Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity
HFDC
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to examine the feasibility and acceptability of a family-based program to improve physical activity and tobacco outcomes in a small pilot of middle school students and their families.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
Shorter than P25 for not_applicable
1 active site
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
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 22, 2013
CompletedFirst Posted
Study publicly available on registry
October 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJanuary 28, 2015
January 1, 2015
7 months
October 22, 2013
January 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Actigraphy-based changes in physical activity from baseline to 8-weeks post-baseline
8-weeks
Secondary Outcomes (1)
Smoking Susceptibility Scale changes from baseline to 8-weeks post-baseline
8 weeks
Study Arms (2)
Wait-list control
NO INTERVENTIONWait-list control. No intervention delivered until post follow-up assessment. Upon completion of the follow-up, the family was offered the full intervention.
Healthy Families DC Program
EXPERIMENTALHealthy Families DC Program
Interventions
A tailored family-based intervention for health promotion goal setting, substance use prevention, and promotion of physical activity
Eligibility Criteria
You may qualify if:
- Students aged 12-16 years
- Attending regular education classes at three urban DC public middle schools. -Students must currently reside with at least one parent or guardian who wishes to also participate in this study.
- Students and at least one guardian must be fluent in English
You may not qualify if:
- Adolescents, who are outside the study age range
- Patients/parents unable to speak/read English
- Are wards of the state
- Not attending regular education classes at the public middle schools -Furthermore, adolescents and guardians not assenting/consenting to be in the study will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cassandra A Stanton, PhD
Georgetown University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Adjunct Assistant Professor of Oncology
Study Record Dates
First Submitted
October 22, 2013
First Posted
October 25, 2013
Study Start
October 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
January 28, 2015
Record last verified: 2015-01