PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

Not Applicable

Completed

• Conditions: Cancer; Acute Lymphoblastic Leukemia; Obesity
• Interventions: Behavioral: PACE CALL/Fit4Life

• Registration Number: NCT01253720
• Lead Sponsor: Huang, Jeannie, M.D.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-03
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PACE CALL/Fit4Life	PACE CALL/Fit4Life	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.

Primary Outcome Measures

Name	Time	Method
BMI	Baseline, 4 months	To determine the impact of a weight loss intervention on BMI compared to a control group

Secondary Outcome Measures

Name	Time	Method
Metabolic Blood Measures	Baseline, 4 months	To 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 Behaviors	Baseline, 4 months	To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes
Weight Loss Behaviors	Baseline, 4 months	To determine the impact of a weight loss intervention vs. a control group on self-reported behavioral measures of diet and physical activity.
Quality of Life	Baseline, 4 months	To determine the impace of a weight loss intervention vs. control on quality of life and depression.

Trial Locations

Locations (1)

UC San Diego; 🇺🇸 La Jolla, California, United States