PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

University of California, San Diego

Information provided by (Responsible Party):

Huang, Jeannie, M.D.

ClinicalTrials.gov Identifier:

NCT01253720

First received: December 1, 2010

Last updated: May 10, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 1, 2010
Last Updated Date	May 10, 2013
Start Date ^ICMJE	June 2008
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 2, 2010)	BMI [ Time Frame: Baseline, 4 months ] [ Designated as safety issue: No ] To determine the impact of a weight loss intervention on BMI compared to a control group
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01253720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 2, 2010)	Weight Loss Behaviors [ Time Frame: Baseline, 4 months ] [ Designated as safety issue: No ] 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 [ Time Frame: Baseline, 4 months ] [ Designated as safety issue: No ] 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 [ Time Frame: Baseline, 4 months ] [ Designated as safety issue: No ] To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes Quality of Life [ Time Frame: Baseline, 4 months ] [ Designated as safety issue: No ] To determine the impace of a weight loss intervention vs. control on quality of life and depression.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PACE CALL: Weight Loss Study for Childhood Leukemia Survivors
Official Title ^ICMJE	PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors
Brief Summary	UC San Diego researchers are conducting a study to develop and evaluate an internet and text message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors. We hypothesize 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 , 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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Acute Lymphoblastic Leukemia Cancer Obesity
Intervention ^ICMJE	Behavioral: PACE 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
Study Arm (s)	Experimental: 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. Intervention: Behavioral: PACE CALL/Fit4Life No Intervention: Control The Control group will receive monthly mailings on basic nutrition and physical activity information.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	38
Estimated Completion Date	June 2013
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	7 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01253720
Other Study ID Numbers ^ICMJE	070731
Has Data Monitoring Committee	Not Provided
Responsible Party	Huang, Jeannie, M.D.
Study Sponsor ^ICMJE	Huang, Jeannie, M.D.
Collaborators ^ICMJE	University of California, San Diego
Investigators ^ICMJE	Not Provided
Information Provided By	Huang, Jeannie, M.D.
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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