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

NCT ID: NCT01358448

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-07-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Newsletter

Group Type: NO_INTERVENTION

No interventions assigned to this group

Growth Monitoring

Group Type: EXPERIMENTAL

growth monitoring

Intervention Type: BEHAVIORAL

Caretakers will be encouraged to monitor child growth monthly.

Growth Monitoring plus Family-based Behavioral Counseling

Group Type: EXPERIMENTAL

Growth Monitoring plus Family-based Behavioral Counseling

Intervention Type: BEHAVIORAL

Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling

Interventions

growth monitoring

Caretakers will be encouraged to monitor child growth monthly.

Intervention Type: BEHAVIORAL

Growth Monitoring plus Family-based Behavioral Counseling

Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Tennessee, Knoxville

OTHER

Sponsor Role: lead

Responsible Party

Hollie Raynor

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Knoxville Pediatric Associates

Knoxville, Tennessee, United States

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

UT8433B

Identifier Type: -

Identifier Source: org_study_id