PACE CALL: Weight Loss Study for Childhood Leukemia Survivors
|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|
- 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
- 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.
|Study Start Date:||June 2008|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253720
|United States, California|
|UC San Diego|
|La Jolla, California, United States, 92093|