This trial is active, not recruiting.

Condition obesity
Treatments growth monitoring, growth monitoring plus family-based behavioral counseling
Sponsor University of Tennessee
Start date April 2011
End date March 2016
Trial size 33 participants
Trial identifier NCT01358448, UT8433B


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(No Intervention)
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

Primary Outcomes

Weight Status
time frame: Baseline and 6-month
Dietary Intake
time frame: baseline and 6-months
Leisure-time Behaviors
time frame: Baseline and 6-months
Caretaker Feeding Behaviors
time frame: Baseline and 6-months

Secondary Outcomes

Cost Effectiveness
time frame: 6-months

Eligibility Criteria

Male or female participants from 4 years up to 8 years old.

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

Additional Information

Official title A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Tennessee.