background: Research indicates that youths with overweight and obesity often face difficulties in peer relationships. The current research examined longitudinal associations between youths' peer competence (i.e., successful interactions with peers), friendship quality (i.e., disclosure, conflict resolution, and companionship with a best friend), and body mass index (BMI) z-score when they were 3 to 15 years of age. Methods: A subsample of 1292 majority White families from the National Institute of Child Health and Human Development (NICHD) Study of Early Child Care and Youth Development (SECCYD) were included in the analyses. Measured height and weight were used to compute BMI z-scores. Youths reported on their friendship quality starting when they were 8-9 years. Peer competence was assessed with an observation of dyadic peer play when participants were 3 years old, and with maternal reports after that. Associations were examined using autoregressive cross-lagged path models. Results: Bidirectional associations between peer competence and friendship quality were noted when participants were 8-9 and 15 years old. Greater BMI z-scores when youths were 3 and 10-11 years old predicted lower peer competence when they were 15 and 11-12 years old, respectively. Peer competence when youths were 11-12 years old was negatively associated with BMI z-score at 15 years old. Multigroup Structural Equation Modeling (SEM) indicated that significant paths differed between boys and girls. Conclusions: Findings extend previous literature considering peer outcomes and weight by examining associations as early as 3 years old, and indicate the need for early outreach to buffer against detrimental effects on developing peer competencies, especially for girls.

Parent Food-Related Behaviors and Family-Based Dietary and Activity Environments: Associations with BMI z-Scores in Low-Income Preschoolers.

Background: In early childhood, the family dietary and activity environment and parent food-related practices have been found to be important predictors of children's weight. However, few studies account for both of these factors, or the interaction between the 2, when assessing BMI in early childhood. This study aims to examine the association between the family-based dietary and activity environment (including intake, physical activity, and structure) and children's BMI z-scores in the context of parent food-related behaviors in low-income families during the preschool years. Methods: Parents (n = 111) completed questionnaires assessing the family-based dietary and activity environment, including diet, physical activity, screentime and sleep, and their use of parent food-related behaviors including parent-centered (i.e., controlling) and child-centered (i.e., autonomy supportive) practices. Children's BMI z-scores were calculated from researcher-measured height and weight. Results: Parent-centered food-related behaviors were directly related to children's BMI z-scores and moderated the association between the family-based dietary and activity environment and children's BMI z-scores. Family-based behaviors were associated with lower BMI only when parents used fewer parent-centered behaviors. Conclusions: Findings indicate that programs working with low-income families to prevent child obesity should stress both the creation of a healthy home environment and the use of positive parent food-related behaviors with preschool aged children.

Sprouts Growing Healthy Habits: Curriculum Development and Pilot Study.

High rates of childhood obesity and the impact this has on children's health make it important to establish a healthy lifestyle during the early school years. This pilot study explored the impact of a newly developed healthy habits curriculum. The Sprouts: Growing Healthy Habits curriculum presents topics such as energy balance, healthy sleep habits, and food groups through short activities and interactive book-reading. A nonrandomized controlled experimental study design was used to assess impact. Fifty-seven children between 5 and 6 years of age participated from two elementary schools (36 from the intervention school, 21 from the control school). Knowledge was assessed pre- and post-intervention in five content areas (farm to table, bedtime routines, portion size, energy expenditure, sugar content of beverages) using card sorting, ranking, and sequence activities. Within- and between-school comparisons were conducted using differences between groups and mixed modeling approaches. Within the intervention school, significant increases in knowledge were observed for farm to table, sugar content of beverages, and bedtime routines. For the control school, there was a significant increase in knowledge of portion sizes. Considering between-schools, only change in knowledge of bedtime routines remained significant, with greater increases in the intervention school. Results seem promising given the short dosage of curriculum. Increases in knowledge of healthy habits in early childhood may help in promoting healthy behaviors and combatting the effects of obesity.

Defining Food Education Standards through Consensus: The Pilot Light Food Education Summit.

BACKGROUND: Consistent with the Whole School, Whole Community, Whole Child Approach, food education encompasses nutritional status, culture, community, environment, and society. Unifying standards are needed to support food education integration in K-12 curricula. Pilot Light, a Chicago-based nonprofit, sought to generate such standards. This study reports a formative evaluation research process that led to the development of Food Education Standards (FES). METHODS: Nine FES were drafted within the context of the National Health Education Standards. The 2-day Pilot Light Food Education Summit convened 26 experts and community members to review draft FES. A facilitated, consensus-building process generated refined FES and K-12 competencies. Drawing on Summit outcomes and expert feedback, a team of teachers subsequently drafted final FES. Summit participants completed pre- and post-Summit surveys to assess changes in food education priorities. RESULTS: The initial 9 FES were refined to 7. Comparison data indicated shifts in endorsed priorities for food education, moving from prioritizing specific knowledge, such as "categorizing food into food groups," toward "students having a conscious decision-making process around food." CONCLUSIONS: Developed with input from experts across multidisciplinary fields, the evidence-based Pilot Light FES can be feasibly implemented in multiple subjects across all school types and community socio-demographic levels.

Assessment of an e-training tool for college students to improve accuracy and reduce effort associated with reading nutrition labels.

Objective: Nutrition labels are often underutilized due to the time and effort required to read them. We investigated the impact of label-reading training on effort, as well as accuracy and motivation. Participants: Eighty college students (21 men and 59 women). Methods: The training consisted of a background tutorial on nutrition followed by three blocks of practice reading labels to decide which of two foods was the relatively better choice. Label-reading effort was assessed using an eye tracker and motivation was assessed using a 6-item scale of healthy food-choice empowerment. Results: Students showed increases in label-reading accuracy, decreases in label-reading effort, and increases in empowerment. Conclusions: The nutrition label e-training tool presented here, whether used alone or as part of other wellness and health programs, may be an effective way to boost students' label-reading skills and healthy food choices, before they settle into grocery shopping habits.

Sources of Information and Support for Breastfeeding: Alignment with Centers for Disease Control and Prevention Strategies.

BACKGROUND AND OBJECTIVES: Research consistently supports health benefits of breastfeeding; however, rates in the United States remain below Healthy People 2020 goals. To increase breastfeeding, information and support are needed from multiple sources. Given differences in breastfeeding rates by demographic characteristics, sources of information and support may also differ. In addition, recent research suggests potential differences in health outcomes related to feeding method (direct breastfeeding only, feeding expressed human milk, combination-feeding with formula). This study examined (1) information and support received within Centers for Disease Control and Prevention (CDC)-defined strategies for supporting breastfeeding mothers, (2) differences in rates of information and support received by demographics, and (3) associations with feeding method at 6 weeks postpartum. MATERIALS AND METHODS: A sample of 447 women participating in the Synergistic Theory Research Obesity and Nutrition Group (STRONG) Kids 2 study completed surveys with questions from the CDC Survey on Infant Feeding Practices II related to sources of information and support for breastfeeding and breast pump use, and about demographics and feeding method at 6 weeks postpartum. RESULTS: Frequencies of supports received within each category indicate that professional supports were the most pervasive, followed by support from friends and relatives. However, women at greater risk for breastfeeding cessation (lower education, Women, Infants, and Children participants, single mothers) received information and support at lower rates. Education and information support was the only source significantly associated with feeding method. CONCLUSION: New approaches are needed to increase efficacy of information delivery, especially for at-risk populations, to better meet CDC recommendations.

An Evaluation of an eHealth Tool Designed to Improve College Students' Label-Reading Skills and Feelings of Empowerment to Choose Healthful Foods.

OBJECTIVE: College students are at risk for poor dietary choices. New skills can empower individuals to adopt healthful behaviors, yet eHealth tools designed to develop food-choice skills, such as label-reading skills, are uncommon. We investigated the effects of web-based label-reading training on college students' perceptions of healthful food-choice empowerment. METHODS: Students completed label-reading training in which they practiced selecting the more healthful food using nutrition labels. We examined improvements in label-reading accuracy (correct healthfulness decisions) and perceptions of empowerment, using a 6-item scale. Repeated measures ANOVAs and paired-samples t-tests were used to examine changes in accuracy and empowerment across the training session. RESULTS: In addition to increases in label-reading accuracy with training, we found increases in healthful food-choice empowerment scores. Specifically, the proportion of correct (i.e., more healthful) food choices increased across the three blocks of practice (p = 0.04) and food-choice empowerment scores were about 7.5% higher on average after training (p < 0.001). CONCLUSION AND IMPLICATIONS: Label-reading training was associated with increased feelings of empowerment associated with making healthful food choices. Skill focused eHealth tools may offer an important avenue for motivating behavior change through skill development.

A Multicomponent, School-Based Intervention, the Shaping Healthy Choices Program, Improves Nutrition-Related Outcomes.

OBJECTIVE: To evaluate the effectiveness of the Shaping Healthy Choices Program (SHCP). DESIGN: A clustered, randomized, controlled intervention lasting 1 school year. SETTING: Schools in northern and central California. PARTICIPANTS: Fourth-graders (aged 9-10 years) at 2 control schools (n = 179) and 2 intervention schools (n = 230). INTERVENTION: Garden-enhanced education, family, and community partnerships; increased regionally procured produce in the lunchroom; and school-site wellness committees. MAIN OUTCOME MEASURES: Changes in body mass index (BMI) percentiles/Z-scores; nutrition knowledge, science process skills, and vegetable identification and preferences; and reported fruit and vegetable intake. ANALYSIS: Student t test, chi-square, ANOVA of change, and multilevel regression mixed model to evaluate change in outcomes with school as a random effect to account for cluster design effects. Statistical significance was set at P < .05. RESULTS: There was a greater improvement in BMI percentile (-6.08; P < 0.01), BMI Z-score (-0.28; P < .001), and waist-to-height ratio (-0.02; P < .001) in the intervention compared with the control schools. CONCLUSIONS AND IMPLICATIONS: The SHCP resulted in improvements in nutrition knowledge, vegetable identification, and a significant decrease in BMI percentiles. This supports the concept that the SHCP can be used to improve the health of upper elementary school students.

Associations Between Adolescents' Weight and Maladjustment Differ With Deviation From Weight Norms in Social Contexts.

BACKGROUND: In line with the reflected self-appraisal hypothesis, previous research finds associations between weight and maladjustment are strongest when there is a mismatch between individuals' weight and the weight norm of their social contexts. However, research has not considered associations in more proximal social contexts. We examined differences in associations between weight and maladjustment for 2 proximal social contexts: grade-level peers and friendship groups. METHODS: We used sixth-graders (N = 565; Mage = 12 years) self-reported height and weight (used to calculate body mass index (BMI) z-score), experiences of peer victimization, and depressive symptoms. Deviation from the normative weight was calculated as the students' BMI z-score minus the average BMI z-score for the context (grade-level peers or friendship group). RESULTS: Considering deviations from grade-level peers, greater BMI z-scores were associated with more self-reported peer victimization only for students above the weight norm. For the friendship group, greater weight was associated with more self-reported depressive symptoms only for those who were above the normative weight. CONCLUSIONS: Being heavier during adolescence may be especially problematic for students who differ from the norm in their proximal social contexts. Intervention efforts focused on weight and maladjustment may want to consider the contexts involved in adolescents' self-appraisals.

Mycophenolate mofetil substitution for cyclosporine a in renal transplant recipients with chronic progressive allograft dysfunction: the "creeping creatinine" study.

BACKGROUND: This study determined whether cyclosporine A (CsA)-treated renal allograft recipients with deteriorating renal function ("creeping creatinine") secondary to chronic allograft nephropathy (CAN) benefit from the addition of mycophenolate mofetil (MMF) to their immunosuppressive regimen, followed by withdrawal of CsA. METHODS: In a controlled, open, multicenter study, CsA-treated renal allograft recipients with progressively deteriorating renal function were randomized to have their CsA discontinued with the concomitant addition of MMF to their regimen (group A) or to continue treatment with CsA (group B). The primary endpoint was the response rate over the 6-month period after withdrawal of CsA in group A or the equivalent time in group B. Response was defined as a stabilization or reduction of serum creatinine (SCr), as evidenced by a flattening or positive slope of the 1/SCr plot and no graft loss. Secondary endpoints included the incidence of acute rejection, graft and patient survival, and changes in selected metabolic parameters. RESULTS: The response rate in the primary intent-to-treat population (n=122) was 58% (36/62) in group A versus 32% (19/60) in group B (P=0.0060). The corresponding percentages of responders in the per-protocol population (n=107) were 60% (36/60) and 26% (12/47), respectively (P=0.0008). There were no acute rejections in group A during the study period. Patients in this group also experienced a significant decrease in total cholesterol. CONCLUSIONS: In patients with progressively deteriorating renal function secondary to CAN, addition of MMF followed by withdrawal of CsA results in a significant improvement in transplant function without the risk of acute rejection.