ObesityPACE-CALLNCT01171599
PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia
A study testing Fit4Life in people with Obesity and Overweight, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Fit4Life
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Have any of the following comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD, Atkinson Hall, 3rd Floor
La Jolla, California, 92037-0811
About this study
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.
Read the 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?
- Conditions
- Obesity, Overweight, Weight Loss, Weight Maintenance
- Being tested
- Fit4Life
- Keywords
- Weight Loss, Obesity, Overweight, Physical Activity, Nutrition, Youth, Adolescent, Technology
- Medical subject headings
- Obesity, Overweight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit4LifeBehavioural
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:
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-hour focus group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startAug 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Kevin Patrick, MD, MS, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171599
- Sponsor's protocol ID
- R21CA128019
- Acronym
- PACE-CALL
- Status last verified
- Jun 2012
- First submitted
- 23 Jul 2010
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia
- ClinicalTrials.gov ID
- NCT01171599
- Acronym / sponsor ID
- PACE-CALL / R21CA128019
- Conditions
- Obesity, Overweight, Weight Loss, Weight Maintenance
- Keywords
- Weight Loss, Obesity, Overweight, Physical Activity, Nutrition, Youth, Adolescent, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Have any of the following comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fit4LifeAs 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: | Behavioural | – |
Primary outcome
Acceptability and Usability of a Web & Text Message Based Intervention through Qualitative Feedback from Focus Groups
Time frame: 2-hour focus group
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Patrick, MD, MS principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit4Life in people with Obesity and Overweight, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and Usability of a Web & Text Message Based Intervention through Qualitative Feedback from Focus Groups (time frame: 2-hour focus group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.