A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: growth monitoring; Behavioral: Growth Monitoring plus Family-based Behavioral Counseling

• Registration Number: NCT01358448
• Lead Sponsor: The University of Tennessee, Knoxville

Brief Summary

In 2007 the Expert Committee published recommendations on the prevention and treatment of childhood obesity. These recommendations outlined four interventions intended for advancement based on the child's age, body mass index (BMI), and response to treatment. The initial stage, Prevention Plus, is to be implemented in the primary care setting and focuses on primary care providers monitoring growth monthly and delivering intervention messages that target dietary and leisure-time behaviors that most contribute to energy imbalance in children. Little research has evaluated the efficacy of these recommendations. Thus the primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus stage for treating childhood overweight and obesity in a primary care setting. As the cost of interventions is a large barrier to the translation of evidence-based research into primary care settings, a second goal of the project is to evaluate program cost-effectiveness.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• between 4 to 8 years of age at the start of the intervention
• overweight or obese (≥85th BMI-for-age percentile)
• have no medical conditions that effect growth, intake or physical activity (e.g., Prader Willi Syndrome, type 2 diabetes, etc.)
• not currently participating in a weight loss program and/or taking weight loss medication
• have a primary caretaker willing to participate in the research study, receive monthly newsletters and be randomized to one of the three conditions
• caretaker must be able to read, speak and understand English and the child speak English
• have transportation to their child's primary care provider office
• family does not plan to move out of the area before March 2012

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Growth Monitoring	growth monitoring	-
Growth Monitoring plus Family-based Behavioral Counseling	Growth Monitoring plus Family-based Behavioral Counseling	-

Primary Outcome Measures

Name	Time	Method
Weight Status	Baseline and 6-month	BMI z-score
Dietary Intake	baseline and 6-months	dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)
Leisure-time Behaviors	Baseline and 6-months	leisure-time behaviors (moderate-intense physical activity and television viewing)
Caretaker Feeding Behaviors	Baseline and 6-months	Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires

Secondary Outcome Measures

Name	Time	Method
Cost Effectiveness	6-months	The total program cost per 0.1 change in BMI z-score

Trial Locations

Locations (2)

Knoxville Pediatric Associates; 🇺🇸 Knoxville, Tennessee, United States

Healthy Eating and Activity Laboratory; 🇺🇸 Knoxville, Tennessee, United States