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

Primary Purpose

Obesity, Overweight, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fit4Life
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Weight Loss, Obesity, Overweight, Physical Activity, Nutrition, Youth, Adolescent, Technology

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Sites / Locations

  • UCSD, Atkinson Hall, 3rd Floor

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 23, 2010
Last Updated
June 8, 2012
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01171599
Brief Title
PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia
Acronym
PACE-CALL
Official Title
PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a two year study to develop a predominantly web-based behavioral assessment and intervention program (PACE-CALL) that will provide individual assessment and tailoring of a behavioral intervention for adolescent children Acute Lymphoblastic Leukemia (ALL) survivors and their families. In addition, we are conducting formative research to adapt the abovementioned program to children and adolescents aged 7 - 18 who survived any cancer. Focus Groups: Web-Based & Text Message Intervention Feedback Two focus groups will be conducted with adolescent cancer survivors and their families, to assess the usability and acceptability of the web-based intervention, focus groups will be conducted. The two focus groups will last 2 hours with 6-8 people in each group: one focus group with youth & adolescents (age 7 - 18 who are representative of the target population to determine the appropriateness of the web-based intervention one focus group with the parents of the children in the focus group mentioned above (it will occur at the same time). All focus groups will begin with an overview of the study and description of the web-based intervention components. Focus group participants will see sample web pages and may be asked to provide feedback on some or all of the following: Youth, Adolescent or Parent: How does the web-based and text message based intervention address issues faced by children who have survived cancer? What do you like about the web-based intervention? What do you not like about the web-based intervention? What would you change about the web-based intervention? What do you like about the text messages? What do you not like about the text messages? Would you want to join a program like this? Why or why not? If you were to be in this program, how often would you log on to the web-based intervention? How often would you want to receive text messages? What are some of the barriers to joining a program like this?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Weight Loss, Weight Maintenance
Keywords
Weight Loss, Obesity, Overweight, Physical Activity, Nutrition, Youth, Adolescent, Technology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Fit4Life
Intervention Description
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:
Primary Outcome Measure Information:
Title
Acceptability and Usability of a Web & Text Message Based Intervention through Qualitative Feedback from Focus Groups
Description
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.
Time Frame
2-hour focus group

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Have any of the following comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Patrick, MD, MS
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD, Atkinson Hall, 3rd Floor
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0811
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cwphs.ucsd.edu/index.php?option=com_content&view=article&id=51&Itemid=60
Description
Related Info

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

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