Mila Blooms Intervention Study
| Tracking Information | |||||
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| First Received Date ICMJE | November 14, 2011 | ||||
| Last Updated Date | March 11, 2013 | ||||
| Start Date ICMJE | April 2011 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Feasibility of the Mila Blooms Intervention at changing health behaviors. [ Time Frame: ~9 weeks (from pre-intervention baseline to post-intervention follow-up) ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE |
Feasibility of the FitFab Intervention changing health behaviors. [ Time Frame: ~10 weeks post-baseline ] [ Designated as safety issue: No ] Test the feasibility of the FitFab 4 Survivors intervention at changing diet, physical activity, body mass index (BMI), and social cognitive mediators of health behavior change. |
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| Change History | Complete list of historical versions of study NCT01473342 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Mila Blooms Intervention Study | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | This study is focused on the development and pilot/feasibility testing of a smartphone application to promote a healthy diet, increase physical activity, and prevent weight gain in adolescent survivors of childhood cancer. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | Childhood Cancer | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | 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).
Intervention: Behavioral: Mila Blooms |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years to 19 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01473342 | ||||
| Other Study ID Numbers ICMJE | Pro00029579, 1R21CA155965-01A1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Duke University | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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