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* Division of Behavioral Medicine and Clinical Psychology
Cystic Fibrosis Center, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio
|| Division of Developmental and Behavioral Pediatrics, Greenville Hospital System Children's Hospital, Greenville, South Carolina
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONREFERENCES |
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Methods. Of 14 eligible children, 10 were randomly assigned and initiated treatment (71% recruitment rate). Four participants were randomly assigned to BEH, and 6 were assigned to CTL (5 of whom chose to crossover to BEH). BEH included nutrition counseling to increase energy intake (via types of foods and addables/spreadables) and child behavioral management training to teach parents differential attention and contingency management skills. CTL was consistent with the 2002 CF Foundation Consensus Conference Guidelines for nutritional care.
Results. BEH led to greater increases in energy intake pre- to posttreatment than CTL as measured by calories per day (842 kcal/day vs –131 kcal/day change). On receiving BEH, the change in energy intake was replicated with the CTL group (892 kcal/day change). At 3- and 12-month follow-up, energy intake was maintained (672 kcal/day increase from baseline and 750 kcal/day increase from baseline, respectively). Children in this study met or exceeded normal weight and height velocities from pretreatment to the 3-month follow-up (mean weight: 1.4 kg/6 months; mean height: 5.1 cm/6 months) and from posttreatment to the 12-month follow-up (mean weight: 2.5 kg/12 months; mean height: 8.3 cm/12 months).
Conclusions. Toddlers and preschoolers who have CF and received BEH were able to meet the energy intake recommendations for this disease and maintain these gains up to 12 months after treatment. In addition, these children demonstrated weight and height velocities from pretreatment to 12-month follow-up, consistent with the goal of normal growth. BEH is a promising, evidence-based, early nutritional intervention for children with CF. An upcoming multisite clinical trial will test BEH versus an attention control condition using a larger sample (N = 100), providing additional evidence about the efficacy of this treatment for energy intake and growth in young children with CF.
Key Words: chronic illness • growth • behavioral therapy • parent training • pediatric psychology
Abbreviations: CF, cystic fibrosis • RDA, recommended dietary allowance • BEH, behavioral and nutrition intervention • CTL, usual care control intervention • CDC, Centers for Disease Control and Prevention • NDS-R, Nutrition Data Systems for Research
Toddlers and preschoolers with cystic fibrosis (CF) are not meeting the nutritional recommendations for this disease.1–4 These recommendations include energy intake of 120% or greater of the recommended dietary allowance (RDA) per day and percentage of fat intake of 35% to 40% per day.5,6 These nutritional recommendations are considered the level of energy intake necessary for patients with CF to meet the goal of normal growth.5 Current clinical interventions are not optimizing growth in young children with CF.7,8 This is a clinically significant problem because improved growth from 3 to 6 years of age is independently and positively predictive of better lung function at age 6 for young children with CF.9 Optimizing growth early in life may change the course of clinical lung disease and lead to less morbidity and mortality in this disease.10 However, for the nutritional care of young children with CF to advance, better interventions must be developed.1,8
Behavioral factors such as mealtime duration, family mealtime interactions, and child mealtime behaviors limit dietary adherence in children with CF.1,4,11–15 For example, observations of young children with CF revealed longer meals than healthy peers, and longer meal duration has demonstrated negative associations with both weight percentile for age and the number of behavioral problems reported by parents at mealtime.1,4,16 Problematic mealtime behaviors have been found to be negatively associated with children's energy intake.17 Nutrition interventions that incorporate behavioral therapies have shown promise in increasing energy intake in children with CF.18–20 To establish further the efficacy of behavioral and nutrition treatment for toddlers and preschoolers with CF and pancreatic insufficiency, we conducted a randomized clinical trial focused on children aged 18 to 48 months. The purposes were to increase energy intake, meet or exceed the goal of at least 120% recommended dietary intake for energy per day, and optimize growth.
We pursued 3 aims in this study. First, we conducted a randomized clinical trial to compare a behavioral and nutrition treatment (BEH) with a usual/standard care control condition (CTL) over an 8-week period. The primary endpoint was energy intake per day pretreatment and posttreatment. The secondary endpoint was the percentage of participants who met the energy intake goal of 120% RDA of energy per day or greater. This endpoint was chosen as a clinically meaningful measure of treatment outcome according to the CF Foundation Consensus Conference guidelines for pediatric nutrition in CF.1,5,6 Second, for further testing the efficacy of BEH, participants who were randomly assigned to the CTL condition were offered the opportunity to participate in the BEH on completing the randomized trial. This within-subject analysis examined the same endpoints before beginning the CTL condition ("baseline"), at the end of the CTL condition ("pretreatment"), and again after the family completed BEH ("posttreatment"). Third, for examining the durability of BEH, all participants who completed the intervention were assessed at 3 and 12 months after treatment. The endpoints remained the same in this within-subject analysis, and the measures were examined before beginning BEH ("pretreatment"), after BEH ("posttreatment"), and 3 and 12 months thereafter ("follow-up"). During the follow-up period, families received usual care but had no contact with the staff who conducted the clinical trial. As part of this third aim, we were also able to examine growth velocity from pretreatment to the 3-month follow-up and from posttreatment to the 12-month follow-up (
6- and 12-month periods, respectively). For purposes of understanding the anthropometric data within a clinical context, we chose to benchmark them against normal growth in young children. We defined this benchmark as the expected weight and height velocities over 6 or 12 months for a same-aged child who did not have CF and was growing at the 50th percentile based on the 2000 Centers for Disease Control and Prevention (CDC) growth charts.21
For aim 1, we hypothesized that children who received BEH would improve their energy intake per day more than children receiving usual care. In addition, the percentage of children who exceeded 120% RDA for energy per day would be greater after treatment for the BEH versus the CTL condition.
For aim 2, we hypothesized that children would not improve energy intake during CTL but when they received the BEH would replicate the improvements found for children who received that treatment as part of aim 1. We predicted a similar change in the percentage of children who exceeded 120% RDA of energy per day after receiving BEH.
For aim 3, we hypothesized that the improvements in energy intake and percentage RDA per day that were produced by the BEH would be maintained for 3 and 12 months after intervention. Finally, we hypothesized that children who received BEH would meet or exceed the benchmark for normal weight and height velocity over the 6-month period from pretreatment to the 3-month follow-up and the 12-month period from posttreatment to the 12-month follow-up.
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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Twenty-one children were in the age range of 18 to 48 months, and 14 met the criteria for enrollment. Two families did not regularly attend clinic and could not be reached by telephone. Two families, although expressing interest in helping their child improve his or her nutritional status, declined to participate because of an inability to commit the time needed to attend weekly treatment sessions regularly over an 8-week period. Thus, 10 of the 14 families who met the inclusion criteria were enrolled and randomly assigned (71% of eligible families), with 4 receiving the BEH and 6 receiving CTL. The study was approved by the institutional review board of Cincinnati Children's Hospital, and the child's parent provided written informed consent (see Fig 1 for a CONSORT flow diagram of participant recruitment, allocation, and participation).
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Interventions
BEH
BEH combined individualized nutritional counseling that targeted increasing energy intake in 1 meal each week and parent training of effective child behavior management skills.22–24 Treatment occurred over an 8-week period and included a baseline study visit (week 1) and 6 intervention sessions held in weeks 3 to 8. Each intervention session included both nutritional counseling and behavioral treatment components. An individual therapy approach was used (see Table 1 for details about the content of each session). Overall, the treatment curriculum focused on 3 areas: (1) increasing calorie and fat intake, with a goal of meeting the 120% to 150% RDA for energy and 35% to 40% of calories derived from fat, (2) ensuring appropriate dosage and timing of pancreatic enzyme replacements plus regular meal schedule, and (3) teaching effective parent management skills to address common behavioral challenges of toddlers and preschoolers at mealtime (including active praising of eating behaviors, ignoring of noneating behaviors, setting clear time limits for meals, and using contingencies to motivate young children to meet the energy goals that had been set for the week). Parents were asked to use the behavioral parenting skills regularly at home at all meals and snacks. Using the data from each child's baseline diet record, individualized goals were set for energy intake. A general guideline involved increases of 200 calories for snacks and 175 for meals, with a total goal of 600 to 800 calories per day change pre- to posttreatment. By focusing on 1 meal per session, the goals moved from a 200-calorie increase when snacks were the focus (session 2) to 375 when breakfast goals were added (session 3), 550 when lunch goals were added (session 5), and, finally, 825 when dinner goals were added (session 6; see Table 1 for an illustration of the session flow and content). Individual sessions were conducted by a PhD-level therapist in an outpatient clinic setting. One child from the CTL who chose to participate in BEH received sessions 3 to 7 via telephone because of the family's distance from the clinic. Families completed weekly diet diaries during BEH, and these data were used to assess progress with treatment goals. Session notes that were kept by the therapist and observations of parent–child mealtime interactions during the practice meal that occurred at session 4 were used to assess whether parents were implementing the behavioral strategies at home. Review of the diaries, session notes, and practice meals indicated that parents were learning and implementing the behavioral and nutrition changes targeted by BEH.
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Outcomes
Energy Intake
Measured via weighed 7-day diet diaries (baseline, pre- and posttreatment, and 3-month follow-up)
Children's energy intake was measured using 7-day diet diaries.25 At an initial study visit for BEH and CTL, all families were provided with a food scale as well as measuring cups and spoons. Families were taught how to measure food and complete the diet diary. Specifically, session 1 for both BEH and CTL involved a 60- to 75-minute training visit that included detailed and standardized verbal instructions, modeling and rehearsal with the measurement tools and actual foods/liquids, and written instructions. Diaries were completed for 1 week before intervention and for 1 week after intervention (8 weeks apart) by both groups. BEH families completed diaries weekly throughout the intervention. An additional 7-day diary was completed at the 3-month follow-up assessment for all families who participated in BEH. At each study visit, the diet records were reviewed for completeness, questions were answered, and the instructions for accurately and thoroughly completing the records were discussed. All diet diaries were analyzed by a registered dietitian who was masked to participants' group assignment as well as phase in treatment. Diaries were analyzed using the Nutrition Data Systems for Research (NDS-R) software version 5.0 developed by the Nutrition Coordinating Center at the University of Minnesota (Minneapolis, MN).26 Information was obtained on total energy intake, percentage RDA of energy intake per day (with 100% set at 1300 calories per day1,27), and the percentage of calories from fat.
Measured via 3-day 24-hour recall diet diaries (12-month follow-up)
Children's energy intake at the 12-month follow-up was collected for 3 days (2 weekdays and 1 weekend day) using a 24-hour recall method.28 This method was used because it is known to be a valid approach for group estimates of energy intake in young children, and it was more convenient for families.28 The diaries were conducted by a registered dietitian who was trained to conduct recall interviews using the NDS-R software. NDS-R uses the multiple-pass system of the interview method. Interview prompts guide and standardize data entry. Eight of the 9 (89%) patients who completed BEH were able to provide diet data at the 12-month follow-up.
Weight and Height
Children's weight (kg) and height (cm) were measured at baseline/pretreatment, posttreatment, and 3- and 12-month follow-ups by trained research personnel using a standardized measurement protocol during a visit to the medical center. Weight was obtained using a digital Scaletronix scale (Wheaton, IL). Height was measured using a Holtain stadiometer (Crymych, England).
Sample Size
Power Analysis
The primary outcome measure of this clinical trial was change in average energy intake per day over a 7-day period from pre- to posttreatment for the BEH and CTL conditions. Our previous work provided data on which to base the a priori power analysis for this trial.1,18,20 The 100% RDA for energy for toddlers and preschoolers is 1300 kcal/day. In a sample of 35 toddlers with CF, we found the average intake to be 1090 (SD: 283). In our previous treatment studies with preschool- and school-age children with CF, behavioral treatment over 9 weeks produced calorie increases of 800 to 1000 kcal/day. In this trial with younger children, we targeted an increase of 600 to 800 kcal/day for the BEH condition over 8 weeks of active treatment. In the only previous study of behavioral treatment to include a usual care control condition, over 9 weeks the control group of 3 children with CF (mean: 6 years of age) showed an increase of 244 kcal/day (SD: 370). In this trial, we estimated an increase of 250 kcal/day for the CTL condition in younger children. We estimated variability in calorie intake per day at 370.
On the basis of these data, a power analysis for the primary endpoint of energy intake per day was calculated with the following assumptions: one-tailed test set at the P = .05 level, change in average energy intake per day from pre- to posttreatment of 650 for BEH and 250 for CTL (difference of 400 between the 2 conditions and the BEH condition reaching an average of 134% RDA of energy per day), and SD for energy intake of 370. A sample size of 12 per condition was estimated to have a statistical power estimate of 82%. When we had recruited and completed aim 1 for the 10 families who participated in this randomized clinical trial, we conducted an interim data analysis as part of the data and safety monitoring plan for this project. At that time, statistically and clinically significant results had been obtained for our primary endpoint, energy intake, and our secondary endpoint, percentage of participants who obtained at least 120% RDA of energy intake per day. In addition, preliminary results for aim 2 demonstrated a clear replication of the impact of BEH on these endpoints. For this reason, aim 2 and aim 3 were completed and no new participant enrollment was initiated.
Statistical Methods
Statistical analyses were preformed using SPSS 11.0 software. The following analyses were conducted:
2 tests for categorical variables. 
. Independent samples t tests were conducted to follow up significant main effects. For all analysis of variance tests, effect size was determined by 
2, interpreted as 0.01 = small effect, 0.09 = medium effect, and 0.25 = large effect. A Fisher's exact test was used to compare the percentage of patients in each group who met the 120% RDA per day clinical goal posttreatment. |
RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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Aim 2: Within-Subject Replication
The main effect for energy intake was significant (P = .03; Table 3). No significant differences were observed between baseline and pretreatment (P = .189). After treatment, a significantly higher mean of energy intake per day was reported compared with both baseline (P = .008) and pretreatment (P = .005). The change in energy intake was 892 kcal/day from pre- to posttreatment.
The main effect for percentage of calories from fat was significant (P = .03; Table 3). No significant differences were observed between baseline and pretreatment (P = .556). After treatment, a significantly higher mean of percentage of calories from fat was reported compared with both baseline (P = .005) and pretreatment (P = .05). In terms of RDA per day, 1 (20%) of the 5 children met the 120% goal at pretreatment, and all 5 (100%) met the goal after BEH. This indicates a significant difference in the frequency of participants who met this clinical goal at posttreatment compared with pretreatment (P = .04).
Aim 3: Follow-up
Three-Month Follow-up
Two of the 9 participants who completed the BEH intervention failed to complete the 7-day diet record at the 3-month follow-up assessment. To conduct intention-to-treat analyses, we imputed scores for these 2 participants by calculating the mean change in (1) energy intake per day, (2) percentage of RDA, and (3) percentage of fat intake from posttreatment to 3-month follow-up for the 7 completers. These mean changes then were used to calculate estimated 3- month follow-up data for the 2 noncompleters. The main effect for energy intake was significant (P 
.0001). A significant difference was observed between pre- and posttreatment (P = .001). No significant difference was observed between posttreatment and the 3-month follow-up assessment (P = .249; Table 3), suggesting short-term treatment durability. Similar results were found using 2 other approaches to intention-to-treat analyses: (1) a last value carried forward approach and (2) an imputation method that used the lowest value obtained for a participant who completed the follow-up assessment for the 2 noncompleters.
One (11%) of 9 participants met the 120% or greater RDA per day clinical goal at pretreatment, 9 (100%) of 9 met it at posttreatment, and 8 (89%) of 9 met it at the 3-month follow-up assessment. The main effect for percentage of fat intake was significant (P = .009). Percentage of calories from fat was significantly higher at posttreatment (mean: 38.5; SD: 7.1) compared with pretreatment (mean: 30.7; SD: 8.9; P = .006). No significant difference was observed between posttreatment and the 3-month follow-up assessment (mean: 38.6; SD: 5.9; P = .984). Similar results were found using 2 other approaches to intention-to-treat analyses: (1) a last value carried forward approach and (2) an imputation method that used the lowest value obtained for a participant who completed the follow-up assessment for the 2 noncompleters.
Weight and height assessments were collected at the 3-month follow-up for all 9 participants who completed BEH. Using pretreatment and 3-month follow-up data, we calculated weight and height velocities for 6 months. Clinical benchmarks were based on the 2000 CDC growth charts for a same-aged child who was growing at the 50th percentile (1 kg/6 months and 3.5–4.5 cm/6 months, respectively). The average weight velocity was 1.4 kg (SD: 0.33). Seven of the 9 (78%) participants met the weight velocity benchmark (Fig 2). However, the 2 who did not obtain the goal of 1 kg/6 months were <0.1 kg from this goal. The average height velocity was 5.1 cm (SD: 0.77). All 9 (100%) participants met the minimum benchmark for height velocity; 5 of them exceeded the upper end of the range expected across 6 months (Fig 3).
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One (11%) of the 9 participants met the 120% or greater RDA per day clinical goal at pretreatment, 9 (100%) of 9 met it at posttreatment, and all 9 (100%) again met it at the 12-month follow-up assessment. The main effect for percentage of calories from fat was significant (P = .004). Percentage of calories from fat was significantly higher at posttreatment (mean: 38.5; SD: 7.1) compared with pretreatment (mean: 30.7; SD: 8.9; P = .006). No significant differences were observed between posttreatment and the 12-month follow-up assessment (mean: 34.9; SD: 6.1; P = .089). Similar results were found using 2 other approaches to intention-to-treat analyses: (1) a last value carried forward approach and (2) an imputation method that used the lowest value obtained for a participant who completed the follow-up assessment for the 1 noncompleter.
Weight and height assessments were collected at the 12-month follow-up for all 9 participants who completed BEH. Using posttreatment and 12-month follow-up data, we calculated weight and height velocities for 12 months. Clinical benchmarks were based on the 2000 CDC growth charts for a same-aged child who was growing at the 50th percentile (2 kg/12 months and 7–9 cm/12 months, respectively). The average weight velocity was 2.5 kg (SD: 0.96). Seven of the 9 (78%) participants met the weight velocity benchmark (Fig 4). The 2 children who did not obtain the goal of 2 kg/12 months were within 0.6 and 0.3 kg from this goal, respectively. The average height velocity was 8.3 cm (SD: 1.2). All 9 (100%) of the participants met the minimum benchmark for height velocity (Fig 5).
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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We also found the impact of BEH for toddlers and preschoolers with CF and pancreatic insufficiency to be durable. On returning to usual care, children who received behavioral and nutrition intervention continued to maintain the clinically significant increase in energy intake at 3 and 12 months after treatment. RDA for energy per day and percentage of calories from fat goals were maintained over time, suggesting that families are able to continue to implement the skills and knowledge provided during BEH without ongoing contact with the research team or additional booster treatment sessions. Although a 4-year follow-up study is currently under way to assess further the durability of this early intervention approach to nutritional care for toddlers and preschoolers with CF and pancreatic insufficiency, the demonstration of maintenance of energy intake over a 1-year period suggests that this type of therapy could be a time- and cost-effective approach to early nutrition intervention for young children with CF. Compared with more invasive therapies, such as enteral feeding, that have a greater potential for side effects and complications, the time commitment and cost of BEH is favorable.
The current consensus conference guidelines for pediatric nutrition in CF state that the goal of therapy is normal growth.5 Promising preliminary evidence regarding the impact of BEH on growth in toddlers and preschoolers with CF and pancreatic insufficiency was obtained in this clinical trial. Although the study was not designed to have the statistical power to detect pre- to posttreatment differences in weight and height between the BEH and CTL groups, data from the 3- and 12-month follow-up assessments allowed for comparison of growth velocity obtained by the 9 children who received BEH with a clinical benchmark of normal growth. It is clinically meaningful that the average weight and height velocity over 6-month and 1-year periods for children who received BEH was consistent with growth for children of the same age and gender at the 50th percentile. We will continue to examine rates of weight and height change over time for the children who received BEH in the ongoing 4-year follow-up study. Ultimately, however, future multisite, randomized, controlled clinical trials that can include sample sizes that are sufficient to determine clinically and statistically significant changes in weight and height (eg, age- and gender-specific z scores) will be necessary to confirm that this type of therapy can improve growth in young children with CF and pancreatic insufficiency. Additional considerations for future clinical trials could also enhance the method used in the current study. An attention control condition in which patients receive similar contact with research staff and complete the same number of assessments (eg, diet records) as in the BEH; a between-group research design that tests differences between the BEH and control group over a period >8 weeks; inclusion of methods that allow for additional assessment of the accuracy, reliability, and validity of parent-reported, weighed diet records; determination of energy intake goals that are more individualized to a child's nutritional status and take into account age, gender, and activity level (eg, using dietary reference intake and estimated energy expenditure); and the addition of recently developed and more sensitive measures of lung disease (eg, high-resolution computed tomography of the lung, infant pulmonary function testing) to examine how lung disease status at pretreatment and lung disease progression over time has an impact on and/or is affected by this type of therapy would be important next steps. A multicenter clinical trial that incorporates these enhancements and focuses on the primary endpoint of weight-for-age z score is scheduled to begin by January 2006.
In summary, 3 findings from this clinical trial are noteworthy: (1) the demonstration of the superiority of the BEH to the current standard of care using a randomized design, (2) the replication of the impact of this 8-week therapy with a second sample, and (3) the maintenance of the effects over time without additional intervention beyond standard care. Behavioral and nutrition therapy may fill an important gap regarding early, evidence-based nutritional interventions in CF and lead to advances in the nutritional care of young children with CF and pancreatic insufficiency. Future studies need to focus on 2 complementary objectives: confirmation of the efficacy of behavioral therapy in large, multicenter, randomized clinical trials and development and testing of the effectiveness of this type of therapy under real-world conditions. Indeed, the interdisciplinary care approach of accredited CF centers in the United States is an ideal model for translation of a manualized, evidence-based therapy that produces the recommended levels of energy and fat intake into everyday practice.
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ACKNOWLEDGMENTS |
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We thank staff and colleagues who assisted with patient recruitment, diet record analyses, data management, and biostatistical analyses, including Racquel Henry, Molly Heidemann, Leigh Ann Chamberlin, Suzanne Spang, Dr Susana Patton, Dr Patricia Joseph, Dr Barbara Chini, Dr Jamie Wooldridge, Geri Dinkins, Connie Meeks, Teresa O'Hara, Brook Taylor, Kim Lyons, Terri Schindler, and Dr Judy Bean. We also thank the families who agreed to participate in this research project.
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FOOTNOTES |
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Reprint requests to (S.W.P.) Center for Child Behavior and Nutrition Research, Cincinnati Children's Hospital Medical Center, Division of Behavioral Medicine and Clinical Psychology, MLC: D-3015, 3333 Burnet Ave, Cincinnati, OH 45229-3039. E-mail: Scott.Powers{at}cchmc.org
No conflict of interest declared.
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REFERENCES |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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