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

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ClinicalTrials.gov Identifier: NCT01358448
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : July 19, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Behavioral: growth monitoring Behavioral: Growth Monitoring plus Family-based Behavioral Counseling

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity
Actual Study Start Date : April 2011
Primary Completion Date : July 2014
Study Completion Date : July 2014
Arms and Interventions

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

Outcome Measures

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

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

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Hollie Raynor, Professor, University of Tennessee
ClinicalTrials.gov Identifier: NCT01358448     History of Changes
Other Study ID Numbers: UT8433B
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Hollie Raynor, University of Tennessee:
Treatment of childhood obesity

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms