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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: growth monitoring; Behavioral: Growth Monitoring plus Family-based Behavioral Counseling

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • Healthy Eating and Activity Laboratory
    • Knoxville, Tennessee, United States, 37923
      • Knoxville Pediatric Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Newsletter
Experimental: Growth Monitoring	Behavioral: growth monitoring; Caretakers will be encouraged to monitor child growth monthly.
Experimental: Growth Monitoring plus Family-based Behavioral Counseling	Behavioral: Growth Monitoring plus Family-based Behavioral Counseling; Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Effectiveness	The total program cost per 0.1 change in BMI z-score	6-months

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 17, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 23, 2011

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Treatment of childhood obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: UT8433B