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PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors


N/A
7 Years
18 Years
Open (Enrolling by invite only)
Both
Acute Lymphoblastic Leukemia, Cancer, Obesity

Thank you

Trial Information

PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors


The PACE CALL or Fit4Life study, sponsored by the American Cancer Society , is 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 is 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 will be 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 will be
incorporated into this newly developed intervention based on systematic cancer survivor
input and feedback as well as mentor/collaborator input regarding cancer survivor research.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

BMI

Outcome Description:

To determine the impact of a weight loss intervention on BMI compared to a control group

Outcome Time Frame:

Baseline, 4 months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

070731

NCT ID:

NCT01253720

Start Date:

June 2008

Completion Date:

June 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Cancer
  • Obesity
  • obesity
  • text messages
  • internet
  • cancer
  • overweight
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Obesity

Name

Location

UC San Diego La Jolla, California  92093