PACE CALL: Weight Loss Study for Childhood Leukemia Survivors
PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJanuary 26, 2016
March 1, 2015
5 years
December 1, 2010
January 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BMI
To determine the impact of a weight loss intervention on BMI compared to a control group
Baseline, 4 months
Secondary Outcomes (4)
Weight Loss Behaviors
Baseline, 4 months
Metabolic Blood Measures
Baseline, 4 months
Psychosocial Mediators of Weight Loss Behaviors
Baseline, 4 months
Quality of Life
Baseline, 4 months
Study Arms (2)
PACE CALL/Fit4Life
EXPERIMENTALFit4Life 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 INTERVENTIONThe Control group will receive monthly mailings on basic nutrition and physical activity information.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huang, Jeannie, M.D.lead
- University of California, San Diegocollaborator
Study Sites (1)
UC San Diego
La Jolla, California, 92093, United States
Related Publications (1)
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.
PMID: 24436138RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 3, 2010
Study Start
June 1, 2008
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
January 26, 2016
Record last verified: 2015-03