Mila Blooms Intervention Study
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
|Official Title:||Mila Blooms Intervention Study: An App for Promoting Physical Activity and Health Diet Among Adolescent Survivors of Childhood Cancer|
- Feasibility of the Mila Blooms Intervention at changing health behaviors. [ Time Frame: ~9 weeks (from pre-intervention baseline to post-intervention follow-up) ]Test the feasibility of the Mila Blooms intervention at changing diet, physical activity, body mass index (BMI), and social cognitive mediators of health behavior change.
|Study Start Date:||April 2011|
|Study Completion Date:||July 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Control & Intervention Phases
The control phase will run for 8 weeks, including survey completion and accelerometer wear during Week 1 and Week 8. The intervention phase will run for the 9 weeks following the control phase; where participants are assigned a smartphone to interact with the Mila Blooms gaming app and integrated social network & receive weekly supportive coaching phone calls from study staff for 8 weeks (Week 9 - Week 16) followed by accelerometer wear & survey completion during the 9th and final week (Week 17).
Behavioral: Mila Blooms
Behavioral intervention will be administered to 30 adolescent childhood cancer survivors & their parents (3 blocks of 10 survivor-parent(s) groups) who serve as their own controls. The intervention phase begins at Week 9 (immediately following the 8-week control phase) and runs for 9 weeks (Weeks 9 - 17). Adolescents are assigned a smartphone installed with the Mila Blooms app to use for the first 8 weeks (Weeks 9 - 16) of the intervention. The app integrates (1) tools for tracking health behaviors (e.g., diet, physical activity, etc.); (2) an avatar system to provide virtual rewards, and (3) a social network of users for support. As part of the intervention, adolescents will also receive weekly coaching phone calls from study staff to discuss areas of concern and to encourage goal-setting & participation. During the 9th week (Week 17), participants complete one final survey & accelerometer wear.
While successful advancements in treatment for childhood Acute Lymphoblastic Leukemia (ALL) have resulted in a growing cohort of survivors, these survivors are at risk for a number of long-term health problems. This study proposes to develop and conduct feasibility testing for a smartphone application that would deliver a health behavior intervention to this population.
A formative phase focused on intervention and software development will be followed by a pilot/feasibility test of the intervention. Participants in the intervention will receive a customized study-designed mobile phone app with a social networking component in which users will be able to support one another. They will also receive personal support from a health counselor to help set goals and discuss areas of concern.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473342
|United States, North Carolina|
|Duke University Medical Center, Dept. of Community and Family Medicine|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Bernard F. Fuemmeler, Ph.D., MPH||Duke University Health System|