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

NCT ID: NCT01969760

Last Updated: 2015-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-05-31

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).

Conditions

Smoking; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Wait-list control

Wait-list control. No intervention delivered until post follow-up assessment. Upon completion of the follow-up, the family was offered the full intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Families DC Program

Healthy Families DC Program

Group Type: EXPERIMENTAL

Healthy Families DC Program

Intervention Type: BEHAVIORAL

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

Interventions

Healthy Families DC Program

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cassandra Stanton, PhD

OTHER

Sponsor Role: lead

Responsible Party

Cassandra Stanton, PhD

Adjunct Assistant Professor of Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cassandra A Stanton, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University Medical Center

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

Countries

United States

Other Identifiers

2013-0614

Identifier Type: -

Identifier Source: org_study_id