Powers Lab

Study Status: Closed to enrollment

The objective of this study is to conduct a multicenter, randomized, controlled clinical trial comparing behavioral plus nutrition intervention (BEH) to standard nutritional care with attention control (ATT). The specific aims are to determine the impact of BEH on energy intake and weight gain, examine the durability of BEH’s impact on growth (weight and height) one year following treatment, and identify associations between growth and indicators of lung disease.  The centers participating are all accredited CF Centers (Cincinnati Children’s, Nationwide Children’s Hospital in Columbus Rainbow Babies & Children’s Hospital in Cleveland, University of Michigan Health System in Ann Arbor and University of Arizona Respiratory Center in Tucson, as well as CF centers in Dayton and Akron serving as referral sites).
 

One hundred preschoolers with CF and pancreatic insufficiency age 2 to 6 years will be randomized to one of the two conditions. Both groups will meet individually with research staff for seven weekly sessions followed by four monthly sessions. BEH will maximize adherence to a high-energy diet and enzyme replacement therapy, and motivate children to increase their energy intake. Behavioral strategies for setting intake goals as well as child behavior management will be incorporated into these BEH sessions. ATT will provide developmental anticipatory guidance information to families. While nutrition information will be discussed with these families, they will not receive the behavioral aspects of the intervention provided in BEH.
 

Funded by:
National Institutes of Health − National Institute of Diabetes and Digestive and Kidney Diseases, R01 DK54915-06A1.

Study Status: Closed to enrollment

This is a substudy to the larger “Behavioral and Nutrition Treatment to Help Preschoolers with CF Grow” clinical trial.  A subset of preschoolers in Cincinnati and Columbus will have an HRCT of their lungs conducted at the baseline and 12-month follow-up assessments (18 months in total).  These data will allow for a determination of the child’s lung disease status at the initiation of the clinical trial and a determination of the child’s lung disease progression (i.e., change in HRCT scores) over the 18-month period from pretreatment to follow-up. The long-range goal is to follow this cohort of children over time to track the impact of early and effective nutritional treatment on the CF disease process during childhood and adolescence.  A rigorous assessment of lung disease status during this clinical trial is necessary for success in meeting this goal.

Funded by:
Cystic Fibrosis Foundation

Study Status: Closed to enrollment

This study focuses on the effectiveness of a treatment booster study designed to assist families in maintaining and / or re-establishing positive changes in energy intake and growth. The booster sessions are designed to address the unique developmental regimen management, behavioral, and nutritional needs for each family. We are obtaining growth and energy intake data at regular intervals through adolescence to better understand the long-term impact on growth of receiving a behavioral and nutrition treatment as toddlers along with booster treatment sessions more than four years later.

Funded by:
National Institutes of Health − National Institute of Diabetes and Digestive and Kidney Diseases, K24 DK059973.

Manuscripts are currently in preparation for two projects.  The first describes four-year post-treatment energy intake and growth outcomes for a cohort of toddlers with CF whose parents participated in an eight-week behavior-nutrition treatment.
 

The second manuscript describes qualitative thematic data from parent interviews. The parent interviews focused on what parents recalled about the behavioral treatment and what challenges their families encountered as their children grew from toddlers to school-age children. Data are currently being collected to assess the effectiveness of booster behavior-nutrition treatment sessions on energy intake and growth.
 

Stephanie Spear Filigno and Scott Powers are also collaborating with Lori Stark on translating the face-to-face behavior nutrition treatment into a web-based format. This website will allow families that do not have the ability to travel to their CF center greater access to this treatment through the use of technology.