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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by University of Tennessee.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
University of Tennessee Identifier:
First received: May 17, 2011
Last updated: May 28, 2015
Last verified: May 2015
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.

Condition Intervention
Behavioral: growth monitoring
Behavioral: Growth Monitoring plus Family-based Behavioral Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Weight Status [ Time Frame: Baseline and 6-month ]
    BMI z-score

  • Dietary Intake [ Time Frame: baseline and 6-months ]
    dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)

  • Leisure-time Behaviors [ Time Frame: Baseline and 6-months ]
    leisure-time behaviors (moderate-intense physical activity and television viewing)

  • Caretaker Feeding Behaviors [ Time Frame: Baseline and 6-months ]
    Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires

Secondary Outcome Measures:
  • Cost Effectiveness [ Time Frame: 6-months ]
    The total program cost per 0.1 change in BMI z-score

Estimated Enrollment: 33
Study Start Date: April 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01358448

United States, Tennessee
Knoxville Pediatric Associates
Knoxville, Tennessee, United States, 37923
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
University of Tennessee
  More Information

Responsible Party: University of Tennessee Identifier: NCT01358448     History of Changes
Other Study ID Numbers: UT8433B
Study First Received: May 17, 2011
Last Updated: May 28, 2015

Keywords provided by University of Tennessee:
Treatment of childhood obesity

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on May 25, 2017