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PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01253720
Enrollment
38
Registered
2010-12-03
Start date
2008-06-30
Completion date
2013-06-30
Last updated
2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Cancer, Obesity

Keywords

obesity, text messages, internet, cancer, overweight

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.

Interventions

BEHAVIORALPACE CALL/Fit4Life

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

Sponsors

University of California, San Diego
CollaboratorOTHER
Huang, Jeannie, M.D.
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BMIBaseline, 4 monthsTo determine the impact of a weight loss intervention on BMI compared to a control group

Secondary

MeasureTime frameDescription
Weight Loss BehaviorsBaseline, 4 monthsTo determine the impact of a weight loss intervention vs. a control group on self-reported behavioral measures of diet and physical activity.
Metabolic Blood MeasuresBaseline, 4 monthsTo determine the impact of a weight loss intervention vs. control on fasting serum insulin, fasting blood glucose, and blood lipid levels.
Psychosocial Mediators of Weight Loss BehaviorsBaseline, 4 monthsTo determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes
Quality of LifeBaseline, 4 monthsTo determine the impace of a weight loss intervention vs. control on quality of life and depression.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026