Behavioral & Nutritional Treatment to Help CF Preschoolers Grow

NCT ID: NCT00241969

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2015-06-30

Brief Summary

The primary objective of this NIH funded clinical trial is to conduct a multi-center, randomized, controlled trial comparing two interventions: a behavioral plus nutrition intervention to a nutrition intervention. This study will (a) determine the impact of the behavioral intervention on energy intake and weight gain; (b) examine the durability of the behavioral intervention's impact on growth (weight and height) one year following treatment; and (c) explore the relation between physical activity and growth.

Detailed Description

Evidence-based nutritional interventions that achieve and sustain optimal growth in young children with cystic fibrosis (CF) do not exist, despite an urgent need. Such an intervention could positively change the course of clinical lung disease and enhance survival for these children. The primary objective of this NIH funded clinical trial is to conduct a multi-center, randomized, controlled trial comparing two interventions: a behavioral plus nutrition intervention to a nutrition (attention control) intervention. All subjects will receive nutritional care consistent with the 2001 CF Consensus Conference guidelines for pediatric nutrition.

The specific aims are to:

1. determine the impact of the behavioral intervention on energy intake and weight gain;

2. examine the durability of the behavioral intervention's impact on growth (weight and height) one year following treatment; and

3. explore the relation between physical activity and growth. The central hypothesis is that behavioral intervention will lead to better growth as measured by change in weight and height for age z scores.

From three CF Centers in Ohio, (Cincinnati Children's, Columbus Children's, Rainbow Babies and Children's Hospital in Cleveland), two referral centers in Ohio (Dayton Children's and Akron Children's), one CF Center in Michigan (University of Michigan-Ann Arbor), and one CF Center in Arizona (University of Arizona-Tucson), 100 preschoolers with CF and pancreatic insufficiency age 2 to 6 years will be randomized to one of the two conditions. The two groups will be stratified so that they are similar at the initiation of treatment on weight for age z score.

Other critical variables such as history of Pseudomonas aeruginosa infection and gender will be used as covariates in the statistical analysis plan. Outcome data (energy intake measured by 7-day diet record, weight, height) will be obtained at baseline, post-treatment (6 months), and after a 12-month follow-up (18 months post baseline).

Secondary measures will include body mass index, body composition measured by dual energy x-ray absorptiometry (DXA) and skinfolds, and growth velocity. Behavioral treatment will maximize adherence to a high energy diet and enzyme replacement therapy, and motivate children to increase their energy intake. It involves 7 weekly sessions followed by 4 monthly sessions. The attention condition controls for time of contact and number of assessments conducted.

This study advances the investigation of early nutritional interventions for young children with CF and directly addresses the need for controlled, longitudinal assessment of behavioral intervention on growth. The long-range goal is to change the standard of nutritional care for young children with CF because behavioral intervention leads to optimal growth and ultimately improves lung health and survival.

Conditions

Cystic Fibrosis; Pancreatic Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Behavioral and Nutrition Treatment

The behavioral and nutrition treatment combines individualized nutritional counseling that targeted increasing energy and fat intake and parent training in behavioral child-management skills based on social learning theory to improve meal-time behaviors.

Group Type: EXPERIMENTAL

Behavioral and Nutrition Treatment

Intervention Type: BEHAVIORAL

This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills. The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.

Education and Attention Control

The education and attention control treatment provides education and served as a behavioral placebo in terms of controlling for attention and contact frequency provided. Families are provided with information including general nutrition, enzyme therapy, respiratory infection control, and typical child development anticipatory guidance and safety for preschool- aged children.

Group Type: ACTIVE_COMPARATOR

Education and Attention Control

Intervention Type: BEHAVIORAL

This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.

Interventions

Behavioral and Nutrition Treatment

This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills. The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.

Intervention Type: BEHAVIORAL

Education and Attention Control

This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.

Intervention Type: BEHAVIORAL

Other Intervention Names

control arm

Eligibility Criteria

Inclusion Criteria

• confirmed diagnosis of cystic fibrosis based upon 2 of the following: a. sweat chloride by quantitative pilocarpine electrophoresis ≥60 milliequivalent/Liter (mEq/L), b. two clinical features consistent with CF, or c. genetic testing demonstrating two mutations associated with CF
• confirmation of pancreatic insufficiency based upon fecal elastase of ≤ 100 micrograms per gram of stool (or an undetectable level)
• age at enrollment to the trial of 2.0 years to 6.0 years
• at least 6 months post CF diagnosis
• consuming an unrestricted fat diet

Exclusion Criteria

• diagnosis of developmental delay (i.e., autism, cerebral palsy, or mental retardation)
• receiving supplemental enteral nutrition via nasogastric tube, gastrostomy, or total parenteral nutrition
• diagnosed with another disease/condition (e.g., insulin dependent diabetes, congenital heart disease, significant renal disease, history of bowel resection or short bowel syndrome, colonic strictures) known to affect growth
• taking a medication (e.g., insulin, growth hormone, chronic use of systemic steroids) known to affect growth
• screening assessment shows genetic potential for height as acceptable according to the 2001 Consensus Conference guidelines and diet diary indicates daily Dietary Reference Intake (DRI) of energy average of 140% or greater (DRI of 100% will be determined as the estimated energy requirement [EER] based upon the child's age, gender, and an active physical activity level
• weight z score (age and gender adjusted) of > 1.0
• prior participation in the pilot intervention studies conducted by the PI during the prior period of R01 funding or current participation in an intervention trial conducted by the Cystic Fibrosis Therapeutics Development Network.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott W. Powers, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

University of Arizona

Tucson, Arizona, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Rainbows and Babies Children's Hospital

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

Powers SW, Piazza-Waggoner C, Jones JS, Ferguson KS, Daines C, Acton JD. Examining clinical trial results with single-subject analysis: an example involving behavioral and nutrition treatment for young children with cystic fibrosis. J Pediatr Psychol. 2006 Jul;31(6):574-81. doi: 10.1093/jpepsy/jsj049. Epub 2005 Jul 13.

Reference Type: BACKGROUND

PMID: 16014819 (View on PubMed)

Stark LJ, Opipari LC, Jelalian E, Powers SW, Janicke DM, Mulvihill MM, Hovell MF. Child behavior and parent management strategies at mealtimes in families with a school-age child with cystic fibrosis. Health Psychol. 2005 May;24(3):274-80. doi: 10.1037/0278-6133.24.3.274.

Reference Type: BACKGROUND

PMID: 15898863 (View on PubMed)

Powers SW, Patton SR, Rajan S. A comparison of food group variety between toddlers with and without cystic fibrosis. J Hum Nutr Diet. 2004 Dec;17(6):523-7. doi: 10.1111/j.1365-277X.2004.00560.x.

Reference Type: BACKGROUND

PMID: 15546429 (View on PubMed)

Mitchell MJ, Powers SW, Byars KC, Dickstein S, Stark LJ. Family functioning in young children with cystic fibrosis: observations of interactions at mealtime. J Dev Behav Pediatr. 2004 Oct;25(5):335-46. doi: 10.1097/00004703-200410000-00005.

Reference Type: BACKGROUND

PMID: 15502550 (View on PubMed)

Powers SW, Patton SR. A comparison of nutrient intake between infants and toddlers with and without cystic fibrosis. J Am Diet Assoc. 2003 Dec;103(12):1620-5. doi: 10.1016/j.jada.2003.09.024.

Reference Type: BACKGROUND

PMID: 14647088 (View on PubMed)

Powers SW, Patton SR, Byars KC, Mitchell MJ, Jelalian E, Mulvihill MM, Hovell MF, Stark LJ. Caloric intake and eating behavior in infants and toddlers with cystic fibrosis. Pediatrics. 2002 May;109(5):E75-5. doi: 10.1542/peds.109.5.e75.

Reference Type: BACKGROUND

PMID: 11986481 (View on PubMed)

Stark LJ, Jelalian E, Powers SW, Mulvihill MM, Opipari LC, Bowen A, Harwood I, Passero MA, Lapey A, Light M, Hovell MF. Parent and child mealtime behavior in families of children with cystic fibrosis. J Pediatr. 2000 Feb;136(2):195-200. doi: 10.1016/s0022-3476(00)70101-6.

Reference Type: BACKGROUND

PMID: 10657825 (View on PubMed)

Stark LJ, Mulvihill MM, Jelalian E, Bowen AM, Powers SW, Tao S, Creveling S, Passero MA, Harwood I, Light M, Lapey A, Hovell MF. Descriptive analysis of eating behavior in school-age children with cystic fibrosis and healthy control children. Pediatrics. 1997 May;99(5):665-71.

Reference Type: BACKGROUND

PMID: 9113942 (View on PubMed)

Stark LJ, Mulvihill MM, Powers SW, Jelalian E, Keating K, Creveling S, Byrnes-Collins B, Harwood I, Passero MA, Light M, Miller DL, Hovell MF. Behavioral intervention to improve calorie intake of children with cystic fibrosis: treatment versus wait list control. J Pediatr Gastroenterol Nutr. 1996 Apr;22(3):240-53. doi: 10.1097/00005176-199604000-00005.

Reference Type: BACKGROUND

PMID: 8708877 (View on PubMed)

Stark LJ, Jelalian E, Mulvihill MM, Powers SW, Bowen AM, Spieth LE, Keating K, Evans S, Creveling S, Harwood I, et al. Eating in preschool children with cystic fibrosis and healthy peers: behavioral analysis. Pediatrics. 1995 Feb;95(2):210-5.

Reference Type: BACKGROUND

PMID: 7838637 (View on PubMed)

Stark LJ, Powers SW, Jelalian E, Rape RN, Miller DL. Modifying problematic mealtime interactions of children with cystic fibrosis and their parents via behavioral parent training. J Pediatr Psychol. 1994 Dec;19(6):751-68. doi: 10.1093/jpepsy/19.6.751.

Reference Type: BACKGROUND

PMID: 7830215 (View on PubMed)

Stark LJ, Knapp LG, Bowen AM, Powers SW, Jelalian E, Evans S, Passero MA, Mulvihill MM, Hovell M. Increasing calorie consumption in children with cystic fibrosis: replication with 2-year follow-up. J Appl Behav Anal. 1993 Winter;26(4):435-50. doi: 10.1901/jaba.1993.26-435.

Reference Type: BACKGROUND

PMID: 8307828 (View on PubMed)

Powers SW, Stark LJ, Chamberlin LA, Filigno SS, Sullivan SM, Lemanek KL, Butcher JL, Driscoll KA, Daines CL, Brody AS, Schindler T, Konstan MW, McCoy KS, Nasr SZ, Castile RG, Acton JD, Wooldridge JL, Ksenich RA, Szczesniak RD, Rausch JR, Stallings VA, Zemel BS, Clancy JP. Behavioral and nutritional treatment for preschool-aged children with cystic fibrosis: a randomized clinical trial. JAMA Pediatr. 2015 May;169(5):e150636. doi: 10.1001/jamapediatrics.2015.0636. Epub 2015 May 4.

Reference Type: DERIVED

PMID: 25938655 (View on PubMed)

Related Links

http://www.cincinnatichildrens.org/research/div/psychology/faculty-labs/powers/

For more information on research by this team visit:

Other Identifiers

R01DK054915

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK 54915

Identifier Type: -

Identifier Source: org_study_id