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

Obesity Clinical Trial

— HFDC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969760
• Other study ID #: 2013-0614
• Status: Completed
• Phase: N/A
• First received: October 22, 2013
• Last updated: January 26, 2015
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: January 2015
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight
• Smoking

Intervention

Behavioral:
• Healthy Families DC Program
A tailored family-based intervention for health promotion goal setting, substance use prevention, and promotion of physical activity

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cassandra Stanton, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actigraphy-based changes in physical activity from baseline to 8-weeks post-baseline		8-weeks	No
Secondary	Smoking Susceptibility Scale changes from baseline to 8-weeks post-baseline		8 weeks	No