NCT01473342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

2.4 years

First QC Date

November 14, 2011

Last Update Submit

October 23, 2014

Conditions

Childhood Cancer

Keywords

Healthy survivorshipSmartphonesTreatment

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the Mila Blooms Intervention at changing health behaviors.

    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)

Study Arms (1)

Control & Intervention Phases

OTHER

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

Interventions

Mila BloomsBEHAVIORAL

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

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center, Dept. of Community and Family Medicine

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Bernard F. Fuemmeler, Ph.D., MPH

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 17, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2013

Study Completion

July 1, 2014

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

US(1)