PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

NCT ID: NCT01253720

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Acute Lymphoblastic Leukemia; Cancer; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PACE CALL/Fit4Life

Intervention Type: 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

Control

The Control group will receive monthly mailings on basic nutrition and physical activity information.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

Huang, Jeannie, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UC San Diego

La Jolla, California, United States

Countries

United States

References

Huang JS, Dillon L, Terrones L, Schubert L, Roberts W, Finklestein J, Swartz MC, Norman GJ, Patrick K. Fit4Life: a weight loss intervention for children who have survived childhood leukemia. Pediatr Blood Cancer. 2014 May;61(5):894-900. doi: 10.1002/pbc.24937. Epub 2014 Jan 16.

Reference Type: RESULT

PMID: 24436138 (View on PubMed)

Other Identifiers

070731

Identifier Type: -

Identifier Source: org_study_id