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Completed

NCT Number: NCT01253720

PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PACE CALL/Fit4Life

Behavioral

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 outcomes

  1. BMI

    Time frame: Baseline, 4 months

    To determine the impact of a weight loss intervention on BMI compared to a control group

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Huang, Jeannie, M.D.

Indiv

Collaborators

  • University of California, San Diego

Registry information

Official study title

PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 3, 2010
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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