Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis (Be In Charge)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01686672
First received: September 13, 2012
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

This study will demonstrate feasibility and collect pilot data via a pilot randomized trial of 20 participants on the effectiveness of a web-based delivery system of behavioral plus nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years of age that has been found to be efficacious in face to face delivery.


Condition Intervention
Cystic Fibrosis
Behavioral: Web Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Change in Average Daily Caloric Intake [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    Change in average daily caloric intake at baseline and 10 weeks.


Secondary Outcome Measures:
  • Change in Weight [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    Change in weight from baseline to 10 weeks


Other Outcome Measures:
  • Use of web-based intervention [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Ongoing use of web-intervention collected electronically via the web to include sign on, duration of time on web, page views, and completion of activities on the web-site

  • Treatment Satisfaction [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Assessment of participant's satisfaction with the intervention and web-site


Enrollment: 12
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Web Intervention
BeInCharge has two components: an electronic diet tracker and a 7 session intervention. The 7 treatment sessions are designed to be completed over a 7 to 10 week period. Each treatment module includes both a nutrition education and child behavior management component. Treatment sessions should be completed every 7 to 10 days, while the electronic diet tracker requires daily input.
Behavioral: Web Intervention
Behavioral
Other Name: Be In Charge
No Intervention: Usual Care
Participants will receive usual care and be assessed at baseline and week 10 for study outcomes.

Detailed Description:

Optimizing nutritional status and growth improves health outcomes and survival in children with cystic fibrosis (CF). Better pulmonary function, as measured by forced expiratory rate in 1 second (FEV1), is associated with body mass index (BMI) above the 50th percentile for age and gender for children with CF1. Evidence based practice guidelines recommend that nutritional treatment for children with CF ages 2 to 20 years should aim to achieve and maintain a BMI > 50th percentile, however across 117 CF centers in the United States 57% of girls and 56% of boys failed to meet this recommendation1. The investigators have developed a highly effective behavioral plus nutrition intervention (BE IN CHARGE) and demonstrated its efficacy when delivered face-to-face to produce weight gain and its superiority over nutrition education alone. Although endorsed by the CF Foundation as an evidence-based treatment, it is not available to most CF Centers or families due to lack of trained personnel, cost, and distance issues. With funding from the CF Foundation the investigators developed a web-based delivery system of their efficacious behavioral plus nutrition intervention for parents of children with CF ages 4 to 9 years of age. Using a Place Outcomes Award the investigators have conducted beta testing of the web-intervention and made appropriate modifications. The current study represents the next steps in refining and testing our web-based intervention. This study will demonstrate feasibility and collect pilot data on the effectiveness of the intervention in a pilot randomized trial of 20 treatment naïve participants.

  Eligibility

Ages Eligible for Study:   4 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Cystic Fibrosis
  • Ages 4 to 9 year
  • below the 50th percentile for body mass index for age and gender
  • and their parents

Exclusion Criteria:

  • medical condition that would affect diet or growth (e.g., type 1 diabetes mellitus)
  • significant developmental delays
  • a sputum culture positive for Burkholderia cepacia
  • a forced expiratory volume in the first second of expiration (FEV1) of less than 40%
  • receiving enteral or parenteral nutrition.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686672

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45239
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Lori Stark, Ph.D. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01686672     History of Changes
Other Study ID Numbers: 2012-0467
Study First Received: September 13, 2012
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Cystic Fibrosis
Behavioral Intervention
Children

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014