PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01253720
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : January 26, 2016
University of California, San Diego
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Cancer Obesity Behavioral: PACE CALL/Fit4Life Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors
Study Start Date : June 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
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.

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

No Intervention: Control
The Control group will receive monthly mailings on basic nutrition and physical activity information.

Primary Outcome Measures :
  1. BMI [ Time Frame: Baseline, 4 months ]
    To determine the impact of a weight loss intervention on BMI compared to a control group

Secondary Outcome Measures :
  1. Weight Loss Behaviors [ Time Frame: 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.

  2. Metabolic Blood Measures [ Time Frame: 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.

  3. Psychosocial Mediators of Weight Loss Behaviors [ Time Frame: Baseline, 4 months ]
    To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes

  4. Quality of Life [ Time Frame: Baseline, 4 months ]
    To determine the impace of a weight loss intervention vs. control on quality of life and depression.

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01253720

United States, California
UC San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
Huang, Jeannie, M.D.
University of California, San Diego

Publications of Results:
Responsible Party: Huang, Jeannie, M.D. Identifier: NCT01253720     History of Changes
Other Study ID Numbers: 070731
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: March 2015

Keywords provided by Huang, Jeannie, M.D.:
text messages

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases