Mila Blooms Intervention Study

Not Applicable

Completed

• Conditions: Childhood Cancer
• Interventions: Behavioral: Mila Blooms

• Registration Number: NCT01473342
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Primary Completion: 2013-09
• Study Completion: 2014-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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Exclusion Criteria

• Physician reports that the patient has deficits in neurocognitive functioning that would preclude him/her from participating in a cognitive-oriented intervention;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control & Intervention Phases	Mila Blooms	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).

Primary Outcome Measures

Name	Time	Method
Feasibility of the Mila Blooms Intervention at changing health behaviors.	~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.

Trial Locations

Locations (1)

Duke University Medical Center, Dept. of Community and Family Medicine; 🇺🇸 Durham, North Carolina, United States