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Completed

NCT Number: NCT01969760

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

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.

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Key information

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy Families DC Program

Behavioral

A tailored family-based intervention for health promotion goal setting, substance use prevention, and promotion of physical activity

Primary outcomes

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

    Time frame: 8-weeks

Secondary outcomes

  1. Smoking Susceptibility Scale changes from baseline to 8-weeks post-baseline

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Cassandra Stanton, PhD

Other

Registry information

Acronym: HFDC

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 25, 2013
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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