Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity (HFDC)
Primary Purpose
Smoking, Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Families DC Program
Sponsored by
About this trial
This is an interventional prevention trial for Smoking
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Georgetown University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Wait-list control
Healthy Families DC Program
Arm Description
Wait-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
Outcomes
Primary Outcome Measures
Actigraphy-based changes in physical activity from baseline to 8-weeks post-baseline
Secondary Outcome Measures
Smoking Susceptibility Scale changes from baseline to 8-weeks post-baseline
Full Information
NCT ID
NCT01969760
First Posted
October 22, 2013
Last Updated
January 26, 2015
Sponsor
Cassandra Stanton, PhD
1. Study Identification
Unique Protocol Identification Number
NCT01969760
Brief Title
Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity
Acronym
HFDC
Official Title
Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cassandra Stanton, PhD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Low income ethnic minority youth tend to be at greater risk for obesity, physical inactivity, high risk behaviors such as tobacco and substance use and resulting cardiovascular and chronic disease. In this study we modified a tobacco and substance use risk prevention program to develop a tailored intervention (Healthy Families DC) that also included promotion of physical activity (PA) for DC middle-school students referred by school staff as over-weight and at risk for problem behaviors. The program included an initial family assessment, a family feedback session with family PA goal setting and 6 phone/text based booster sessions. A pilot study with 18 families, comprised of at least one caregiver and target child, was conducted to examine feasibility, acceptability, and trends in preliminary outcomes such as PA via self-report and accelerometry, health risk behaviors (e.g., tobacco use), health goal setting, and changes in family functioning (e.g., youth positive behaviors, parenting).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Overweight, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Wait-list control. No intervention delivered until post follow-up assessment. Upon completion of the follow-up, the family was offered the full intervention.
Arm Title
Healthy Families DC Program
Arm Type
Experimental
Arm Description
Healthy Families DC Program
Intervention Type
Behavioral
Intervention Name(s)
Healthy Families DC Program
Intervention Description
A tailored family-based intervention for health promotion goal setting, substance use prevention, and promotion of physical activity
Primary Outcome Measure Information:
Title
Actigraphy-based changes in physical activity from baseline to 8-weeks post-baseline
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Smoking Susceptibility Scale changes from baseline to 8-weeks post-baseline
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassandra A Stanton, PhD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity
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