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
  Purpose

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.


Condition Intervention
Acute Lymphoblastic Leukemia
Cancer
Obesity
Behavioral: PACE CALL/Fit4Life

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors

Resource links provided by NLM:


Further study details as provided by Huang, Jeannie, M.D.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 38
Study Start Date: June 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253720

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

No publications provided by Huang, Jeannie, M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Huang, Jeannie, M.D.
ClinicalTrials.gov Identifier: NCT01253720     History of Changes
Other Study ID Numbers: 070731
Study First Received: December 1, 2010
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Huang, Jeannie, M.D.:
obesity
text messages
internet
cancer
overweight

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Obesity
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014