Mila Blooms Intervention Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01473342
First received: November 14, 2011
Last updated: September 16, 2013
Last verified: September 2013

November 14, 2011
September 16, 2013
April 2011
September 2013   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01473342 on ClinicalTrials.gov Archive Site
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Mila Blooms Intervention Study
Not Provided

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Childhood Cancer
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
October 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants must speak & read/write fluent English;
  • Adolescent must be between 12 and 19 years of age;
  • Adolescent must have a previous diagnosis of childhood Acute Lymphoblastic Leukemia;
  • Adolescent must be "off-therapy" (i.e., not in active or maintenance phase of cancer therapy) for at least 2 years;
  • Adolescent must be cleared by his/her physician to participate (defined by obtaining a score of 80 or greater on the Karnofsky Scale as determined by their physician);
  • Participants must have a working phone number;
  • Adolescents must live at home with parents in order to facilitate parent involvement via support materials.

Exclusion Criteria:

  • Physician reports that the patient has deficits in neurocognitive functioning that would preclude him/her from participating in a cognitive-oriented intervention;
Both
12 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01473342
Pro00029579, 1R21CA155965-01A1
Yes
Duke University
Duke University
National Cancer Institute (NCI)
Principal Investigator: Bernard F. Fuemmeler, Ph.D., MPH Duke University Health System
Duke University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP