Acute Lymphoblastic LeukemiaNCT01253720
PACE CALL: Weight Loss Study for Childhood Leukemia Survivors
A study testing PACE CALL/Fit4Life in people with Acute Lymphoblastic Leukemia and Cancer, run by Huang, Jeannie, M.D. at 1 site in United States.
Trial summary
UC San Diego researchers conducted a study to develop and evaluate an internet and text message based weight loss study 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
- Acute Lymphoblastic Leukemia, Cancer, Obesity
- What is being tested?
- PACE CALL/Fit4Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2013
- 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
- 7 - 18 years old
- survived childhood acute lymphoblastic leukemia (defined as being off treatment for at least 2 years)
- greater than or equal to 85th percentile BMI-for-age and gender)
- read and speak English
- have a parent that reads and speaks English or Spanish
- willingness to attend assessments
- access to the Internet
Who cannot join
- any comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
- any subject with a known disease of the liver, pancreas or small intestine that would adversely effect digestion or absorption of nutrients
- any pulmonary, cardiovascular, orthopedic, or musculoskeletal problem that would limit ability to adhere to moderate-level physical activity recommendations
- have a history of substance abuse or other psychiatric disorder that would impair compliance with the study protocol
- are using any medications which alter body weight
- are currently enrolled in another weight loss program
- in foster care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors
UC San Diego researchers conducted a study to develop and evaluate an internet and text message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors. We hypothesized that those study participants randomized to the intervention will demonstrate greater reduction in BMI-z score as compared to the control group.
Read the detailed description
The PACE CALL or Fit4Life study, sponsored by the American Cancer Society , was a 4-year research project aimed at developing and testing the efficacy of a web \& cell phone based weight loss program. The purpose of the intervention was to promote weight loss and management and improve physical activity, diet and sedentary behaviors among preadolescent and adolescent youth (7-18) who are survivors of childhood ALL (defined as being off therapy for at least 2 years without disease relapse). Fit4Life was based on and adapted from notable prior successful adolescent weight control interventions, and physical activity and diet behavioral promotion interventions in the preadolescent and adolescent age group. Particular sensitivity to issues experienced by cancer survivors and their families were incorporated into this newly developed intervention based on systematic cancer survivor input and feedback as well as mentor/collaborator input regarding cancer survivor research.
- Conditions
- Acute Lymphoblastic Leukemia, Cancer, Obesity
- Being tested
- PACE CALL/Fit4Life
- Keywords
- obesity, text messages, internet, cancer, overweight
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACE CALL/Fit4LifeBehavioural
The Fit4Life E intervention will be designed to promote weight loss and subsequent weight loss maintenance through the adoption and maintenance of improved eating, physical activity and sedentary behaviors in at risk for overweight and overweight adolescent survivors of ALL and their parent/guardian. the Fit4Life intervention will incorporate elements of the Chronic Care Model, including frequent phone and mail interactions, an initial in-person encounter to provide encouragement and initial patient-tailored counseling for obesity management, family-centered skill development to achieve healthy behavioral modification via goal setting, self-monitoring, and problem solving.
The Fit4Life intervention includes:
Web-based weight loss program Text and Picture messages Counseling Calls Health Coach
| Study group | Role | What they receive |
|---|---|---|
| PACE CALL/Fit4Life | Experimental | Fit4Life intervention activities:
Website: Provides weekly nutrition, physical activity, and weight loss information.
Counseling Calls: Participants and their parents will get phone calls from their Health Coach to assess progress \& problems.
Health Coach Question \& Answer: Participants will be assigned a Health Coach that they can contact at any time to ask questions or express any concerns.
Text \& Picture Messages: Participants will receive daily text messages to help remind them of being healthy. Messages will relate to the weekly topics and general checking in questions.
Parent Materials: Parents will receive a packet of printed materials that relate to parenting skills regarding being a healthy role model for their child and healthy eating and exercise tips. Receives: Behavioral: PACE CALL/Fit4Life |
| Control | No intervention | The Control group will receive monthly mailings on basic nutrition and physical activity information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
To determine the impact of a weight loss intervention on BMI compared to a control group
Measured: Baseline, 4 months
Secondary outcomes (4)
Weight Loss Behaviors
To determine the impact of a weight loss intervention vs. a control group on self-reported behavioral measures of diet and physical activity.
Measured: Baseline, 4 months
Metabolic Blood Measures
To determine the impact of a weight loss intervention vs. control on fasting serum insulin, fasting blood glucose, and blood lipid levels.
Measured: Baseline, 4 months
Psychosocial Mediators of Weight Loss Behaviors
To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes
Measured: Baseline, 4 months
Quality of Life
To determine the impace of a weight loss intervention vs. control on quality of life and depression.
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huang, Jeannie, M.D.
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253720
- Sponsor's protocol ID
- 070731
- Status last verified
- Mar 2015
- First submitted
- 1 Dec 2010
- Last updated
- 26 Jan 2016
- Results posted
- No
Publications
Huang JS, Dillon L, Terrones L, Schubert L, Roberts W, Finklestein J, Swartz MC, Norman GJ, Patrick K. Fit4Life: a weight loss intervention for children who have survived childhood leukemia. Pediatr Blood Cancer. 2014 May;61(5):894-900. doi: 10.1002/pbc.24937. Epub 2014 Jan 16.
PubMed 24436138
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors
- ClinicalTrials.gov ID
- NCT01253720
- Acronym / sponsor ID
- 070731
- Conditions
- Acute Lymphoblastic Leukemia, Cancer, Obesity
- Keywords
- obesity, text messages, internet, cancer, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Huang, Jeannie, M.D.
- Collaborators
- University of California, San Diego
- Study start
- Jun 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Dec 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.
UC San Diego researchers conducted a study to develop and evaluate an internet and text message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors. We hypothesized that those study participants randomized to the intervention will demonstrate greater reduction in BMI-z score as compared to the control group.
Detailed description
The PACE CALL or Fit4Life study, sponsored by the American Cancer Society , was a 4-year research project aimed at developing and testing the efficacy of a web \& cell phone based weight loss program. The purpose of the intervention was to promote weight loss and management and improve physical activity, diet and sedentary behaviors among preadolescent and adolescent youth (7-18) who are survivors of childhood ALL (defined as being off therapy for at least 2 years without disease relapse). Fit4Life was based on and adapted from notable prior successful adolescent weight control interventions, and physical activity and diet behavioral promotion interventions in the preadolescent and adolescent age group. Particular sensitivity to issues experienced by cancer survivors and their families were incorporated into this newly developed intervention based on systematic cancer survivor input and feedback as well as mentor/collaborator input regarding cancer survivor research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACE CALL/Fit4Life | Experimental | Behavioral: PACE CALL/Fit4LifeFit4Life intervention activities: Website: Provides weekly nutrition, physical activity, and weight loss information. Counseling Calls: Participants and their parents will get phone calls from their Health Coach to assess progress \& problems. Health Coach Question \& Answer: Participants will be assigned a Health Coach that they can contact at any time to ask questions or express any concerns. Text \& Picture Messages: Participants will receive daily text messages to help remind them of being healthy. Messages will relate to the weekly topics and general checking in questions. Parent Materials: Parents will receive a packet of printed materials that relate to parenting skills regarding being a healthy role model for their child and healthy eating and exercise tips. |
| Control | No intervention | –The Control group will receive monthly mailings on basic nutrition and physical activity information. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 7 - 18 years old
- survived childhood acute lymphoblastic leukemia (defined as being off treatment for at least 2 years)
- greater than or equal to 85th percentile BMI-for-age and gender)
- read and speak English
- have a parent that reads and speaks English or Spanish
Key exclusion criteria (7 listed)
- any comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
- any subject with a known disease of the liver, pancreas or small intestine that would adversely effect digestion or absorption of nutrients
- any pulmonary, cardiovascular, orthopedic, or musculoskeletal problem that would limit ability to adhere to moderate-level physical activity recommendations
- have a history of substance abuse or other psychiatric disorder that would impair compliance with the study protocol
- are using any medications which alter body weight
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 |
|---|---|---|
| PACE CALL/Fit4LifeThe Fit4Life E intervention will be designed to promote weight loss and subsequent weight loss maintenance through the adoption and maintenance of improved eating, physical activity and sedentary behaviors in at risk for overweight and overweight adolescent survivors of ALL and their parent/guardian. the Fit4Life intervention will incorporate elements of the Chronic Care Model, including frequent phone and mail interactions, an initial in-person encounter to provide encouragement and initial patient-tailored counseling for obesity management, family-centered skill development to achieve healthy behavioral modification via goal setting, self-monitoring, and problem solving. The Fit4Life intervention includes: Web-based weight loss program Text and Picture messages Counseling Calls Health Coach | Behavioural | PACE CALL/Fit4Life |
Primary outcome
BMI
Time frame: Baseline, 4 months
To determine the impact of a weight loss intervention on BMI compared to a control group
4 secondary outcomes
Weight Loss Behaviors
Time frame: Baseline, 4 months
Metabolic Blood Measures
Time frame: Baseline, 4 months
Psychosocial Mediators of Weight Loss Behaviors
Time frame: Baseline, 4 months
Quality of Life
Time frame: Baseline, 4 months
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 26 Jan 2016.
- Results publication: PubMed 24436138Huang JS, Dillon L, Terrones L, Schubert L, Roberts W, Finklestein J, Swartz MC, Norman GJ, Patrick K. Fit4Life: a weight loss intervention for children who have survived childhood leukemia. Pediatr Blood Cancer. 2014 May;61(5):894-900. doi: 10.1002/pbc.24937. Epub 2014 Jan 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACE CALL/Fit4Life in people with Acute Lymphoblastic Leukemia and Cancer, run by Huang, Jeannie, M.D. 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 7 inclusion and 7 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 26 Jan 2016. 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?
BMI (time frame: Baseline, 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01253720, which also lists 1 linked publication.
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 26 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.