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Clinical Trials/NCT01969760
NCT01969760
Completed
N/A

Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity

Cassandra Stanton, PhD1 site in 1 country18 target enrollmentOctober 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Smoking
Sponsor
Cassandra Stanton, PhD
Enrollment
18
Locations
1
Primary Endpoint
Actigraphy-based changes in physical activity from baseline to 8-weeks post-baseline
Status
Completed
Last Updated
11 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
May 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cassandra Stanton, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Cassandra Stanton, PhD

Adjunct Assistant Professor of Oncology

Georgetown University

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.

Outcomes

Primary Outcomes

Actigraphy-based changes in physical activity from baseline to 8-weeks post-baseline

Time Frame: 8-weeks

Secondary Outcomes

  • Smoking Susceptibility Scale changes from baseline to 8-weeks post-baseline(8 weeks)

Study Sites (1)

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