PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

January 25, 2016 updated by: Huang, Jeannie, M.D.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: Baseline, 4 months
To determine the impact of a weight loss intervention on BMI compared to a control group
Baseline, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 months
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.
Baseline, 4 months
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
Baseline, 4 months
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.
Baseline, 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huang, Jeannie, M.D.

Collaborators

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 1, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070731

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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