PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia

NCT01171599 | Completed

• 1 other identifier: R21CA128019
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this National Cancer Institute (NCI) funded study is to develop and test the acceptability and usability of a web \& text message based weight loss intervention for childhood acute lymphoblastic leukemia (ALL) survivors. Childhood cancer survivors ages 7 - 18 will provide feedback during focus groups on a web and text message based program that was developed.

Conditions

Obesity; Overweight; Weight Loss; Weight Maintenance

Keywords

Weight Loss; Obesity; Overweight; Physical Activity; Nutrition; Youth; Adolescent; Technology

Outcome Measures

Primary Outcomes (1)

• Acceptability and Usability of a Web & Text Message Based Intervention through Qualitative Feedback from Focus Groups

  The primary outcome is to develop a web and text message based weight loss intervention that will provide individual assessment and tailoring of a behavioral intervention for ALL survivors. In order to test the acceptaibility and usability of the website and text message program, focus groups will be conducted with cancer survivors to provide feedback on the program.

  2-hour focus group

Interventions

Fit4Life BEHAVIORAL

As previously described, the purpose of this study is to develop a web and text message based weight loss intervention for childhood acute lymphoblastic leukemia survivors (ALL) survivor. The web and text message based intervention that is being developed will be evaluated in a separate ACS (American Cancer Society) funded trial randomized control trial. The web and text message based intervention (there are other intervention features that do not relate to the web \& text based platforms that were developed as part of this NIH funded study) is a 16-week program that includes:

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Are 7 - 18 years
• Provide assent and have a legal guardian that will participate and provide parental permission/consent
• Are a cancer survivor (off treatment for two years)
• Are overweight or obese (85th percentile BMI (Body Mass Index) for age and gender)

You may not qualify if:

• Have any of the following comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD, Atkinson Hall, 3rd Floor

La Jolla, California, 92037-0811, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Kevin Patrick, MD, MS

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 28, 2010
• Study Start: August 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 11, 2012

Record last verified: 2012-06

Locations

US (1)