Back to resultsPACE CALL: Weight Loss Study for Childhood Leukemia Survivors
Primary Purpose
Acute Lymphoblastic Leukemia, Cancer, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PACE CALL/Fit4Life
Sponsored by
About this trial
This is an interventional prevention trial for Acute Lymphoblastic Leukemia focused on measuring obesity, text messages, internet, cancer, overweight
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
Sites / Locations
- UC San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PACE CALL/Fit4Life
Control
Arm Description
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.
The Control group will receive monthly mailings on basic nutrition and physical activity information.
Outcomes
Primary Outcome Measures
BMI
To determine the impact of a weight loss intervention on BMI compared to a control group
Secondary Outcome Measures
Weight Loss Behaviors
To determine the impact of a weight loss intervention vs. a control group on self-reported behavioral measures of diet and physical activity.
Metabolic Blood Measures
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
To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes
Quality of Life
To determine the impace of a weight loss intervention vs. control on quality of life and depression.
Full Information
NCT ID
NCT01253720
First Posted
December 1, 2010
Last Updated
January 25, 2016
Sponsor
Huang, Jeannie, M.D.
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01253720
Brief Title
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huang, Jeannie, M.D.
Collaborators
University of California, San Diego
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Cancer, Obesity
Keywords
obesity, text messages, internet, cancer, overweight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PACE CALL/Fit4Life
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The Control group will receive monthly mailings on basic nutrition and physical activity information.
Intervention Type
Behavioral
Intervention Name(s)
PACE CALL/Fit4Life
Intervention Description
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
Primary Outcome Measure Information:
Title
BMI
Description
To determine the impact of a weight loss intervention on BMI compared to a control group
Time Frame
Baseline, 4 months
Secondary Outcome Measure Information:
Title
Weight Loss Behaviors
Description
To determine the impact of a weight loss intervention vs. a control group on self-reported behavioral measures of diet and physical activity.
Time Frame
Baseline, 4 months
Title
Metabolic Blood Measures
Description
To determine the impact of a weight loss intervention vs. control on fasting serum insulin, fasting blood glucose, and blood lipid levels.
Time Frame
Baseline, 4 months
Title
Psychosocial Mediators of Weight Loss Behaviors
Description
To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes
Time Frame
Baseline, 4 months
Title
Quality of Life
Description
To determine the impace of a weight loss intervention vs. control on quality of life and depression.
Time Frame
Baseline, 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24436138
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.
Results Reference
result
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PACE CALL: Weight Loss Study for Childhood Leukemia Survivors
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