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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358448
• Other study ID #: UT8433B
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: April 3, 2018
• Start date: April 2011
• Est. completion date: July 2014

Study information

• Verified date: April 2018
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• growth monitoring
Caretakers will be encouraged to monitor child growth monthly.
• Growth Monitoring plus Family-based Behavioral Counseling
Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling

Locations

Country	Name	City	State
United States	Healthy Eating and Activity Laboratory	Knoxville	Tennessee
United States	Knoxville Pediatric Associates	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Status	BMI z-score	Baseline and 6-month
Primary	Dietary Intake	dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)	baseline and 6-months
Primary	Leisure-time Behaviors	leisure-time behaviors (moderate-intense physical activity and television viewing)	Baseline and 6-months
Primary	Caretaker Feeding Behaviors	Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires	Baseline and 6-months
Secondary	Cost Effectiveness	The total program cost per 0.1 change in BMI z-score	6-months