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Mila Blooms Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01473342
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : October 24, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment
Childhood Cancer Behavioral: Mila Blooms

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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
Study Start Date : April 2011
Primary Completion Date : September 2013
Study Completion Date : July 2014

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01473342

United States, North Carolina
Duke University Medical Center, Dept. of Community and Family Medicine
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Principal Investigator: Bernard F. Fuemmeler, Ph.D., MPH Duke University Health System

Responsible Party: Duke University Identifier: NCT01473342     History of Changes
Other Study ID Numbers: Pro00029579
1R21CA155965-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014

Keywords provided by Duke University:
Healthy survivorship