Clinical trial NCT01253720: PACE CALL: Weight Loss Study for Childhood Leukemia Survivors
Official title: PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Cancer
Obesity
Keywords: obesity
text messages
internet
cancer
overweight
Lead sponsor: Huang, Jeannie, M.D.
Sponsor class: INDIV
Collaborators: name: University of California, San Diego
First posted: 2010-12-03
Enrollment: 38
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: BMI
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Weight Loss Behaviors
timeFrame: Baseline, 4 months
measure: Metabolic Blood Measures
timeFrame: Baseline, 4 months
measure: Psychosocial Mediators of Weight Loss Behaviors
timeFrame: Baseline, 4 months
measure: Quality of Life
timeFrame: Baseline, 4 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
References:
citation: 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.