NCT03143660

FITLINE: Pediatric Practice-based Obesity Intervention to Support Families

Pediatric Practice-based Obesity Intervention to Support Families:FITLINE

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to investigate whether eight weekly telephone coaching sessions or materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year olds.

Detailed description

The proposed five-year cluster randomized controlled pediatric practice-based trial will compare the effectiveness of two practice-based interventions on improving diet and physical activity and reducing BMI among overweight and obese 8-12 year olds seen in pediatric practice: (1) Fitline-Coaching, consisting of a pediatric practice-based component plus Fitline counseling and workbook, or (2) Fitline-Workbook, consisting of the same practice-based component, but only the family workbook materials mailed over 8 weeks, with no referral to Fitline coaching. Sixteen pediatric primary care practices will be randomized to either the Fitline-Coaching (N=8) or the Fitline-Materials (N=8) condition. Five hundred and twelve parents and their children ages 8-12 with a body mass index (BMI) of \> 85th percentile (overweight or obese) will be recruited from the practices to achieve N=400 at 12 month follow-up.

Conditions

• Obesity, Childhood

Interventions

Type	Name	Description
BEHAVIORAL	Coaching	The eight weekly 30-minute Fitline calls provide personalized behavioral counseling and coaching to guide parents in improving their child's weight-related behaviors through targeted lifestyle changes recommended by the AAP for Stage 1, Prevention Plus. Calls are scheduled at a time convenient for the parent, including nights and weekends, with one nutritionist assigned to a family for consistency.
BEHAVIORAL	Materials	The workbook contains tips and practical strategies for implementing the AAP-recommended behavior changes discussed in the counseling sessions to support families in making lifestyle changes.

Timeline

• Start date: 2017-10-11
• Primary completion: 2022-01-01
• Completion: 2022-01-28
• First posted: 2017-05-08
• Last updated: 2022-01-31

Locations

1 site across 1 country: United States