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Mila Blooms Intervention Study

2014年10月23日更新者：Duke University

Mila Blooms Intervention Study: An App for Promoting Physical Activity and Health Diet Among Adolescent Survivors of Childhood Cancer

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.

研究概览

地位

完全的

条件

儿童癌症

干预/治疗

行为的：Mila Blooms

详细说明

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.

研究类型

介入性

注册 (实际的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- North Carolina
  - Durham、North Carolina、美国、27705
    - Duke University Medical Center, Dept. of Community and Family Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年至 19年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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;

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

分配：不适用
介入模型：单组作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
其他：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).	行为的：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.

参与者组/臂

干预/治疗

其他：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).

行为的：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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Feasibility of the Mila Blooms Intervention at changing health behaviors. 大体时间：~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.	~9 weeks (from pre-intervention baseline to post-intervention follow-up)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Duke University

合作者

National Cancer Institute (NCI)

调查人员

首席研究员：Bernard F. Fuemmeler, Ph.D., MPH、Duke Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年4月1日

初级完成 (实际的)

2013年9月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2011年11月14日

首先提交符合 QC 标准的

2011年11月16日

首次发布 (估计)

2011年11月17日

研究记录更新

最后更新发布 (估计)

2014年10月24日

上次提交的符合 QC 标准的更新

2014年10月23日

最后验证

2014年10月1日

Mila Blooms Intervention Study