Nutrition plays an important role in the management of many chronic illnesses, such as diabetes and cystic fibrosis, and contributes to physical outcomes. Cystic fibrosis (CF) provides an ideal context for evaluating interventions that significantly improve compliance to nutritional treatment, because patients with CF are significantly underweight for age, and nutritional status is strongly correlated with pulmonary functioning, as well as short- and long-term prognosis. Early intervention has been advocated to prevent and/or ameliorate malnutrition in CF, however, few interventions that address these issues have been systematically studied. Behavioral Intervention aimed at modifying problematic parent-child interactions and providing nutritional education has shown promise as an early intervention. Pilot data have demonstrated increased calorie consumption and weight gain in children receiving this intervention (Stark, et al., 1990; Stark et al., 1993). However, a controlled clinical trial has not been conducted with sufficient subjects to compare Behavioral Intervention (with nutrition education) to Nutrition Education alone controlling for time and attention given to participants, and follow-up that assesses the long-term benefits on physiological outcome measures of pulmonary functioning, nutritional status, disease status, and morbidity. The goal of the present study is to conduct such a comparison. A multi-site design will allow for the recruitment of 84 children with CF and their parents to participate in either a Behavioral Intervention or a Nutrition Education group, with matching on weight percentile and disease status. Both treatments will be conducted in a group format with equal time and attention given to participants in each. Data will be collected on calorie intake; measures of weight, height, tricep skinfold, and body fat; physiological measures of pulmonary functioning, NIH score of disease severity, and nutritional status; and on behavioral measures of parent-child interaction at meals, parent coping, and family stress from pre- to post-treatment and at 6 month intervals for two years following treatment. The specific hypotheses are: 1) the Behavioral Intervention will demonstrate significantly greater increase in children's calorie consumption and weight than Nutrition Education alone; 2) participants in the Behavioral Intervention will show significantly greater improvement on behavioral measures of parent-child interactions at meals, improved coping and decreased family stress pre- to post-treatment and at the follow-ups than participants in the Nutrition Education group; and 3) the Behavioral Intervention will result in significantly greater improvements in physiological status as indicated by pulmonary functioning, NIH score of disease severity, and school attendance than the Nutrition Education group pretreatment to the 12- and 24-month follow-up.
| Stark, Lori J; Opipari-Arrigan, Lisa; Quittner, Alexandra L et al. (2011) The effects of an intensive behavior and nutrition intervention compared to standard of care on weight outcomes in CF. Pediatr Pulmonol 46:31-5 |
| Opipari-Arrigan, Lisa; Powers, Scott W; Quittner, Alexandra L et al. (2010) Mealtime problems predict outcome in clinical trial to improve nutrition in children with CF. Pediatr Pulmonol 45:78-82 |
| Stark, Lori J; Quittner, Alexandra L; Powers, Scott W et al. (2009) Randomized clinical trial of behavioral intervention and nutrition education to improve caloric intake and weight in children with cystic fibrosis. Arch Pediatr Adolesc Med 163:915-21 |
| Spieth, L E; Stark, L J; Mitchell, M J et al. (2001) Observational assessment of family functioning at mealtime in preschool children with cystic fibrosis. J Pediatr Psychol 26:215-24 |
