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

Not Applicable

Completed

• Conditions: Overweight; Obesity; Smoking
• Interventions: Behavioral: Healthy Families DC Program

• Registration Number: NCT01969760
• Lead Sponsor: Cassandra Stanton, PhD

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).

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-25
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Families DC Program	Healthy Families DC Program	Healthy Families DC Program

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Smoking Susceptibility Scale changes from baseline to 8-weeks post-baseline	8 weeks

Trial Locations

Locations (1)

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States