PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253720
• Other study ID #: 070731
• Status: Completed
• Phase: N/A
• First received: December 1, 2010
• Last updated: January 25, 2016
• Start date: June 2008
• Est. completion date: June 2013

Study information

• Verified date: March 2015
• Source: Huang, Jeannie, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Cancer
• Leukemia, Lymphoid
• Obesity
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	UC San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Huang, Jeannie, M.D.	University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	To determine the impact of a weight loss intervention on BMI compared to a control group	Baseline, 4 months	No
Secondary	Weight Loss Behaviors	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	No
Secondary	Metabolic Blood Measures	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	No
Secondary	Psychosocial Mediators of Weight Loss Behaviors	To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes	Baseline, 4 months	No
Secondary	Quality of Life	To determine the impace of a weight loss intervention vs. control on quality of life and depression.	Baseline, 4 months	No